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Ichmune C 25mg

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Quick Overview


  • Immunosuppressant for treatment of Atopic Dermatitis in Dogs

  • Targets specific cells in immune system that causes allergic reaction

  • Wide distribution in tissues, concentrates in skin and relieves redness and lesions of skin

  • Available in 3 different strengths for dosing convenience as per body weight

  • Useful in other immune mediated skin diseases like Perianal fistulas

Ichmune C 25mg

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Details

 

COMPOSITION:

Each soft gelatin capsule contains:

Cyclosporine USP             100 mg

Color: Ferric Oxide Red

Each soft gelatin capsule contains:

Cyclosporine USP             50 mg

Color: Ferric Oxide Red and Ferric Oxide Black

Each soft gelatin capsule contains:

Cyclosporine USP             25 mg

Color: Ferric Oxide Red.

CATEGORY: Potent Immunosuppressive Agent

PHARMACOLOGY

PHARMACODYNAMICS:

Cyclosporine is a potent immunosuppressive agent that has been shown to work via suppression of T-helper and T-suppressor cells and inhibition of interleukin-2. It does not impair the hematopoietic system or cell-mediated immunologic responses. A decrease in CD4 and CD8 cells was not seen in dogs receiving 20 mg/kg/day of cyclosporine for 56 days. Cyclosporine is not a corticosteroid or an antihistamine.

PHARMACOKINETICS:

Cyclosporine is extensively metabolized by the cytochrome P-450 enzyme system in the liver, and to a lesser degree in the gastrointestinal tract and the kidney.

INDICATIONS:

•             Cyclosporine is indicated for the treatment of atopic dermatitis in dogs.

•             Cyclosporine can also be used as an aid in the treatment of perianal fistulae in dogs. A perianal fistula is a syndrome of inflammation, ulceration and draining sinuses in the perianal (around the anus) region of dogs, particularly German Shepherds. It is thought to be an immune-mediated condition.

•             Perianal fistula is extremely painful, malodorous and often requires surgery. Limited studies have been done on the use of cyclosporine for the treatment of perianal fistulae in dogs. However, cyclosporine may help reduce or resolve symptoms.

DOSAGE AND ADMINISTRATION:

The recommended dose rate of cyclosporine is 5 mg/kg body weight per day given according to the following scheme. Itchmune C is indicated for the treatment of atopic dermatitis in dogs. Cyclosporine capsules 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.

Bodyweight of the dog (kg)

 Ichmune C 25mg

 Ichmune C 50mg

 Ichmune C 100mg

Number of capsules given to obtain the recommended dose for atopic dermatitis

4 to <8kg

1 Capsule

 

 

8 to <15kg

 

1 Capsule

 

15 < 29kg

 

 

1 Capsule

29 < 36kg

 

1Capsule

1 Capsule

36 < 55kg

 

 

2 Capsules

Once the clinical signs of atopic dermatitis are satisfactorily controlled, cyclosporine capsule can then be given every other day as a maintenance dose. In some cases where the clinical signs are controlled with every-other-day dosing, cyclosporine capsule may be given every 3 to 4 days. Dose adjustment should only be carried out in consultation with your veterinarian. Cyclosporine capsule should be given at least 1 hour before or two hours after meal as bioavailability is better in fasted animals.

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 insert or the label to the physician.

CONTRAINDICATIONS:

Cyclosporine is contraindicated for use in dogs with a history of neoplasia.

Do not use in cases of hypersensitivity to cyclosporine or one of the excipients.

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.

WARNINGS:

Cyclosporine is a potent systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia.

Human Warnings:

Not for human use. Keep this and all drugs out of reach of children. For use only in dogs.

PREGNANCY AND LACTATION:

The safety of cyclosporine has not been studied in breeding male dogs nor in pregnant or lactating female dogs.

USE DURING LACTATION:

Cyclosporine passes the placenta barrier and is excreted via milk, therefore the treatment of lactating bitches is not recommended. Your veterinarian should be advised if your dog is a breeding animal, so that a risk/benefit assessment can be made.

ADVERSE DRUG REACTIONS:

The occurrence of adverse reactions is uncommon. Gastrointestinal disturbances such as vomiting, mucoid or soft faeces and diarrhoea may occur. They are mild and transient and generally do not require the cessation of the treatment.

Other undesirable effects are rare and may include lethargy or hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin reactions such as verruciform lesions or change of hair coat, red and swollen pinnae, muscle weakness or muscle cramps. These effects generally resolve spontaneously after treatment is stopped.

If you notice any serious effects or other effects not mentioned above, please inform your veterinarian.

OVERDOSAGE:

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.

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.

PRESENTATION: Blister of 6 capsules

STORAGE:  Store below 25°C, protect from moisture.

Do not refrigerate.

KEEP OUT OF REACH OF CHILDREN

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