How do I buy prescription medication?

Loxicom Oral for Dogs & Cats

Loxicom Oral for Dogs & Cats
1mg Chewable Tablets » Priced per Tablet

  • 1mg Chewable Tablets » Priced per Tablet £0.49
  • 2.5mg Chewable Tablets » Priced per Tablet £1.00
  • Cats » 5ml Bottle £8.50
  • Dogs » 15ml Bottle £13.49
  • Dogs » 32ml Bottle £16.00

Selection of 5 products from

£0.49 to £16.00

Description

Loxicom is supplied as a liquid to add to food or as tablets. It contains the well known and trusted veterinary drug meloxicam. This is a non-steroidal anti-inflammatory drug which is used to provide relief from the stiffness and discomfort associated with osteoarthritis in the dog and cat. It is also used for other painful, inflammatory conditions, especially of the musculo-skeletal system, such as injuries. It can be given for a short course in acute conditions, or can be given for long periods of time in chronic conditions.

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs Do not use in pregnant or lactating animals.
Initial treatment is a single dose of 0.2mg meloxicam/kg bodyweight (i.e.1.33ml/10 kg bodyweight) on the first day. Treatment is to be continued once daily by oral administration (at 24 hour interval) at a maintenance dose of 0.1mg meloxicam/kg bodyweight (i.e. 0.667ml/10kg bodyweight).
For longer term treatment, once clinical response has been observed (after 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.
For oral use. To be administered with food or directly into the mouth. shake well before use.
The suspension can be given using either of the two measuring syringes provided in the package. The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1mg meloxicam/kg bodyweight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent. Avoid introduction of contamination during use.
Each ml contains: Meloxicam 1.5mg/ml Sodium benzoate 1.5mg
Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impared hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 6 weeks of age. Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, treatment shoud be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. In the case of overdose symptomatic treatment should be initiated.

Need help or advice? Contact us:

  • Landline: 01582 842096
  • Mon - Fri: 8:30am - 5:00pm
  • Sat: 9:00am - 1:00pm (Collections only)
  • Email: [email protected]

All prices include VAT where applicable.

Medication Datasheets

Dogs » 32ml Bottle

Loxicom 0.5 mg/ml Oral Suspension for Dogs

Qualitative and quantitative composition

Each ml contains:

Active Substance: Meloxicam 0.5 mg

Excipients: Sodium benzoate 1.5 mg

Pharmaceutical form

Pale yellow oral suspension.

Clinical particulars

Target species

Dogs.

Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Contraindications

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients

Do not use in dogs less than 6 weeks of age.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Amounts to be administered and administration route

Oral use.

To be administered with food or directly into the mouth.

Shake well before use.

Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 4 ml/10 kg bodyweight) on the first day. Treatment is to be continued once daily by oral administration (at 24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg bodyweight (i.e. 2 ml/10 kg bodyweight).

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.

The suspension can be given using either of the two measuring syringes provided in the package. The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Loxicom 5 mg/ml solution for injection.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose, symptomatic treatment should be initiated.

Pharmacological particulars

Pharmacotherapeutic Group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).

ATCvet code: QM01AC06

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic particulars

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.

Pharmaceutical particulars

List of excipients

Sodium Benzoate

Glycerol

Povidone K30

Xanthan Gum

Disodium Phosphate Dihydrate

Sodium Dihydrogen Phosphate Dihydrate

Citric Acid Anhydrous

Simethicone Emulsion

Purified water

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other

veterinary medicinal products.

Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months

Shelf-life after first opening the immediate packaging: 6 months

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Nature and composition of immediate packaging

The veterinary medicinal product is presented in 15 ml and 30 ml polyethylene screw bottles with HDPE/LDPE child resistant caps. Two polyethylene/polypropylene measuring syringes, a 1 ml and a 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs. Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.25 kg to 5.0 kg and the 5 ml syringe for 1 kg to 25 kg.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

Marketing Authorisation Number

EU/2/08/090/001

Date of the first authorisation or date of renewal

Date of first authorisation: 10/02/2009

Date of last renewal: 12/03/2014

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

Any other information

Nil.

