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Atopica is used to relieve the intense itching seen in dogs and cats suffering from atopic dermatis or atopy. This is a common condition caused by an allergy to inhaled allergens such as house dust, house dust mites and pollen grains. Atopica is often used as an alternative to steroid treatment so as to avoid the steroid side effects. Atopica works on the immune system to stop it reacting to the allergen. Atopy can be the cause of unpleasant symptoms such as constant itching, scratching and nibbling. If these are left untreated they will often continue for years, causing a significant reduction in quality of life. Atopica provides a dramatic improvement for most affected dogs and cats.
Atopica is best given on a completely empty stomach, so no food should be given for 2 hours before or after the Atopica capsules. Vomiting might sometimes occur. Once the symptoms of itching and scratching are under control, the dose can often be reduced and Atopica does not need to be given every day. Atopica is not suitable for very young animals. If skin infection is present as a complication of the atopic dermatitis, then this should be treated first.
Soft capsules containing 10 mg, 25 mg, 50 mg or 100 mg cyclosporine A. The capsules bear the imprint 'NVR' and are labelled with the amount of active ingredient in milligrams. They are coloured as follows:
Atopica 10 mg: yellow-white oval capsule
Atopica 25 mg: blue-grey oval capsule
Atopica 50 mg: yellow-white oblong capsule
Atopica 100 mg: blue-grey oblong capsule
Treatment of chronic manifestations of atopic dermatitis in dogs.
The mean recommended dose of cyclosporine is 5 mg/kg body weight according to the tabulated dosage scheme.
Atopica dosage scheme:
Body weight of dog
Number of capsules given to obtain recommended dose
Atopica 10 mg
Atopica 25 mg
Atopica 50 mg
Atopica 100 mg
2 to < 3 kg
3 to < 4 kg
4 to < 7.5 kg
7.5 to < 15 kg
15 to < 29 kg
29 to < 36 kg
36 to 55 kg
Atopica will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4 weeks. If no response is obtained within the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the preparation can then be given every other day as a maintenance dose. The veterinary surgeon should perform a clinical assessment at regular intervals and adjust the frequency of administration to the clinical response obtained.
In some cases where the clinical signs are controlled with every-other-day dosing, the veterinary surgeon can decide to give Atopica every 3 to 4 days.
Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and in certain cases repeated treatment courses may be required.
Atopica should be given at least 2 hours before or after feeding. Insert the capsule directly into the dog’s mouth.
Do not use in cases of hypersensitivity to cyclosporine or one of the excipients.
Do not use in dogs less than 6 months of age or less than 2 kg in weight.
Do not use in cases with a history of malignant disorders or progressive malignant disorders.
Do not vaccinate with a live vaccine during treatment or within a 2-week interval before or after treatment.
The occurrence of adverse reactions is uncommon.
The most frequently observed undesirable effects are gastrointestinal disturbances such as vomiting, mucoid or soft faeces and diarrhoea. They are mild and transient and generally do not require the cessation of the treatment. Other undesirable effects may be observed infrequently: anorexia, mild to moderate gingival hyperplasia, verruciform lesions of the skin or change of hair coat, red and swollen pinnae, muscle weakness or muscle cramps. These effects resolve spontaneously after treatment is stopped.
Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations, other allergies which cause dermatological signs (e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should be ruled out before treatment is started. It is good practice to treat flea infestations before and during treatment of atopic dermatitis.
It is recommended to clear bacterial and fungal infections before administering Atopica. However, infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe.
A complete clinical examination should be performed before treatment. As cyclosporine inhibits T-lymphocytes and though it does not induce tumours, it may lead to increased incidences of clinically apparent malignancy. Lymphadenopathy observed on treatment with cyclosporine should be regularly monitored.
In laboratory animals, cyclosporine is liable to affect the circulating levels of insulin and to cause an increase in glycaemia. In the presence of suggestive signs of diabetes mellitus, the effect of treatment on glycaemia must be monitored. The use of cyclosporine is not recommended in diabetic dogs.
Closely monitor creatinine levels in dogs with severe renal insufficiency.
Particular attention must be paid to vaccination. Treatment with Atopica may interfere with vaccination efficacy. In the case of inactivated vaccines, it is not recommended to vaccinate during treatment or within a 2-week interval before or after administration of the product.
It is not recommended to use other immunosuppressive agents concomitantly.
