Description

Atosporin Oral Solution

Cyclosporine Oral Solution for Dogs and Cats

Manufactured by: Vivaldis Animal Health / Vivaldis Health and Foods Pvt. Ltd.

Dosage form: Liquid

Presentation: 

30 ml bottle with calibrated dropper

Ingredients & Composition:

Each ml contains:

Cyclosporine IP          100 mg
Absolute Alcohol IP   12% v/v
Excipients                   q.s.

Description / Action: 

Atosporin oral solution contains a potent immunosuppressive agent cyclosporin. It is commonly used in the treatment of feline allergic dermatitis, canine atopic dermatitis and perianal fistula.

Pharmacodynamics:

A powerful immunosuppressive drug, cyclosporine has been found to function by inhibiting interleukin-2 and suppressing T-helper and T-suppressor cells. Hematopoietic function or cell-mediated immunologic responses are not hampered by it. A decrease in CD4 and CD8 cells was not seen in dogs receiving 20mg/kg/day of Cyclosporine for 56 days. Cyclosporine is not neither an antihistamine nor a corticosteroid.

Pharmacokinetics:

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

Class: Immunosuppressant

Indication / Uses:

Cyclosporin is indicated for the control and treatment of

• Canine atopic dermatitis
• Feline allergic dermatitis
• Perianal fistula

Atosporin oral solution is indicated for the treatment of atopic dermatitis in dogs weigh at least 1.8 kg bodyweight.

Dogs with atopic dermatitis scratch, lick and chew the skin which can cause me red raised crusty bumps, open sores and/or hair loss. Dogs frequently get atopic dermatitis, a skin condition brought on by allergens such home dust mites or pollens that trigger an overactive immune system. The illness is persistent, chronic, and needs long term care.

Atosporin Oral solution can also be used as an aid in the treatment of perianal fistula in dogs. A perianal fistula is a syndrome of inflammation, ulceration and draining sinuses in the perianal region of the dogs. It le bought to be an immune mediated condition.

Atosporin oral solution is indicated in feline allergic dermatitis in cats manifested by excoriations (including facial and neck), eosinophilic plaques and self-induced alopecia in cats at least 6 months of age and at least 1.4 kg in body weight.

Dosage and administration:

The recommended dose rate of cyclosporine is 0.05ml/kg (5mg/kg) by mouth every 24 hours.

Atosporin oral solution is indicated for atopic dermatitis in dogs and feline allergic dermatitis in cats.

Initial daily administration of cyclosporine oral solution will continue until a sufficient clinical improvement is observed.

This will generally be the case within 4 weeks. The treatment should be discontinued if there is no improvement after the first eight weeks.

Once the clinical signs of atopic dermatitis and allergic dermatitis are satisfactorily controlled cyclosporine oral solution can then be given every other day as maintenance dose. In some cases where the clinical signs are controlled with every-other-day dosing cyclosporine oral solution may be given every 3 to 4 days Cyclosporine oral solution should be given at least 1 hour before or 2 hours after meal as bioavailability is better in fasted animals. After initial therapy dosage maybe be tapered to lowest effective dose and frequency upon consultation with your veterinarian.

Missed dosage:

Give the dose as soon as possible. Skip the missed dose, and continue with the regular schedule if it is almost time for the next dose. Never give two doses at once.

Route: Oral administration only

Species: Dogs and Cats

Over-dosage:

With a single oral dose of up to 6 times the prescribed amount, the dog showed no adverse effects beyond those that were seen with the recommended course of treatment. Since there is no specific antidote, the dog should be treated symptomatically if it exhibits overdose symptoms. After cessation of treatment signs are reversible within 2 months.

Keep out of reach of animals and children in the case of accidental ingestion of the oral solution or its contents, seek medical advice immediately and show the package insert or the label to the veterinarian.

Adverse Drug Reactions:

The occurrence of adverse reactions is common. Signs of Gastrointestinal disturbances like mucoid or soft faeces, diarrhea and vomiting may occur. GI signs are mild and transient which generally do not require the cessation of the treatment. Other undesirable effects are rare and may include lethargy, hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin reactions or change of hair coat and swollen pinne, muscle weakness or muscle cramps. These effects generally resolve spontaneously after treatment is stopped. Inform your veterinarian in case if you notice any serious effects or other effects not mentioned above. This oral solution is not for use with other immunosuppressive agents.

Side Effects:

Vomiting, diarrhea and anorexia

Warnings:

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

Not for human use. Keep this and all drugs out of reach of children. Wash hands after administration.

Contraindications:

Avoid or use with caution in pets with

• Known hypersensitivity
• Hepatic and kidney disease
• Malignant disorders
• Hypertension
• FeLV/ FIV
• Serious systemic infections or illness
• Diabetes mellitus

Do not vaccinate with live vaccine during treatment or within 2 week interval before or after treatment.

Safety: Age / Pregnancy/ Withdrawal:

Not recommended for use in lactating and pregnant animals. Your veterinarian should be advised if your dog or cat is a breeding animal so that risk or benefit assessment can be made.

Not recommended for dogs less than 1.8 kg bodyweight and cats must be at least 6 months of age and at least 1.4 kg in body weight.

Pharmaceutical precautions / Instructions: 

Store at a temperature between 15° C and 30°C, protect from light and moisture. Do not use if guarantee closure (seal) is broken or has been removed before use. In your own interest destroy bottle after use.

Keep out of reach of children & animals, away from food.

For Animal Treatment Only. Not For Human Use For Oral Administration Only.

Schedule H Prescription Drug Caution:

Not to be sold by retail without the prescription of a Registered Veterinary Practitioner.

Substitute: Ichmune C Oral Solution, VETOPIC 50 Capsules, Ciclopet Capsules and Oral Solution, Fix-etch Oral Solution,