Legal category

Dogs » 15ml Bottle

experienced more than one episode of the adverse reaction during the study.In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).Post-Approval Experience (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system. Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal ulcerationUrinary: azotemia, elevated creatinine, renal failureNeurological/Behavioral: lethargy, depressionHepatic: elevated liver enzymesDermatologic: pruritusDeath has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with use of meloxicam in cats. To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assistance, call Norbrook at 1-866-591-5777. For a complete listing of adverse reactions for meloxicam reported to the CVM see:http://www.fda.gov/ADEreports.Information for Dog OwnersLoxicom, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue Loxicom and contact their veterinarian immediately if signs of intolerance are observed.The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.Clinical Pharmacology: Meloxicam has nearly 100% bioavailability when administered orally with food. The terminal elimination half-life after a single dose is estimated to be approximately 24 hrs (+/-30%) regardless of route of administration. There is no evidence of statistically significant gender differences in drug pharmacokinetics. Drug bioavailability, volume of distribution, and total systemic clearance remain constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45 days or longer. Peak drug concentrations can be expected to occur within about 7.5 hrs after oral administration. Corresponding peak concentration is approximately 0.464 mcg/mL following a 0.2 mg/kg oral dose. The drug is 97% bound to canine plasma proteins.Effectiveness: The effectiveness of meloxicam was demonstrated in two field studies involving a total of 277 dogs representing various breeds, between six months and sixteen years of age, all diagnosed with osteoarthritis. Both of the placebo-controlled, masked studies were conducted for 14 days. All dogs received 0.2 mg/kg on day 1. All dogs were maintained on 0.1 mg/kg oral meloxicam from days 2 through 14 of both studies. Parameters evaluated by veterinarians included lameness, weight-bearing, pain on palpation, and overall improvement. Parameters assessed by owners included mobility, ability to rise, limping, and overall improvement. In the first field study (n=109), dogs showed clinical improvement with statistical significance after 14 days of meloxicam treatment for all parameters. In the second field study (n=48), dogs receiving meloxicam showed a clinical improvement after 14 days of therapy for all parameters; however, statistical significance was demonstrated only for the overall investigator evaluation on day 7, and for the owner evaluation on day 14.Safety:Six Week StudyIn a six week target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no significant clinical adverse reactions. Animals in all dose groups (control, 1, 3 and 5X the recommended dose) exhibited some gastrointestinal distress (diarrhea and vomiting). No treatment-related changes were observed in hematological, blood chemistry, urinalysis, clotting time, or buccal mucosal bleeding times. Necropsy results included stomach mucosal petechiae in one control dog, two dogs at the 3X and one dog at the 5X dose. Other macroscopic changes included areas of congestion or depression of the mucosa of the jejunum or ileum in three dogs at the 1X dose and in two dogs at the 5X dose. Similar changes were also seen in two dogs in the control group. There were no macroscopic small intestinal lesions observed in dogs receiving the 3X dose. Renal enlargement was reported during the necropsy of two dogs receiving the 3X and two receiving the 5X dose.Microscopic examination of the kidneys revealed minimal degeneration or slight necrosis at the tip of the papilla in three dogs at the 5X dose. Microscopic examination of the stomach showed inflammatory mucosal lesions, epithelial regenerative hyperplasia or atrophy, and submucosal gland inflammation in two dogs at the recommended dose, three dogs at the 3X and four dogs at the 5X dose. Small intestinal microscopic changes included minimal focal mucosal erosion affecting the villi, and were sometimes associated with mucosal congestion. These lesions were observed in the ileum of one control dog and in the jejunum of one dog at the recommended dose and two dogs at the 5X dose.Six Month Study In a six month target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no significant clinical adverse reactions. All animals in all dose groups (controls, 1, 3, and 5X the recommended dose) exhibited some gastrointestinal distress (diarrhea and vomiting). Treatment related changes seen in hematology and chemistry included decreased red blood cell counts in seven of 24 dogs (four 3X and three 5X dogs), decreased hematocrit in 18 of 24 dogs (including three control dogs), dose-related neutrophilia in one 1X, two 3X and three 5X dogs, evidence of regenerative anemia in two 3X and one 5X dog. Also noted were increased BUN in two 5X dogs and decreased albumin in one 5X dog.Endoscopic changes consisted of reddening of the gastric mucosal surface covering less than 25% of the surface area. This was seen in three dogs at the recommended dose, three dogs at the 3X dose and two dogs at the 5X dose. Two control dogs exhibited reddening in conjunction with ulceration of the mucosa covering less than 25% of the surface area.Gross gastrointestinal necropsy results observed included mild discoloration of the stomach or duodenum in one dog at the 3X and in one dog at the 5X dose. Multifocal pinpoint red foci were observed in the gastric fundic mucosa in one dog at the recommended dose, and in one dog at the 5X dose.No macroscopic or microscopic renal changes were observed in any dogs receiving meloxicam in this six month study. Microscopic gastrointestinal findings were limited to one dog at the recommended dose, and two dogs at the 3X dose. Mild inflammatory mucosal infiltrate was observed in the duodenum of one dog at the recommended dose. Mild congestion of the fundic mucosa and mild myositis of the outer mural musculature of the stomach were observed in two dogs receiving the 3X dose.How Supplied:Loxicom Oral Suspension 1.5 mg/mL: 10, 32 and 100 mL bottles with small and large dosing syringes.Storage: Store at controlled room temperature 68-77°F (20-25°C). Excursions permitted between 59°F and 86°F (15°C and 30°C). Brief exposure to temperature up to 104° F (40°C) may be tolerated provided the mean kinetic temperature does not exceed 77°F (25°C); however such exposure should be minimized.Made in the UK.Manufactured by:Norbrook Laboratories LimitedNewry, BT35 6PU, Co. Down, Northern IrelandLoxicom® is a registered trademarkof Norbrook Laboratories LimitedLoxicom®(meloxicam)1.5 mg/mL Oral SuspensionmeloxicamProfessional InsertANADA 200-497, Approved by FDANon-steroidal anti-inflammatory drug for oral use in dogs onlyCaution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each milliliter of Loxicom® Oral Suspension contains meloxicam equivalent to 1.5 milligrams and sodium benzoate (1.5 milligrams) as a preservative. The chemical name for Meloxicam is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carbox-amide-1, 1-dioxide. The formulation is a yellowish viscous suspension. Indications: Loxicom Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.Dosage and Administration:Always provide client information sheet with prescription. Carefully consider the potential benefits and risk of Loxicom Oral Suspension and other treatment options before deciding to use Loxicom Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual response. Loxicom Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Loxicom Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg). The syringes are calibrated to deliver the daily maintenance dose in lbs. Because the first dose (0.2 mg/kg) is two times the amount of the daily maintenance dose (0.1 mg/kg), two syringes containing the 0.1 mg/kg dose should be administered at the first dose.Directions for Administration:Loxicom Oral Suspension is packaged with 2 sizes of dosing syringes. The small syringe is calibrated in 1-lb increments for use in dogs under 30 lbs. The large syringe is calibrated in 5-lb increments (up to 160 lbs.) and should be used for dosing dogs that are 30 lbs and over. Only administer Loxicom with theprovided syringes. The container should never be used as a dropper bottle for administration of Loxicom.Dogs under 30 lbs (13.6 kg)Shake well before use, then remove cap. Loxicom Oral Suspension can be given either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, only use the small dosing syringe. The large syringe provided should not be used to measure doses for dogs weighing less than 30 lbs (13.6 kg). For dogs under 30 lbs, use the small dosing syringe provided in the package (see dosing procedure below). The small dosing syringe fits onto the bottle and has dosing marks in 1-lb increments, designed to deliver the daily maintenance dose of 0.045 mg/lb (0.1 mg/kg). For dogs between 1 - 29 lbs, Loxicom can be given using the marks on the small dosing syringe. When using the small dosing syringe, the dog’s weight should be rounded down to the nearest 1-lb increment. Replace and tighten cap after use.Dogs 30 lbs (13.6 kg) and overShake well before use, then remove cap. Loxicom may be either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, do not use the large syringe in animals weighing less than 30 pounds.For dogs 30 lbs or greater, the large dosing syringe provided in the package should be used (see dosing procedure below). The large dosing syringe fits onto the bottle and has dosing marks in 5-lb increments (up to 160 lbs), designed to deliver the daily maintenance dose of 0.045 mg/lb (0.1 mg/kg). When using the large syringe, the dog’s weight should be rounded down to the nearest 5-lb increment. Replace and tighten cap after use.Contraindications: Dogs with known hypersensitivity to meloxicam should not receive Loxicom Oral Suspension. Do not use Loxicom Oral Suspension in cats. Acute renal failure and death have been associated with the use of meloxicam in cats.Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For oral use in dogs only.As with any NSAID all dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and periodically during administration. Owner should be advised to observe their dog for signs of potential drug toxicity and be given a client information sheet about Loxicom.Precautions: The safe use of Loxicom Oral Suspension in dogs younger than 6 months of age, dogs used for breeding, or in pregnant or lactating dogs has not been evaluated. Meloxicam is not recommended for use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient.Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or perforations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after administration of the total daily dose of Loxicom Oral Suspension, a non-NSAID or non-corticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly protein-bound drugs with Loxicom Oral Suspension has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Loxicom Oral Suspension has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.Adverse Reactions: Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have Adverse Reactions Observed During Two Field StudiesClinical Observation Meloxicam Placebo(n=157) (n=149)Vomiting 40 23Diarrhea/Soft Stool 19 11Bloody Stool 1 0Inappetance 5 1Bleeding gums after dental procedure 1 0Lethargy/Swollen Carpus 1 0Epiphora 1 0TAKE TIMEOBSERVE LABELDIRECTIONSUPDOWNShake bottle well. Push downand unscrew bottle top. Attachthe dosing syringe to the bottleby gently pushing the end ontothe top of the bottle.12Turn the bottle right way up andwith a twisting movementseparate the dosing syringefrom the bottle.Turn the bottle/syringe upside down. Pull the plunger out until the medication level corresponds to the dog's body weight in pounds.Push the plunger to empty thecontents of the syringe on food or directly in the mouth.orLoxicom 1.5mg/mL Oral SuspensionProfessional InsertScale: 100%Dimensions: 148 x 210 mmText - ≥ 6.5pt 082670I01 experienced more than one episode of the adverse reaction during the study.In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).Post-Approval Experience (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system. Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal ulcerationUrinary: azotemia, elevated creatinine, renal failureNeurological/Behavioral: lethargy, depressionHepatic: elevated liver enzymesDermatologic: pruritusDeath has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with use of meloxicam in cats. To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assistance, call Norbrook at 1-866-591-5777. For a complete listing of adverse reactions for meloxicam reported to the CVM see:http://www.fda.gov/ADEreports.Information for Dog OwnersLoxicom, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue Loxicom and contact their veterinarian immediately if signs of intolerance are observed.The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.Clinical Pharmacology: Meloxicam has nearly 100% bioavailability when administered orally with food. The terminal elimination half-life after a single dose is estimated to be approximately 24 hrs (+/-30%) regardless of route of administration. There is no evidence of statistically significant gender differences in drug pharmacokinetics. Drug bioavailability, volume of distribution, and total systemic clearance remain constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45 days or longer. Peak drug concentrations can be expected to occur within about 7.5 hrs after oral administration. Corresponding peak concentration is approximately 0.464 mcg/mL following a 0.2 mg/kg oral dose. The drug is 97% bound to canine plasma proteins.Effectiveness: The effectiveness of meloxicam was demonstrated in two field studies involving a total of 277 dogs representing various breeds, between six months and sixteen years of age, all diagnosed with osteoarthritis. Both of the placebo-controlled, masked studies were conducted for 14 days. All dogs received 0.2 mg/kg on day 1. All dogs were maintained on 0.1 mg/kg oral meloxicam from days 2 through 14 of both studies. Parameters evaluated by veterinarians included lameness, weight-bearing, pain on palpation, and overall improvement. Parameters assessed by owners included mobility, ability to rise, limping, and overall improvement. In the first field study (n=109), dogs showed clinical improvement with statistical significance after 14 days of meloxicam treatment for all parameters. In the second field study (n=48), dogs receiving meloxicam showed a clinical improvement after 14 days of therapy for all parameters; however, statistical significance was demonstrated only for the overall investigator evaluation on day 7, and for the owner evaluation on day 14.Safety:Six Week StudyIn a six week target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no significant clinical adverse reactions. Animals in all dose groups (control, 1, 3 and 5X the recommended dose) exhibited some gastrointestinal distress (diarrhea and vomiting). No treatment-related changes were observed in hematological, blood chemistry, urinalysis, clotting time, or buccal mucosal bleeding times. Necropsy results included stomach mucosal petechiae in one control dog, two dogs at the 3X and one dog at the 5X dose. Other macroscopic changes included areas of congestion or depression of the mucosa of the jejunum or ileum in three dogs at the 1X dose and in two dogs at the 5X dose. Similar changes were also seen in two dogs in the control group. There were no macroscopic small intestinal lesions observed in dogs receiving the 3X dose. Renal enlargement was reported during the necropsy of two dogs receiving the 3X and two receiving the 5X dose.Microscopic examination of the kidneys revealed minimal degeneration or slight necrosis at the tip of the papilla in three dogs at the 5X dose. Microscopic examination of the stomach showed inflammatory mucosal lesions, epithelial regenerative hyperplasia or atrophy, and submucosal gland inflammation in two dogs at the recommended dose, three dogs at the 3X and four dogs at the 5X dose. Small intestinal microscopic changes included minimal focal mucosal erosion affecting the villi, and were sometimes associated with mucosal congestion. These lesions were observed in the ileum of one control dog and in the jejunum of one dog at the recommended dose and two dogs at the 5X dose.Six Month Study In a six month target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no significant clinical adverse reactions. All animals in all dose groups (controls, 1, 3, and 5X the recommended dose) exhibited some gastrointestinal distress (diarrhea and vomiting). Treatment related changes seen in hematology and chemistry included decreased red blood cell counts in seven of 24 dogs (four 3X and three 5X dogs), decreased hematocrit in 18 of 24 dogs (including three control dogs), dose-related neutrophilia in one 1X, two 3X and three 5X dogs, evidence of regenerative anemia in two 3X and one 5X dog. Also noted were increased BUN in two 5X dogs and decreased albumin in one 5X dog.Endoscopic changes consisted of reddening of the gastric mucosal surface covering less than 25% of the surface area. This was seen in three dogs at the recommended dose, three dogs at the 3X dose and two dogs at the 5X dose. Two control dogs exhibited reddening in conjunction with ulceration of the mucosa covering less than 25% of the surface area.Gross gastrointestinal necropsy results observed included mild discoloration of the stomach or duodenum in one dog at the 3X and in one dog at the 5X dose. Multifocal pinpoint red foci were observed in the gastric fundic mucosa in one dog at the recommended dose, and in one dog at the 5X dose.No macroscopic or microscopic renal changes were observed in any dogs receiving meloxicam in this six month study. Microscopic gastrointestinal findings were limited to one dog at the recommended dose, and two dogs at the 3X dose. Mild inflammatory mucosal infiltrate was observed in the duodenum of one dog at the recommended dose. Mild congestion of the fundic mucosa and mild myositis of the outer mural musculature of the stomach were observed in two dogs receiving the 3X dose.How Supplied:Loxicom Oral Suspension 1.5 mg/mL: 10, 32 and 100 mL bottles with small and large dosing syringes.Storage: Store at controlled room temperature 68-77°F (20-25°C). Excursions permitted between 59°F and 86°F (15°C and 30°C). Brief exposure to temperature up to 104° F (40°C) may be tolerated provided the mean kinetic temperature does not exceed 77°F (25°C); however such exposure should be minimized.Made in the UK.Manufactured by:Norbrook Laboratories LimitedNewry, BT35 6PU, Co. Down, Northern IrelandLoxicom® is a registered trademarkof Norbrook Laboratories LimitedLoxicom®(meloxicam)1.5 mg/mL Oral SuspensionmeloxicamProfessional InsertANADA 200-497, Approved by FDANon-steroidal anti-inflammatory drug for oral use in dogs onlyCaution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each milliliter of Loxicom® Oral Suspension contains meloxicam equivalent to 1.5 milligrams and sodium benzoate (1.5 milligrams) as a preservative. The chemical name for Meloxicam is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carbox-amide-1, 1-dioxide. The formulation is a yellowish viscous suspension. Indications: Loxicom Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.Dosage and Administration:Always provide client information sheet with prescription. Carefully consider the potential benefits and risk of Loxicom Oral Suspension and other treatment options before deciding to use Loxicom Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual response. Loxicom Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Loxicom Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg). The syringes are calibrated to deliver the daily maintenance dose in lbs. Because the first dose (0.2 mg/kg) is two times the amount of the daily maintenance dose (0.1 mg/kg), two syringes containing the 0.1 mg/kg dose should be administered at the first dose.Directions for Administration:Loxicom Oral Suspension is packaged with 2 sizes of dosing syringes. The small syringe is calibrated in 1-lb increments for use in dogs under 30 lbs. The large syringe is calibrated in 5-lb increments (up to 160 lbs.) and should be used for dosing dogs that are 30 lbs and over. Only administer Loxicom with theprovided syringes. The container should never be used as a dropper bottle for administration of Loxicom.Dogs under 30 lbs (13.6 kg)Shake well before use, then remove cap. Loxicom Oral Suspension can be given either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, only use the small dosing syringe. The large syringe provided should not be used to measure doses for dogs weighing less than 30 lbs (13.6 kg). For dogs under 30 lbs, use the small dosing syringe provided in the package (see dosing procedure below). The small dosing syringe fits onto the bottle and has dosing marks in 1-lb increments, designed to deliver the daily maintenance dose of 0.045 mg/lb (0.1 mg/kg). For dogs between 1 - 29 lbs, Loxicom can be given using the marks on the small dosing syringe. When using the small dosing syringe, the dog’s weight should be rounded down to the nearest 1-lb increment. Replace and tighten cap after use.Dogs 30 lbs (13.6 kg) and overShake well before use, then remove cap. Loxicom may be either mixed with food or placed directly into the mouth. Particular care should be given with regard to the accuracy of dosing. To prevent accidental overdosing of small dogs, do not use the large syringe in animals weighing less than 30 pounds.For dogs 30 lbs or greater, the large dosing syringe provided in the package should be used (see dosing procedure below). The large dosing syringe fits onto the bottle and has dosing marks in 5-lb increments (up to 160 lbs), designed to deliver the daily maintenance dose of 0.045 mg/lb (0.1 mg/kg). When using the large syringe, the dog’s weight should be rounded down to the nearest 5-lb increment. Replace and tighten cap after use.Contraindications: Dogs with known hypersensitivity to meloxicam should not receive Loxicom Oral Suspension. Do not use Loxicom Oral Suspension in cats. Acute renal failure and death have been associated with the use of meloxicam in cats.Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For oral use in dogs only.As with any NSAID all dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and periodically during administration. Owner should be advised to observe their dog for signs of potential drug toxicity and be given a client information sheet about Loxicom.Precautions: The safe use of Loxicom Oral Suspension in dogs younger than 6 months of age, dogs used for breeding, or in pregnant or lactating dogs has not been evaluated. Meloxicam is not recommended for use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient.Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or perforations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after administration of the total daily dose of Loxicom Oral Suspension, a non-NSAID or non-corticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly protein-bound drugs with Loxicom Oral Suspension has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Loxicom Oral Suspension has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.Adverse Reactions: Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. The following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have Adverse Reactions Observed During Two Field StudiesClinical Observation Meloxicam Placebo(n=157) (n=149)Vomiting 40 23Diarrhea/Soft Stool 19 11Bloody Stool 1 0Inappetance 5 1Bleeding gums after dental procedure 1 0Lethargy/Swollen Carpus 1 0Epiphora 1 0TAKE TIMEOBSERVE LABELDIRECTIONSUPDOWNShake bottle well. Push downand unscrew bottle top. Attachthe dosing syringe to the bottleby gently pushing the end ontothe top of the bottle.12Turn the bottle right way up andwith a twisting movementseparate the dosing syringefrom the bottle.Turn the bottle/syringe upside down. Pull the plunger out until the medication level corresponds to the dog's body weight in pounds.Push the plunger to empty thecontents of the syringe on food or directly in the mouth.orLoxicom 1.5mg/mL Oral SuspensionProfessional InsertScale: 100%Dimensions: 148 x 210 mmText - ≥ 6.5pt 082670I01

