MODULIS ORAL 100MG/ML 15ML | Treatment of manifestations of atopic dermatitis.

MODULES

100 mg/ml Oral Solution for Dogs

Cyclosporine for atopic dermatitis in dogs

Pharmaceutical form

Oral solution (Sol.o.)

Composition per ml:

Cyclosporine 100 mg.

Excipients: All-rac-a-tocopherol (E 307) 1 mg.

Pharmacological properties

Cyclosporine is a selective immunosuppressant that acts specifically and reversibly on T lymphocytes.

It exerts anti-inflammatory and antipruritic effects in the treatment of atopic dermatitis. It preferentially inhibits T cell activation during antigenic stimulation by reducing the production of IL-2 and other T cell-derived cytokines. It may also inhibit the antigen-presenting function of the skin's immune system. It blocks the uptake and activation of eosinophils, the production of cytokines by keratinocytes, the functions of Langerhans cells, the degranulation of the mast cell and therefore the release of histamines and proinflammatory cytokines.

It does not reduce hematopoiesis and has no effect on phagocytic cell function.

Interactions and incompatibilities

There are substances that competitively inhibit or induce the enzymes involved in the metabolism of cyclosporine, particularly cytochrome P450. Ketoconazole at a dose of 5-10 mg/kg increases the blood concentration of cyclosporine in dogs up to 5 times.

Macrolides can double the plasma level of cyclosporine.

Some inducers of cytochrome P450, anticonvulsants and antibiotics (eg trimethoprim/sulfadimidine) can reduce the plasma concentration of cyclosporine.

Cyclosporine is a substrate and an inhibitor of the MDR1 P-glycoprotein transporter. Co-administration of cyclosporine and P-glycoprotein substrates, such as macrocyclic lactones (ivermectin, milbemycin), could reduce the egress of these drugs from blood-brain barrier cells, which could lead to signs of CNS toxicity.

Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim.

Special attention should be paid to vaccinations.

Indications

Dogs: Treatment of clinical manifestations of atopic dermatitis.

Contraindications

Do not use in dogs less than 6 months of age or weighing less than 2 kg.

Do not use in cases with a history of malignancy or with progressive malignancy.

Do not vaccinate with live vaccines during treatment or within two weeks before or after treatment.

Adverse reactions

The occurrence of adverse reactions is rare.

The most frequently observed side effects are gastrointestinal disturbances such as vomiting, mucous or loose stools, and diarrhoea. They are mild and transient and generally do not require discontinuation of treatment.

Less commonly, lethargy or hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin lesions such as warty lesions or coat changes, redness and swelling of the pinnae, weakness or muscle cramps may be observed. These effects generally resolve spontaneously after discontinuation of treatment.

Diabetes mellitus has been observed very rarely, especially in West Highland White Terriers.

Route of administration

Orally.

Posology

Dogs: The average recommended dose is 5 mg/kg, equivalent to 0,5 ml of solution per 10 kg.

It should be administered daily until satisfactory clinical improvement is observed. This usually happens within 4 weeks. If no response is obtained in the first 8 weeks, treatment should be discontinued.

After the clinical symptoms of atopic dermatitis are satisfactorily controlled, the drug can be administered every 2 days as a maintenance dose.

In some cases where clinical symptoms are controlled by dosing every other day, the veterinarian may decide to give the veterinary medicinal product every 3-4 days.

Additional treatment (eg, medicated shampoos, essential fatty acids) may be considered before reducing the dosing interval.

Treatment can be discontinued when clinical symptoms are controlled. If clinical symptoms reappear, treatment should be resumed with once daily dosing and, in some cases, repeat courses of treatment may be necessary.

The veterinary medicinal product should be administered at least 2 hours before or after meals.

The drug must be administered directly into the mouth.

Special precautions

The clinical symptoms of atopic dermatitis such as itching and inflammation of the skin are not specific to this disease, so before starting treatment it is necessary to rule out other causes of dermatitis such as ectoparasitic infestations, other allergies that cause dermatological signs (eg. g., flea allergy dermatitis or food allergy) or bacterial and fungal infections. It is good practice to treat flea infestations before and during atopic dermatitis treatment.

A full clinical examination should be performed prior to treatment. Since cyclosporine inhibits T lymphocytes, and although it does not induce tumors, it may lead to an increased incidence of clinically overt malignancies.

Lymphadenopathy observed during ciclosporin treatment should be monitored regularly.

If signs of diabetes mellitus, such as polyuria or polydipsia, are observed while using the drug, the dose should be reduced or discontinued and the veterinarian should be consulted. The use of cyclosporine in diabetic dogs is not recommended.

Closely monitor creatinine levels in dogs with severe renal impairment.

Treatment with the veterinary medicinal product may interfere with the efficacy of the vaccination. In the case of inactivated vaccines, vaccination is not recommended during treatment or within two weeks before or after administration of the drug.

It is not recommended to use other immunosuppressive drugs together.

conservation mode

Keep the bottle inside the box.

Do not refrigerate.

The medicine contains fatty components of natural origin that can solidify at lower temperatures. Below 20 °C a gelatinous formation may occur, which however reverts at temperatures up to 25 °C without affecting the quality of the medicine.

Comments

With veterinary prescription

Module

See technical sheet