The safety of the drug has neither been studied in breeding male dogs nor in pregnant or lactating female dogs. In the absence of such studies in the dog, it is recommended to use the drug in breeding dogs only upon a positive risk/benefit assessment by the veterinary surgeon. Cyclosporine passes the placenta barrier and is excreted via milk. Therefore the treatment of lactating bitches is not recommended.
In laboratory animals, at doses which induce maternal toxicity (rats at 30mg/kg bw and rabbits at 100mg/kg bw) ciclosporin was embryo- and fetotoxic, as indicated by increased pre- and postnatal mortality and reduced foetal weight together with skeletal retardations. In the well-tolerated dose range (rats at up to 17mg/kg bw and rabbits at up to 30 mg/kg bw ciclosporin was without embryolethal or teratogenic effects.
No undersirable effects beyond those that were seen under recommended treatment have been observed in the dog with a single oral dose of up to 6 times of what is recommended. In addition to what was seen under recommended dosage, the following adverse reactions were seen in case of overdose for 3 months or more at 4 times the mean recommended dosage: hyperkeratotic areas especially on the pinnae, callous-like lesions of the foot pads, weight loss or reduced weight gain, hypertrichosis, increased erythrocyte sedimentation rate, decreased eosinophil values. Frequency and severity of these signs are dose dependent.
There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically. The signs are reversible within 2 months following cessation of treatment.
Various substances are known to competitively inhibit or induce the enzymes involved in the metabolism of cyclosporine, in particular cytochrome P450 (CYP 3A 4). In certain clinically justified cases, an adjustment of the dosage of Atopica may be required. Ketoconazole at 5-10 mg/kg is known to increase the blood concentration of cyclosporine in dogs up to five-fold, which is considered to be clinically relevant. During concomitant use of ketoconazole and cyclosporine the veterinary surgeon should consider as a practical measure to halve the dose or to double the treatment interval if the dog is on a daily treatment regime.
Macrolides such as erythromycin may increase the plasma levels of cyclosporine up to two-fold.
Certain inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/sulfadimidine) may lower the plasma concentration of cyclosporine.
Cyclosporine is a substrate and an inhibitor of the MDR 1 P-glycoprotein transporter. Therefore, the co-administration of cyclosporine with P-glycoprotein substrates such as macrocyclic lactones (e.g. ivermectin and milbemycin) could decrease the efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
Cyclosporine can increase the nephrotoxicity of animoglycoside antibiotics and trimethoprim. The concomitant use of cyclosporine is not recommended with these active ingredients.
Do not store above 25°C.
Keep the medicinal product in the blister pack. Keep the blister pack in the outer carton.
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Box containing 15 capsules in 3 aluminium/aluminium blister packs.
Pharmacotherapeutic group: Selective immunosuppressive agents, ATCvet code QL04A A01.
Ciclosporine (also known as cyclosporin, cyclosprine, cyclosporine A, CsA) is a selective immunosuppressor. It is a cyclic polypeptide consisting of 11 amino acids, has a molecular weight of 1203 daltons and acts specifically and reversibly on T lymphocytes.
Ciclosporin exerts anti-inflammatory and antipruritic effects in the treatment of atopic dermatitis. Ciclosporin has been shown to preferentially inhibit the activation of T-lymphocytes on antigenic stimulation by impairing the production of IL-2 and other T-cell derived cytokines. Ciclosporin also has the capacity to inhibit the antigen-presenting function on the skin immune system. It likewise blocks the recruitment and activation of eosinophils, the production of cytokines by keratinocytes, the functions of Langerhans cells, the degranulation of mast cells and therefore the release of histamine and pro-inflammatory cytokines.
Ciclosporin does not depress haematopoiesis and has no effect on the function of phagocytic cells.
The bioavailability of ciclosporin is about 35%. The peak plasma concentration is reached within 1 to 2 hours. The bioavailability is better and less subject to individual variations if ciclosporin is administered to fasted animals rather than at mealtimes.
In dog, the volume of distribution is about 7.8L/kg. Ciclosporin is widely distributed to all tissues. Following repeated daily administration to dogs ciclosporin concentration in the skin is several times higher than in blood.
Ciclosporin is metabolised mainly in the liver by cytochrome P450 (CYP 3A 4), but also in the intestine. Metabolism takes place essentially in the form of hydroxylation and demethylation, leading to metabolites with little or no activity. Unchanged ciclosporin represents about 25% of circulating blood concentrations in the course of the first 24 hours.
Elimination is mainly via the faeces. Only 10% is excreted in the urine, mostly in the form of metabolities. No significant accumulation was observed in blood of dogs treated for one year.