Cats » 5ml Bottle

Loxicom ® (meloxicam) 5 mg/mL Solution for Injection butorphanol treatment group had post-treatment anemia. All but one cat, who had a mild anemia pre-treatment (hematocrit=21% and hemoglobin=7.0 g/dL) had normal pre-treatment values. Twenty-four hours after the injection with meloxicam injection, one cat experienced pain upon palpation of the injection site. Foreign Experience: Repeated use in cats has been associated with acute renal failure and death. In studies used for the foreign approval of meloxicam injection in cats, lethargy, vomiting, inappetance, and transient pain immediately after injection were noted. Diarrhea and fecal occult blood have also been reported. Post-Approval Experience (Rev. 2009): The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system: Urinary: azotemia, elevated creatinine, elevated phosphorus, renal failure Gastrointestinal: anorexia, vomiting, diarrhea Neurologic/Behavioral: lethargy, depressio n Hematologic: anemia Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats. To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assistance, call 866-591-5777. For a complete listing of adverse reactions for meloxicam reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafteyHealth/ProductSafetyInfor mation/ucm055394.htm Information For Cat Owners: Meloxicam, like other NSAIDs, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with NSAID intolerance. Adverse reactions may include vomiting, diarrhea, lethargy, decreased appetite and behavioral changes. Cat owners should be advised when their pet has received a meloxicam injection. Cat owners should contact their veterinarian immediately if possible adverse reactions are observed. Clinical Pharmacology: Meloxicam has nearly 100% bioavailability after subcutaneous injection in cats. The terminal elimination half-life after a single dose is estimated to be approximately 15 hrs (+/-10%) in cats. Peak drug concentrations of 1.1 mcg/mL can be expected to occur within 1.5 hours following a 0.3 mg/kg subcutaneous injection in cats. The volume of distribution (Vd λ ) in cats is approximately 0.27 L/kg, with an estimated total systemic clearance of 0.013 L/hr/kg. The drug is 97% bound to feline plasma proteins. Effectiveness: Cats: The effectiveness of meloxicam injection was demonstrated in a masked field study involving a total of 138 cats representing various breeds. This study used butorphanol as an active control. Cats received either a single subcutaneous injection of 0.3 mg/kg meloxicam injection or 0.4 mg/kg butorphanol prior to onychectomy, either alone or in conjunction with surgical neutering. All cats were premedicated with acepromazine, induced with propofol and maintained on isoflurane. Pain assessment variables evaluated by veterinarians included additional pain intervention therapy, gait/lameness score, analgesia score, sedation score, general impression score, recovery score, and visual analog scale score. Additionally, a cumulative pain score, which was the summation of the analgesia, sedation, heart rate and respiratory rate scores was evaluated. A palpometer was used to quantify the pain threshold. A substantial number of cats required additional intervention in the 0-24 hour post-surgical period, with the majority of these interventions taking place within the first hour. Therefore, the percentage of cats in each group that received one or more interventions was designated as the primary assessment variable. Approximately half of the cats in each group received a pain intervention as a result of the first (time 0) post-surgical evaluation, i.e., extubation. At this point, the need to provide a pain intervention was not statistically significant between the two groups (p=0.7215). However, the median number of interventions was one per cat in the meloxicam group and two per cat in the butorphanol group and this difference was statistically significant (p=0.0021). The statistical evaluation supports the conclusion that the meloxicam test article is non-inferior to the butorphanol active control. Forty-eight of the 72 cats in the meloxicam group received one or more interventions (66.7%), and 47 of 66 cats in the butorphanol group received one or more interventions (71.2%). The number of interventions administered to the meloxicam group was less than the butorphanol group at 1, 3, 5, 8, 12, and 24 hours post-surgery.
Cats receiving meloxicam injection showed improvement in the pain assessment variables. Animal Safety: Cats: 3 Day Target Animal Safety Study - In a three day safety study, subcutaneous meloxicam injection administration to healthy cats at up to 1.5 mg/kg (5X the recommended dose) resulted in vomiting in three cats (1 of 6 control cats and 2 of 6 cats in 5X) and loose stools in four cats (2 of 6 control cats and 2 of 6 cats in 5X). Fecal occult blood was detected in ten of the twenty four cats, including two cats in the control group. This was not a dose-related event. Clinically significant hematologic changes seen included increased PT and APTT in two cats (1 of 6 control cats and 1 of 6 cats in 5X), and elevated white blood cell counts in cats having renal or GI tract lesions. Serum chemistry changes observed included decreased total protein in four of 24 cats (1 of 6 cats in 1X, 2 of 6 cats in 3X and 1 of 6 cats in 5X), concomitant increases in blood urea nitrogen (BUN) and creatinine values in 2 of 6 cats in 5X. Histological examination revealed gastrointestinal lesions ranging from inflammatory cell infiltration of the mucosa of the GI tract to erosions. Mesenteric lymphadenopathy was identified in 1 of 6 cats in 1X. Renal changes ranged from dilated medullary (2 of 6 cats in 1X, 1 of 6 cats in 3X, and 1 of 6 cats in 5X) and cortical (3 of 6 cats in 1X, 1 of 6 cats in 3X, and 3 of 6 cats in 5X) tubules and inflammation (2 of 6 cats in 1X, 2 of 6 cats in 3X, and 2 of 6 cats in 5X) or fibrosis (2 of 6 cats in 3X and 2 of 6 cats in 5X) of the interstitium to necrosis of the tip of the papilla (5 of 6 cats in 5X). Subsequent oral dosing - In a nine day study with three treatment groups, meloxicam injection was given as a single subcutaneous injection using doses of 0 mg/kg (saline injection), 0.3 mg/kg and 0.6 mg/kg on Day 0. Meloxicam oral suspension, 1.5 mg/mL or saline was then administered orally once-daily at the same respective dose (0.3 or 0.6 mg/kg) for eight consecutive days. Clinical adverse reactions included vomiting, diarrhea, lethargy, and decreased food consumption in the treated groups, and one day of diarrhea in one control cat. The gross necropsy report includes observation of reddened GI mucosa in 3 of 4 cats in the 0.3 mg/kg group and 1 of 4 cats in the 0.6 mg/kg group. All saline-treated cats were normal. By Day 9, one cat in both the 0.3 mg/kg group and the 0.6 mg/kg group died and another cat in the 0.3 mg/kg group was moribund. The cause of death for these cats could not be determined, although the pathologist reported pyloric/duodenal ulceration in the cats in 0.6 mg/kg group. The safety studies demonstrate a narrow margin of safety. Injection Site Tolerance - Histopathology of the injection sites revealed hemorrhage and inflammation, myofiber atrophy, panniculitis, fibrin deposition, and fibroblast proliferation. These findings were present in cats in all groups, with the 3X cats having the most present. No safe repeat dose has been established in cats. Storage Information: Store at controlled room temperature, 68-77°F (20-25°C). How Supplied: Loxicom 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Reference: 1 Slingsby L.S., A.E. Waterman-Pearson. Comparison between meloxicam and carprofen for postoperative analgesia after feline ovariohysterectomy. Jour of Small Anim Pract (2002)43:286-289. Made in the UK. Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland ® Loxicom is a registered trademark of Norbrook Laboratories Limited meloxicam Package Insert for Cats ANADA 200-491, Approved by FDA Non-steroidal anti-inflammatory drug for use in dogs and cats only. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information. Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each mL of this sterile product for injection contains meloxicam 5.0 mg, alcohol 15%, glycofurol 10%, poloxamer 188 5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water for injection, pH adjusted with sodium hydroxide and hydrochloric acid. Indications: Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery. Dosage and Administration: Carefully consider the potential benefits and risk of Loxicom and other treatment options before deciding to use Loxicom. Use the lowest effective dose for the shortest duration consistent with individual response. Cats: Administer a single, one-time subcutaneous dose of Loxicom ® 5 mg/mL Solution for Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg) body weight. Use of additional meloxicam or other NSAIDs is contraindicated. (See Contraindications). To
ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. Contraindications: Cats with known hypersensitivity to meloxicam should not receive Loxicom 5 mg/mL Solution for Injection. Additional doses of meloxicam or other NSAIDs in cats are contraindicated, as no safe dosage for repeated NSAID administration has been established (See Animal Safety). Do not use meloxicam in cats with pre-existing renal dysfunction. Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For subcutaneous (SQ) injectable use in cats. Do not use IV in cats. Do not administer a second dose of meloxicam. Do not follow the single, one-time dose of meloxicam with any other NSAID. Do not administer meloxicam oral suspension following the single, one-time injectable dose of meloxicam. When administering any NSAID, appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to use in dogs and cats. All cats should undergo a thorough history and physical examination before administering meloxicam. Do not repeat the single, one-time dose of meloxicam in cats. Owner should be advised to observe their cats for signs of potential drug toxicity. Precautions: The safe use of Loxicom 5 mg/mL Solution for Injection in cats younger than 4 months of age, cats used for breeding, or in pregnant or lactating queens has not been evaluated. Meloxicam is not recommended for use in cats with bleeding disorders, as safety has not been established in cats with these disorders. Safety has not been established for intravenous (IV) or intramuscular (IM) use in cats. When administering Loxicom 5 mg/mL Solution for Injection, use a syringe of appropriate size to ensure precise dosing. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Cats that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached and monitored. Anesthetic drugs may affect renal perfusion; approach concomitant use of anesthetics and NSAIDs cautiously. Appropriate monitoring procedures should be employed during all surgical procedures. The use of perioperative parenteral fluids is recommended to decrease potential renal complications when using NSAIDs. If additional pain medication is needed after the single one-time dose of meloxicam, a non-NSAID class of analgesic may be necessary. In one study 1 , one cat in each NSAID treatment group had increased intraoperative hemorrhage. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of meloxicam with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.
Consider appropriate washout times when switching from corticosteroid use to meloxicam in cats. As a single use product in cats, meloxicam should not be followed by additional NSAIDs or corticosteroids. The use of concomitantly protein-bound drugs with Loxicom 5 mg/mL Solution for Injection has not been studied in cats. Commonly used protein-bound drugs include cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Loxicom 5 mg/mL Solution for Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The effect of cyclo-oxygenase inhibition and the potential for thromboembolic occurrence or a hyper-coagulable state has not been studied. Adverse Reactions: Cats: A field study involving 138 cats was conducted. Of the 72 cats receiving meloxicam injection, six cats (8.3%) experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. Nine cats (12.5%) receiving meloxicam injection had post-treatment anemia. Pre-treatment, these cats all had hematocrit and hemoglobin values in the normal range. Four cats (6.1 %) in the 215670I01 Loxicom ® (meloxicam) 5 mg/mL Solution for Injection butorphanol treatment group had post-treatment anemia. All but one cat, who had a mild anemia pre-treatment (hematocrit=21% and hemoglobin=7.0 g/dL) had normal pre-treatment values. Twenty-four hours after the injection with meloxicam injection, one cat experienced pain upon palpation of the injection site. Foreign Experience: Repeated use in cats has been associated with acute renal failure and death. In studies used for the foreign approval of meloxicam injection in cats, lethargy, vomiting, inappetance, and transient pain immediately after injection were noted. Diarrhea and fecal occult blood have also been reported. Post-Approval Experience (Rev. 2009): The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system: Urinary: azotemia, elevated creatinine, elevated phosphorus, renal failure Gastrointestinal: anorexia, vomiting, diarrhea Neurologic/Behavioral: lethargy, depressio n Hematologic: anemia Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with the use of meloxicam in cats. To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assistance, call 866-591-5777. For a complete listing of adverse reactions for meloxicam reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafteyHealth/ProductSafetyInfor mation/ucm055394.htm Information For Cat Owners: Meloxicam, like other NSAIDs, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with NSAID intolerance. Adverse reactions may include vomiting, diarrhea, lethargy, decreased appetite and behavioral changes. Cat owners should be advised when their pet has received a meloxicam injection. Cat owners should contact their veterinarian immediately if possible adverse reactions are observed. Clinical Pharmacology: Meloxicam has nearly 100% bioavailability after subcutaneous injection in cats. The terminal elimination half-life after a single dose is estimated to be approximately 15 hrs (+/-10%) in cats. Peak drug concentrations of 1.1 mcg/mL can be expected to occur within 1.5 hours following a 0.3 mg/kg subcutaneous injection in cats. The volume of distribution (Vd λ ) in cats is approximately 0.27 L/kg, with an estimated total systemic clearance of 0.013 L/hr/kg. The drug is 97% bound to feline plasma proteins. Effectiveness: Cats: The effectiveness of meloxicam injection was demonstrated in a masked field study involving a total of 138 cats representing various breeds. This study used butorphanol as an active control. Cats received either a single subcutaneous injection of 0.3 mg/kg meloxicam injection or 0.4 mg/kg butorphanol prior to onychectomy, either alone or in conjunction with surgical neutering. All cats were premedicated with acepromazine, induced with propofol and maintained on isoflurane. Pain assessment variables evaluated by veterinarians included additional pain intervention therapy, gait/lameness score, analgesia score, sedation score, general impression score, recovery score, and visual analog scale score. Additionally, a cumulative pain score, which was the summation of the analgesia, sedation, heart rate and respiratory rate scores was evaluated. A palpometer was used to quantify the pain threshold. A substantial number of cats required additional intervention in the 0-24 hour post-surgical period, with the majority of these interventions taking place within the first hour. Therefore, the percentage of cats in each group that received one or more interventions was designated as the primary assessment variable. Approximately half of the cats in each group received a pain intervention as a result of the first (time 0) post-surgical evaluation, i.e., extubation. At this point, the need to provide a pain intervention was not statistically significant between the two groups (p=0.7215). However, the median number of interventions was one per cat in the meloxicam group and two per cat in the butorphanol group and this difference was statistically significant (p=0.0021). The statistical evaluation supports the conclusion that the meloxicam test article is non-inferior to the butorphanol active control. Forty-eight of the 72 cats in the meloxicam group received one or more interventions (66.7%), and 47 of 66 cats in the butorphanol group received one or more interventions (71.2%). The number of interventions administered to the meloxicam group was less than the butorphanol group at 1, 3, 5, 8, 12, and 24 hours post-surgery.
