Contraindications
- Do not use in cases of hypersensitivity to Ciclosporin or any excipients.
- Do not use in dogs less than six 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 two-week interval before or after treatment.
- Do not use in cats infected with FeLV or FIV.
Special Warnings for Each Target Species
Consideration should be given to the use of other measures and/or treatments to control moderate to severe pruritus when initiating therapy with Ciclosporin.
Special Precautions for Use in Animals
- Other causes of dermatitis (e.g., ectoparasitic infestations, flea allergic dermatitis, food allergy, bacterial/fungal infections) should be evaluated and eliminated. Treat flea infestations before and during treatment.
- Any infections should be properly treated before starting treatment. Infections during treatment are not necessarily a reason for drug withdrawal unless severe.
- Treatment may interfere with vaccination efficacy. Do not vaccinate with inactivated vaccines during treatment or within a two-week interval before or after administration. For live vaccines, see contraindications.
- Concomitant use of other immunosuppressive agents is not recommended.
- Monitor glycaemia in animals showing signs of diabetes mellitus (e.g., polyuria, polydipsia). Not recommended in diabetic animals.
- Treatment may lead to an increased incidence of clinically apparent malignancy due to decreased antitumour immune response. If lymphadenopathy is observed, further investigation is recommended, and treatment discontinued if necessary.
- Dogs: Closely monitor creatinine levels in dogs with severe renal insufficiency.
- Cats: Assess immune status for FeLV and FIV infections before treatment. Seronegative cats for T. gondii may be at risk of clinical toxoplasmosis if infected during treatment; minimise potential exposure. Stop treatment and initiate therapy in cases of clinical toxoplasmosis or other serious systemic illness. Monitor body weight; significant reduction may result in hepatic lipidosis. Discontinue treatment if persistent weight loss occurs. Efficacy and safety not assessed in cats less than 6 months of age or weighing less than 2.3 kg.
Special Precautions for Persons Administering the Product
- Accidental ingestion may cause nausea and/or vomiting. Keep out of reach of children. Do not leave unattended filled syringe in the presence of children. Dispose of uneaten medicated cat food immediately and wash the bowl. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label.
- People with known hypersensitivity to Ciclosporin should avoid contact.
- Avoid contact with eyes; rinse thoroughly with clean water if contact occurs. Wash hands and any exposed skin after use.
Adverse Reactions
- Dogs: Very commonly observed gastrointestinal disturbances (vomiting, mucoid/soft faeces, diarrhoea) are mild and transient, generally not requiring treatment cessation. Infrequently observed effects include lethargy/hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin lesions (verruciform lesions, hair coat changes), red/swollen pinnae, muscle weakness/cramps. These generally resolve after treatment stops. Very rarely, diabetes mellitus has been observed.
- Cats: Very commonly observed gastrointestinal disturbances (vomiting, diarrhoea) are generally mild and transient. Common effects include lethargy, anorexia, hypersalivation, weight loss, and lymphopenia, usually resolving after treatment cessation or dose reduction. Side effects may be severe in individual animals.
Use During Pregnancy and Lactation
The safety of the drug has not been studied in breeding male cats/dogs, nor in pregnant or lactating female cats/dogs. Use in breeding animals only upon a positive risk/benefit assessment by a veterinarian. Ciclosporin passes the placenta barrier and is excreted via milk; treatment of lactating bitches or queens is not recommended.
Interactions
- Various substances inhibit or induce enzymes involved in Ciclosporin metabolism (e.g., cytochrome P450). Dosage adjustment may be required.
- Ketoconazole is known to increase Ciclosporin blood concentration; consider doubling the treatment interval if on a daily regime.
- Macrolides (e.g., erythromycin) may increase plasma Ciclosporin levels up to twofold.
- Certain inducers of cytochrome P450, anticonvulsants, and antibiotics (e.g., trimethoprim/sulfadimidine) may lower plasma Ciclosporin concentration.
- Ciclosporin is a substrate and inhibitor of MDR1 P-glycoprotein transporter; co-administration with P-glycoprotein substrates (e.g., macrocyclic lactones like ivermectin and milbemycin) could decrease drug efflux from blood-brain barrier cells, potentially resulting in CNS toxicity.
- Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim; concomitant use is not recommended.
- Particular attention must be paid to vaccination (see Contraindications and Special precautions for use in animals).
- Concomitant use of immunosuppressive agents is not recommended.
Overdose
There is no specific antidote; treat symptomatically. Dogs at up to 5 times the recommended single oral dose showed no additional undesirable effects. With chronic overdose (4 times the recommended dose for 3+ months), hyperkeratotic areas, callous-like foot pad lesions, weight loss, hypertrichosis, increased erythrocyte sedimentation rate, and decreased eosinophil values were seen, reversible within 2 months. Cats at 3-5 times the recommended dose showed loose/soft faeces, vomiting, lymphocytosis, increased fibrinogen, activated partial thromboplastin time, slight increases in blood glucose, reversible gingival hypertrophy. ECG changes occurred rarely at 3x dose. Anorexia, recumbency, loss of skin elasticity, few/absent faeces, thin/closed eyelids at 5x dose.