Atopica 10 mg Vm 12501/4144.
Atopica 25 mg Vm 12501/4145.
Atopica 50 mg Vm12501/4146.
Atopica 100 mg Vm 12501/4147.
Atopica 100mg/ml cyclosporine A oral solution for cats presented in a multi-dose amber glass vial containing 5ml or 17ml oral solution closed with a rubber stopper and sealed with a screw cap. One vial and a dispenser set (consisting of a dip tube and a 1ml syringe) packed in a cardboard box.
Symptomatic treatment of chronic manifestations of allergic dermatitis in cats.
The recommended dose of ciclosporin is 7 mg/kg body weight (0.07 ml of oral solution per kg). The frequency of administration should subsequently be reduced depending on the response.
Atopica oral solution should initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4-8 weeks. If an unsatisfactory response is obtained within the first 8 weeks, the diagnosis and treatment should be re-evaluated.
Once the clinical signs of allergic dermatitis are satisfactorily controlled, the product can then be given every second day. In some cases where the clinical signs are controlled with every second day dosing, the veterinary surgeon can decide to give the product every 3 to 4 days.
Atopica oral solution can be given either mixed with food or directly into the mouth. If given with food, the solution should be mixed with a small amount of food, preferably after a sufficient period of fasting to ensure complete consumption by the cat. When given directly into the mouth with the syringe, insert the syringe directly into the cat's mouth and deliver the entire dose. In the case the cat only partially consumes the product mixed with food, administration of the product with the syringe should be resumed only the next day.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats infected with FeLV or FIV.
Do not use in cats with a history of malignant disorders or suspected malignancy.
Do not vaccinate with a live vaccine during treatment or with a two week interval before or after treatment.
Special precautions for use in animals
Allergic dermatitis in cats can have various manifestations, including eosinophillic plaque, head and neck excoriation, symmetrical alopecia and/or miliary dermatitis. Clinical signs of allergic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations should be evaluated and eliminated. It is good practice to treat flea infestations before and during treatment of allergic dermatitis. A complete clinical examination should be performed prior to treatment. The immune status of cats to FeLV and FIV infections should be assessed before treatment.
While ciclosporin does not induce tumours, it does inhibit T-lymphocytes and therefore treatment with ciclosporin may lead to an increased incidence of clinically apparent malignancy. If lymphadenopathy is observed in cats while on treatment with ciclosporin, the animal should be evaluated for clinical disease and treatment discontinued if necessary.
Ciclosporin may cause elevated levels of blood glucose. The use of ciclosporin is not recommended in diabetic cats.
The efficacy and safety of ciclosporin has neither been assessed in cats less than 6 months of age nor weighing less than 2.3kg.
Cats that are seronegative for T. gondii may be at risk of developing clinical toxoplasmosis if they become infected while under treatment. In rare cases this can be fatal. Potential exposure of seronegative cats to Toxoplasma should therefore be avoided (eg keep indoors, avoid raw meat or scavenging). Ciclosporin was shown to not increase T. gondii oocyte shedding in a controlled laboratory study. In cases of clinical toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin and initiate appropriate therapy. Any infections should be properly treated before initiation of treatment. Infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe.
Treatment with Atopica oral solution may result in decreased immune response to vaccination. It is recommended not to vaccinate during treatment or within a two-week interval before or after administration of the product.
Clinical studies in cats have shown that decreased appetite and weight loss may occur during ciclosporin treatment. Monitoring of body weight is recommended. In the event of persistent, progressive weight loss a complete clinical examination should be performed and treatment discontinued.
It is not recommended to use immunosuppressive agents concomitantly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after administration. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to ciclosporin should avoid contact with the product.
Adverse reactions (frequency and seriousness)
The most frequently observed undesirable effects are gastrointestinal disturbances such as vomiting and diarrhoea. These are generally mild and transient and do not require the cessation of the treatment. Other undesirable effects observed in clinical studies included: lethargy, anorexia, hypersalivation, weight loss and lymphopaenia. These effects generally resolve spontaneously after treatment is stopped or following a decrease in dosing frequency. Side affects may be severe in individual animals.
Use during pregnancy, lactation or lay
The safety of the drug has neither been studied in male reproducing cats nor in pregnant or lactating female cats. In the absence of such studies in the cat, it is only recommended to use the drug in reproducing cats only upon a positive risk/benefit assessment by the veterinary surgeon.