Cats receiving meloxicam injection showed improvement in the pain assessment variables. Animal Safety: Cats: 3 Day Target Animal Safety Study - In a three day safety study, subcutaneous meloxicam injection administration to healthy cats at up to 1.5 mg/kg (5X the recommended dose) resulted in vomiting in three cats (1 of 6 control cats and 2 of 6 cats in 5X) and loose stools in four cats (2 of 6 control cats and 2 of 6 cats in 5X). Fecal occult blood was detected in ten of the twenty four cats, including two cats in the control group. This was not a dose-related event. Clinically significant hematologic changes seen included increased PT and APTT in two cats (1 of 6 control cats and 1 of 6 cats in 5X), and elevated white blood cell counts in cats having renal or GI tract lesions. Serum chemistry changes observed included decreased total protein in four of 24 cats (1 of 6 cats in 1X, 2 of 6 cats in 3X and 1 of 6 cats in 5X), concomitant increases in blood urea nitrogen (BUN) and creatinine values in 2 of 6 cats in 5X. Histological examination revealed gastrointestinal lesions ranging from inflammatory cell infiltration of the mucosa of the GI tract to erosions. Mesenteric lymphadenopathy was identified in 1 of 6 cats in 1X. Renal changes ranged from dilated medullary (2 of 6 cats in 1X, 1 of 6 cats in 3X, and 1 of 6 cats in 5X) and cortical (3 of 6 cats in 1X, 1 of 6 cats in 3X, and 3 of 6 cats in 5X) tubules and inflammation (2 of 6 cats in 1X, 2 of 6 cats in 3X, and 2 of 6 cats in 5X) or fibrosis (2 of 6 cats in 3X and 2 of 6 cats in 5X) of the interstitium to necrosis of the tip of the papilla (5 of 6 cats in 5X). Subsequent oral dosing - In a nine day study with three treatment groups, meloxicam injection was given as a single subcutaneous injection using doses of 0 mg/kg (saline injection), 0.3 mg/kg and 0.6 mg/kg on Day 0. Meloxicam oral suspension, 1.5 mg/mL or saline was then administered orally once-daily at the same respective dose (0.3 or 0.6 mg/kg) for eight consecutive days. Clinical adverse reactions included vomiting, diarrhea, lethargy, and decreased food consumption in the treated groups, and one day of diarrhea in one control cat. The gross necropsy report includes observation of reddened GI mucosa in 3 of 4 cats in the 0.3 mg/kg group and 1 of 4 cats in the 0.6 mg/kg group. All saline-treated cats were normal. By Day 9, one cat in both the 0.3 mg/kg group and the 0.6 mg/kg group died and another cat in the 0.3 mg/kg group was moribund. The cause of death for these cats could not be determined, although the pathologist reported pyloric/duodenal ulceration in the cats in 0.6 mg/kg group. The safety studies demonstrate a narrow margin of safety. Injection Site Tolerance - Histopathology of the injection sites revealed hemorrhage and inflammation, myofiber atrophy, panniculitis, fibrin deposition, and fibroblast proliferation. These findings were present in cats in all groups, with the 3X cats having the most present. No safe repeat dose has been established in cats. Storage Information: Store at controlled room temperature, 68-77°F (20-25°C). How Supplied: Loxicom 5 mg/mL Solution for Injection: 10 mL and 20 mL vial Reference: 1 Slingsby L.S., A.E. Waterman-Pearson. Comparison between meloxicam and carprofen for postoperative analgesia after feline ovariohysterectomy. Jour of Small Anim Pract (2002)43:286-289. Made in the UK. Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland ® Loxicom is a registered trademark of Norbrook Laboratories Limited meloxicam Package Insert for Cats ANADA 200-491, Approved by FDA Non-steroidal anti-inflammatory drug for use in dogs and cats only. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information. Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each mL of this sterile product for injection contains meloxicam 5.0 mg, alcohol 15%, glycofurol 10%, poloxamer 188 5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water for injection, pH adjusted with sodium hydroxide and hydrochloric acid. Indications: Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery. Dosage and Administration: Carefully consider the potential benefits and risk of Loxicom and other treatment options before deciding to use Loxicom. Use the lowest effective dose for the shortest duration consistent with individual response. Cats: Administer a single, one-time subcutaneous dose of Loxicom ® 5 mg/mL Solution for Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg) body weight. Use of additional meloxicam or other NSAIDs is contraindicated. (See Contraindications). To
ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. Contraindications: Cats with known hypersensitivity to meloxicam should not receive Loxicom 5 mg/mL Solution for Injection. Additional doses of meloxicam or other NSAIDs in cats are contraindicated, as no safe dosage for repeated NSAID administration has been established (See Animal Safety). Do not use meloxicam in cats with pre-existing renal dysfunction. Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For subcutaneous (SQ) injectable use in cats. Do not use IV in cats. Do not administer a second dose of meloxicam. Do not follow the single, one-time dose of meloxicam with any other NSAID. Do not administer meloxicam oral suspension following the single, one-time injectable dose of meloxicam. When administering any NSAID, appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to use in dogs and cats. All cats should undergo a thorough history and physical examination before administering meloxicam. Do not repeat the single, one-time dose of meloxicam in cats. Owner should be advised to observe their cats for signs of potential drug toxicity. Precautions: The safe use of Loxicom 5 mg/mL Solution for Injection in cats younger than 4 months of age, cats used for breeding, or in pregnant or lactating queens has not been evaluated. Meloxicam is not recommended for use in cats with bleeding disorders, as safety has not been established in cats with these disorders. Safety has not been established for intravenous (IV) or intramuscular (IM) use in cats. When administering Loxicom 5 mg/mL Solution for Injection, use a syringe of appropriate size to ensure precise dosing. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Cats that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached and monitored. Anesthetic drugs may affect renal perfusion; approach concomitant use of anesthetics and NSAIDs cautiously. Appropriate monitoring procedures should be employed during all surgical procedures. The use of perioperative parenteral fluids is recommended to decrease potential renal complications when using NSAIDs. If additional pain medication is needed after the single one-time dose of meloxicam, a non-NSAID class of analgesic may be necessary. In one study 1 , one cat in each NSAID treatment group had increased intraoperative hemorrhage. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of meloxicam with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.
Consider appropriate washout times when switching from corticosteroid use to meloxicam in cats. As a single use product in cats, meloxicam should not be followed by additional NSAIDs or corticosteroids. The use of concomitantly protein-bound drugs with Loxicom 5 mg/mL Solution for Injection has not been studied in cats. Commonly used protein-bound drugs include cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Loxicom 5 mg/mL Solution for Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The effect of cyclo-oxygenase inhibition and the potential for thromboembolic occurrence or a hyper-coagulable state has not been studied. Adverse Reactions: Cats: A field study involving 138 cats was conducted. Of the 72 cats receiving meloxicam injection, six cats (8.3%) experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. Nine cats (12.5%) receiving meloxicam injection had post-treatment anemia. Pre-treatment, these cats all had hematocrit and hemoglobin values in the normal range. Four cats (6.1 %) in the 215670I01

