Indications

Orotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

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Pharmacology

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Dosage & Administration

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

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Interaction

Orotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that Orotifen should therefore be avoided.

Contraindications

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

Side Effects

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

Pregnancy & Lactation

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

Precautions & Warnings

It is important to continue the previous treatment for a minimum of two weeks after starting Orotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Orotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Orotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Orotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Orotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Overdose Effects

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Therapeutic Class

Cromoglycate & related drugs

Storage Conditions

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Chemical Structure

Common Questions about Orotifen 1 mg Tablet

What is Orotifen 1 mg Tablet?

Orotifen 1 mg Tablet is an antihistamine medication and a mast cell stabilizer used to treat allergic conditions such as conjunctivitis, asthma, and urticaria (hives).

What is Orotifen 1 mg Tablet used for?

Orotifen 1 mg Tablet is indicated in bronchial asthma, rhinitis, conjunctivitis, hayfever, urticaria.

Are there any pregnancy warnings?

Asthafen 1mg tablet may be unsafe to use during pregnancy.

Are there any breast-feeding warnings?

Unknown. Human and animal studies are not available. Please consult your doctor.

Does this affect kidney function?

There is no data available. Please consult doctor before consuming the drug.

Does this affect liver function?

There is no data available. Please consult doctor before consuming the drug.

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