In laboratory animals, at doses which induce maternal toxicity (rats at 30mg/kg BW and rabbits at 100mg/kg BW) ciclosporin was embryo-and foetotoxic, as indicated by increased pre- and postnatal mortality and reduced foetal weight together with skeletal retardations. In the well-tolerated dose range (rats at up to 17 mg/kg BW and rabbits at up to 30mg/kg BW) ciclosporin was without embryolethal or teratogenic effects. In laboratory animals ciclosporin passes the placenta barrier and is excreted via milk. Therefore treatment in lactating cats is not recommended.
Interaction with other medicinal products and other forms of interaction
Various substances are known to competitively inhibit or induce the enzymes involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP 3A 4). The compound class of azoles e.g. ketoconazole is know to increase the blood concentration of ciclosporin in cats, which is considered to be clinically relevant. Macrolides such as erythromycin may increase the plasma levels of ciclosporin up to twofold. Certain inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDRI P-glycoprotein transporter. Therefore, the co-administration of ciclosporin with P-glycoprotein substrates such as macrocyclic lactones could decrease the efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity. In clinical studies with cats treated with ciclosporin and selamectin or milbemycin, there did not appear to be an association between these drugs' concomitant use and neurotoxicity. Ciclosporin can increase the nephrotoxocity of aminoglycoside antibiotics and trimethoprim, the concomitant use of ciclosporin with these antibiotics is not recommended.
Particular attention must be paid to vaccination (see section "Special precautions for use").
Once broached, do not store above 30°C or below 20° C. Shelf-life of Atopica oral solution as packaged for sale; 36 months. Shelf-life after first opening the immediate packaging; 70 days, keep the bottle in the outer carton.
The product contains fat components from natural origin which can become solid at lower temperatures. A jelly like formulation may occur below 20°C which is reversible at temperatures up to 30°C. Minor flakes or a slight sediment may still be observed. However, this does neither affect the dosing nor the efficacy and safety of the product.
Disposal - Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Cardboard box with one multi-dose amber glass vial containing 5 ml or 17 ml oral solution.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, immunosuppressants, Calcineurin inhibitors, ciclosporin.
ATCvet code: QL04AD01.
Ciclosporin (also known as cyclosporin, cyclosporine, cyclosporine A, CsA) is a selective immunosuppressor. It is a cyclic polypeptide consisting of 11 amino acids, has a molecular weight of 1203 daltons and acts specifically and reversibly on T lymphocytes.
Ciclosporin exerts anti-inflammatory and antipruritic effects in the treatment of allergic dermatitis. Ciclosporin has been shown to preferentially inhibit the activation of T-lymphocytes on antigenic stimulation by impairing the production of IL-2 and other T-cell derived cytokines. Ciclosporin also has the capacity to inhibit the antigen-presenting function of the skin immune system. It likewise blocks the recruitment and activation of eosinophils, the production of cytokines by keratinocytes, the function of Langerhans cells, the degranulation of mast cells and therefore the release of histamine and pro-inflammatory cytokines.
Ciclosporin does not depress haematopoiesis and has no effect on the function of phagocytic cells.
The bioavailability of ciclosporin administered to cats fasted for 24 hrs (either directly into the mouth or mixed with a small amount of food) or just after feeding was 29% and 23% respectively. The peak plasma concentration is generally reached within 1 to 2 hours when given to fasted cats or mixed with food. The absorption can be delayed by several hours when given after feeding.
In spite of differences in the pharmacokinetics of the drug given mixed with food or directly into the mouth of fed cats, it has been shown that the same clinical response is obtained.
In cats, the volume of distribution at steady state is about 3.3 l/kg. Ciclosporin is widely distributed to all tissues, including the skin.
Ciclosporin is metabolised mainly in the liver by cytochrome P450 (CYP 3A 4), but also in the intestine. Metabolism takes place essentially in the form of hydroxylation and demethylation, leading to metabolites with little or no activity.
Elimination is mainly via the faeces. A small proportion of the administered dose is excreted through urine as inactive metabolites.
A slight bioaccumulation related to the long half life of the drug (approximately 24h) is observed with repeated dosing. The steady state is reached within a week.
In the cat, there are large inter-individual variations in plasma concentrations. At the recommended dosage, ciclosporin plasma concentrations are not predictive of the clinical response, therefore monitoring of blood levels is not recommended.
The steady state is reached within a week, with a bioaccumulation factor in the range of 2 to 3.
List of excipients
Propylene glycol (E-1520)
Novartis Animal Health UK Ltd
c/o Lilly House
Atopica 100mg/ml 17ML
Atopica 100mg/ml 5ML
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