1mg Chewable Tablets » Priced per Tablet

Loxicom 1 mg Chewable Tablets for Dogs. Loxicom 2.5 mg Chewable Tablets for Dogs

Qualitative and quantitative composition

Each chewable tablet contains:

Active substance:

Meloxicam 1 mg

Meloxicam 2.5 mg

Pharmaceutical form

Chewable tablet. Light brown oval biconvex tablet with a score line on one face and plain on the other.

The tablets can be broken into equal halves.

Clinical particulars

Target species

Dogs

Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Contraindications

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species

Special precautions for use

None.

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, a meloxicam containing oral suspension authorised for that species should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. This veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the veterinary medicinal products used previously.

Amounts to be administered and administration route

Oral use.

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight. Alternatively, therapy may be initiated with a solution for injection containing 5 mg meloxicam/ml.

Each chewable tablet contains 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog, respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal. The tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:Body weight (kg)Number of chewable tablets 1 mgNumber of chewable tablets 2.5 mgmg/kg4.0 - 7.0½0.1 - 0.137.1 - 10.010.1 - 0.1410.1 - 15.01½0.1 - 0.1515.1 - 20.020.1 - 0.1320.1 - 25.010.1 - 0.1225.1 - 35.01½0.1 - 0.1535.1 - 50.020.1 - 0.14

The use of a meloxicam containing oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of meloxicam containing oral suspension for dogs is recommended.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams),

ATC vet code: QM01AC06

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic properties

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 7.5 hours. When the veterinary medicinal product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Pharmaceutical particulars

List of excipients

- Sodium starch glycolate, type A

- Spray dried pork liver

- Lactose monohydrate

- Povidone K30

- Sucrose

- Microcrystalline cellulose and guar gum

- Microcrystalline cellulose

- Wheatgerm defatted flour

- Yeast extract (dried)

- Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.

Any unused half tablets may be returned to open blister and stored for up to 24 hours.

Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from light.

Nature and composition of immediate packaging

Blister packs of 10 tablets per strip composed of PVC/PVDC base foil and aluminuium lidding foil in cartons containing 10, 20, 100 or 500 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

Marketing Authorisation Number

Loxicom 1 mg chewable tablets for dogs:

EU/2/08/090/019 – 1 x 10 tabletes

EU/2/08/090/020 – 2 x 10 tabletes

EU/2/08/090/021 – 10 x 10 tabletes

EU/2/08/090/022 – 50 x 10 tabletes

Loxicom 2.5 mg chewable tablets for dogs:

EU/2/08/090/023 – 1 x 10 tablets

EU/2/08/090/024 – 2 x 10 tablets

EU/2/08/090/025 – 10 x 10 tablets

EU/2/08/090/026 – 50 x 10 tablets

Date of the first authorisation or date of renewal

Date of first authorisation: 10/02/2009

Date of last renewal: 12/03/2014

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

Any other information

Nil.

Legal category

2.5mg Chewable Tablets » Priced per Tablet

Loxicom 1 mg Chewable Tablets for Dogs. Loxicom 2.5 mg Chewable Tablets for Dogs

Qualitative and quantitative composition

Each chewable tablet contains:

Active substance:

Meloxicam 1 mg

Meloxicam 2.5 mg

Pharmaceutical form

Chewable tablet. Light brown oval biconvex tablet with a score line on one face and plain on the other.

The tablets can be broken into equal halves.

Clinical particulars

Target species

Dogs

Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Contraindications

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species

Special precautions for use

None.

