Atopica Soft Capsules for Dogs POM-V

Product Description

Target species

Dogs

Indications for use, specifying the target species

Treatment of chronic manifestations of atopic dermatitis in dogs.

Contraindications

Do not use in cases of hypersensitivity to ciclosporin or any of the excipients.

For all capsule strengths, 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. (see also “Special precautions for use” and “Interaction with other medicinal products and other forms of interaction”).

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

i) Special precautions for use in animals

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 The veterinary medicinal product. 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 ciclosporin inhibits T-lymphocytes and though it does not induce tumors, it may lead to increased incidences of clinically apparent malignancy. Lymphadenopathy observed on treatment with ciclosporin should be regularly monitored.

In laboratory animals, ciclosporin 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. If signs of diabetes mellitus are observed following the use of the product, e.g. polyuria or polydipsia, the dose should be tapered or discontinued and veterinary care sought. The use of ciclosporin 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 the veterinary medicinal product may interfere with vaccination efficacy. In the case of inactivated vaccines, it is not recommended to vaccinate during treatment or within a two-week interval before or after administration of the product. For live vaccines see “Contraindications”.

It is not recommended to use other immunosuppressive agents concomitantly.

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

Wash hands after administration.

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

Adverse reactions (frequency and seriousness)

1generally mild and transient and do not require the cessation of the treatment

2generally resolve spontaneously after treatment is stopped

3mild to moderate

4mainly in West Highland White Terriers

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Use during pregnancy, lactation or lay

In laboratory animals, at doses which induce maternal toxicity (rats at 30 mg/kg bw and rabbits at 100 mg/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 17 mg/kg bw and rabbits at up to 30 mg/kg bw) ciclosporin was without embryolethal or teratogenic effects. 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 veterinarian. Ciclosporin passes the placenta barrier and is excreted via milk. Therefore the treatment of lactating bitches is not recommended.

Interactions 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). In certain clinically justified cases, an adjustment of the dosage of the veterinary medicinal product. may be required. Ketoconazole at 5-10 mg/kg is known to increase the blood concentration of ciclosporin in dogs up to fivefold, which is considered to be clinically relevant. During concomitant use of ketoconazole and ciclosporin the veterinarian should consider as a practical measure to double the treatment interval if the dog is on a daily treatment regime.

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 MDR1 P-glycoprotein transporter. Therefore, the co-administration of ciclosporin 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.

Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim. The concomitant use of ciclosporin is not recommended with these active ingredients.

In dogs, no toxicological interactions between ciclosporin and prednisolone (at anti-inflammatory doses) are expected.

Particular attention must be paid to vaccination (see “Contraindications” and “Special precautions for use”).

Amount(s) to be administered and administration route

Oral use.

To ensure a correct dosage, body weight should be determined as accurately as possible.

The mean recommended dose of ciclosporin is 5 mg/kg body weight according to the following scheme.

The veterinary medicinal product 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 veterinary medicinal product can then be given every other day as a maintenance dose. The veterinarian 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 veterinarian can decide to give the veterinary medicinal product 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.

The veterinary medicinal product should be given at least 2 hours before or after feeding. Insert the capsule directly into the dog’s mouth.

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

No undesirable 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.

FULL DATA SHEET

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