| Atopica | 
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. | | | | | |
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Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction 
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Soft capsules containing 10 mg, 25 mg, 50mg 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
Uses
Treatment of chronic manifestations of atopic dermatitis in dogs.
Dosage and administration
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 |
1 capsule |
|
|
| |
3 to < 4 kg |
2 capsules |
|
|
| |
4 to < 7.5 kg |
|
1 capsule |
|
| |
7.5 to < 15 kg |
|
|
1 capsule |
| |
15 to < 29 kg |
|
|
|
1 capsule | |
29 to < 36 kg |
|
|
3 capsules |
| |
36 to 55 kg |
|
|
|
2 capsules |
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.
Contra-indications, warnings, etc
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.
Undesirable effects
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.
Special precautions for use
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.
Use during pregnancy and lactation
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Interactions with other medication
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.
Pharmaceutical precautions
Do not store above 25˚C.
Keep the medicinal product in the blister pack. Keep the blister pack in the outer carton.
Disposal
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Legal category
POM-V
Packaging Quantities
Box containing 15 capsules in 3 aluminium/aluminium blister packs.
Further information
.
Pharmacological Properties
Pharmacotherapeutic group: Selective immunosuppressive agents, ATCvet code QL04A A01.
Phamacodynamic properties
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.
Pharmacokinetic particulars
Absorption:
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.
Distribution:
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.
Metabolism:
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:
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.
Marketing authorisation number
Atopica 10 mg Vm 12501/4144.
Atopica 25 mg Vm 12501/4145.
Atopica 50 mg Vm12501/4146.
Atopica 100 mg Vm 12501/4147.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Soft capsules containing 10 mg, 25 mg, 50mg 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
Uses
Treatment of chronic manifestations of atopic dermatitis in dogs.
Dosage and administration
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 |
1 capsule |
|
|
| |
3 to < 4 kg |
2 capsules |
|
|
| |
4 to < 7.5 kg |
|
1 capsule |
|
| |
7.5 to < 15 kg |
|
|
1 capsule |
| |
15 to < 29 kg |
|
|
|
1 capsule | |
29 to < 36 kg |
|
|
3 capsules |
| |
36 to 55 kg |
|
|
|
2 capsules |
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.
Contra-indications, warnings, etc
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.
Undesirable effects
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.
Special precautions for use
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.
Use during pregnancy and lactation
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Interactions with other medication
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.
Pharmaceutical precautions
Do not store above 25˚C.
Keep the medicinal product in the blister pack. Keep the blister pack in the outer carton.
Disposal
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Legal category
POM-V
Packaging Quantities
Box containing 15 capsules in 3 aluminium/aluminium blister packs.
Further information
.
Pharmacological Properties
Pharmacotherapeutic group: Selective immunosuppressive agents, ATCvet code QL04A A01.
Phamacodynamic properties
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.
Pharmacokinetic particulars
Absorption:
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.
Distribution:
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.
Metabolism:
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:
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.
Marketing authorisation number
Atopica 10 mg Vm 12501/4144.
Atopica 25 mg Vm 12501/4145.
Atopica 50 mg Vm12501/4146.
Atopica 100 mg Vm 12501/4147.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Soft capsules containing 10 mg, 25 mg, 50mg 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
Uses
Treatment of chronic manifestations of atopic dermatitis in dogs.
Dosage and administration
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 |
1 capsule |
|
|
| |
3 to < 4 kg |
2 capsules |
|
|
| |
4 to < 7.5 kg |
|
1 capsule |
|
| |
7.5 to < 15 kg |
|
|
1 capsule |
| |
15 to < 29 kg |
|
|
|
1 capsule | |
29 to < 36 kg |
|
|
3 capsules |
| |
36 to 55 kg |
|
|
|
2 capsules |
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.
Contra-indications, warnings, etc
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.
Undesirable effects
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.
Special precautions for use
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.
Use during pregnancy and lactation
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Interactions with other medication
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.
Pharmaceutical precautions
Do not store above 25˚C.
Keep the medicinal product in the blister pack. Keep the blister pack in the outer carton.
Disposal
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Legal category
POM-V
Packaging Quantities
Box containing 15 capsules in 3 aluminium/aluminium blister packs.
Further information
.
Pharmacological Properties
Pharmacotherapeutic group: Selective immunosuppressive agents, ATCvet code QL04A A01.
Phamacodynamic properties
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.
Pharmacokinetic particulars
Absorption:
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.
Distribution:
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.
Metabolism:
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:
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.
Marketing authorisation number
Atopica 10 mg Vm 12501/4144.
Atopica 25 mg Vm 12501/4145.
Atopica 50 mg Vm12501/4146.
Atopica 100 mg Vm 12501/4147.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Soft capsules containing 10 mg, 25 mg, 50mg 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
Uses
Treatment of chronic manifestations of atopic dermatitis in dogs.
Dosage and administration
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 |
1 capsule |
|
|
| |
3 to < 4 kg |
2 capsules |
|
|
| |
4 to < 7.5 kg |
|
1 capsule |
|
| |
7.5 to < 15 kg |
|
|
1 capsule |
| |
15 to < 29 kg |
|
|
|
1 capsule | |
29 to < 36 kg |
|
|
3 capsules |
| |
36 to 55 kg |
|
|
|
2 capsules |
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.
Contra-indications, warnings, etc
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.
Undesirable effects
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.
Special precautions for use
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.
Use during pregnancy and lactation
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Interactions with other medication
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.
Pharmaceutical precautions
Do not store above 25˚C.
Keep the medicinal product in the blister pack. Keep the blister pack in the outer carton.
Disposal
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
Legal category
POM-V
Packaging Quantities
Box containing 15 capsules in 3 aluminium/aluminium blister packs.
Further information
.
Pharmacological Properties
Pharmacotherapeutic group: Selective immunosuppressive agents, ATCvet code QL04A A01.
Phamacodynamic properties
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.
Pharmacokinetic particulars
Absorption:
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.
Distribution:
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.
Metabolism:
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:
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.
Marketing authorisation number
Atopica 10 mg Vm 12501/4144.
Atopica 25 mg Vm 12501/4145.
Atopica 50 mg Vm12501/4146.
Atopica 100 mg Vm 12501/4147.
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