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, a meloxicam containing oral suspension authorised for that species should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. This veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the veterinary medicinal products used previously.

Amounts to be administered and administration route

Oral use.

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight. Alternatively, therapy may be initiated with a solution for injection containing 5 mg meloxicam/ml.

Each chewable tablet contains 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog, respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal. The tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:Body weight (kg)Number of chewable tablets 1 mgNumber of chewable tablets 2.5 mgmg/kg4.0 - 7.0½0.1 - 0.137.1 - 10.010.1 - 0.1410.1 - 15.01½0.1 - 0.1515.1 - 20.020.1 - 0.1320.1 - 25.010.1 - 0.1225.1 - 35.01½0.1 - 0.1535.1 - 50.020.1 - 0.14

The use of a meloxicam containing oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of meloxicam containing oral suspension for dogs is recommended.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams),

ATC vet code: QM01AC06

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic properties

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 7.5 hours. When the veterinary medicinal product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Pharmaceutical particulars

List of excipients

- Sodium starch glycolate, type A

- Spray dried pork liver

- Lactose monohydrate

- Povidone K30

- Sucrose

- Microcrystalline cellulose and guar gum

- Microcrystalline cellulose

- Wheatgerm defatted flour

- Yeast extract (dried)

- Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.

Any unused half tablets may be returned to open blister and stored for up to 24 hours.

Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from light.

Nature and composition of immediate packaging

Blister packs of 10 tablets per strip composed of PVC/PVDC base foil and aluminuium lidding foil in cartons containing 10, 20, 100 or 500 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

United Kingdom

Marketing Authorisation Number

Loxicom 1 mg chewable tablets for dogs:

EU/2/08/090/019 – 1 x 10 tabletes

EU/2/08/090/020 – 2 x 10 tabletes

EU/2/08/090/021 – 10 x 10 tabletes

EU/2/08/090/022 – 50 x 10 tabletes

Loxicom 2.5 mg chewable tablets for dogs:

EU/2/08/090/023 – 1 x 10 tablets

EU/2/08/090/024 – 2 x 10 tablets

EU/2/08/090/025 – 10 x 10 tablets

EU/2/08/090/026 – 50 x 10 tablets

Date of the first authorisation or date of renewal

Date of first authorisation: 10/02/2009

Date of last renewal: 12/03/2014

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

Any other information

Nil.

Legal category

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews (27)

Q & A

Below are some recent questions we've received regarding Loxicom Oral for Dogs & Cats, including answers from our team.

6 July 2016 at 4:31pm

Would a joint supplement be helpful?

Louise

  • VioVet customer since 2014
  • From: Cambridgeshire, United Kingdom

My 12 yr old staffie has been prescribed loxicom for arthritis, would joint supplements such as cod liver oil or similar help him at all and can they be taken together

  • Non-Executive Director

Loxicom belongs to a group of drugs (the so called NSAIDs) which are often used alongside a joint supplement. It is widely believed that the combination is helpful, though scientific support for this is not totally conclusive. The most highly regarded joint supplements contain glucosamine, chondroitin and some other ingredients. Good examples would be Yumove and Joint Force. I would recommend you give one of these rather than cod liver oil. They need to be given for a few weeks before you can expect to see full results, because they are nutritional supplements rather than drugs, so their effects tend to take a while to build up. Some dogs do seem to respond remarkably well, others minimally, but you only find out by trying.

14 October 2015 at 5:30am

Getting prescription

Barney

How do I get a prescription &how much will my vet charge

  • Non-Executive Director

As soon as your vet has decided which medication is best for your pet, you can ask him or her to give you a written prescription for that medication. It is that piece of paper which we need a copy of before we can sell you the medication. It is entirely up to your vet how much they charge for writing it out. Most vets charge between £5 and £15, though a few vets do not charge at all. They are also able to write the prescription for just one small bottle, or multiple bottles to last you 6 months or a year if they feel the medication will be needed for that long. We can then keep a copy of the prescription and you can buy new bottles when you need them. That way you pay just one prescription fee for multiple bottles. It all depends how helpful your vet is - they vary a lot.

9 September 2015 at 4:53pm

Dose

Catherine

Is 0.1mg/kg the most a dog can have. My rotti has a osteosarcoma and is for palliative care. Currently taking 0.1mg/kg but was wondering if he can have more.

  • Non-Executive Director

Some dogs can tolerate a higher dose, others will react badly (maybe after a while as the drug builds up in the body) and suffer serious side effects (usually gastro-intestinal upset with bleeding etc, but maybe liver/kidney trouble). I am afraid that the outlook for your dog is clearly not good anyway, so you will of course just want to do what you can to make things less uncomfortable. Usually this would be achieved by adding other classes of pain-relieving medication to the Loxicom, rather than pushing the dose of Loxicom to potentially problematic levels. Your vet could prescribe other medicines to add so I would definitely do that first. (If you can get a written prescription we sell many other things very economically, but they must be prescribed by your own vet.)

25 August 2015 at 6:39pm

Side effects

Lorraine

Hello my dog has renal problems and is managed on a special diet, recently he has developed joint problems, following x-rays he was prescribed loxicom, I am concerned about the effects this drug might have on his kidneys, I am aware that unfortunately wanting to keep him pain free means we have to give him something. Is this drug particularly tough on the kidneys? Thankyou for your help.

  • Non-Executive Director

You are right to be mindful of the issues here, but there is not a perfect answer. Loxicom contains the drug meloxicam and this probably provides the best balance between good pain relief combined with minimal adverse effect on the kidneys. You should not exceed the recommended dose and if possible, judging on results, you might try to reduce the dose of Loxicom in time. Obviously talk to your own vet about this, but for many dogs in this situation, this is a perfectly reasonable choice. If your dog becomes ill in any way, especially if he goes off his food or shows vomiting or diarrhoea, then you should stop Loxicom until things are better.

23 September 2014 at 4:36pm

Why did my vet not tell me about this.

susan

my GSD just got spayed on Friday n my vet charged me £15 for 1.5 mg/ml bottle of loxicom and today I had to buy another one as she is still swollen, In future how would I go about askn for a prescription to buy online as its so much cheaper for me. ty x

  • Non-Executive Director

You can at any time ask your vet for a written prescription from him/her in order to buy medication elsewhere. Your vet will be familiar with this sort of request. He/she is obliged to give you a prescription on request if the medication is suitable, but can and normally will charge you for the document (say £10 or £15). That can mean that it is not worth buying the medication elsewhere, but it depends how helpful your vet wants to be. Some do not charge at all. Usually the system works best for animals which are on long-term medication for arthritis or heart disease etc and you can buy 6 months worth of meds on one prescription.

20 September 2014 at 1:13pm

Poor response to treatment?

how long t see improvement and

How long does it take t show improvement my dog has had injection and one dose but still squeling out in pain and cant move how long leave him before consulting vet again

  • Non-Executive Director

It sounds as if your dog might be in severe pain and the treatment is not being effective. Some causes of pain do not respond well to this drug anyway, so I think you should go back to your vet and get things re-assessed.