Ebasten FT 10 mg 10's Strip Tablet

Summary:

Indications of Ebasten FT 10 mg

Ebasten FT 10 mg is indicated for the symptomatic treatment of: Seasonal and Perennial Allergic Rhinitis. Chronic Idiopathic Urticaria.

Theropeutic Class

Non-sedating antihistamines

Pharmacology

Ebasten FT 10 mg, a piperidine derivative, is a long-acting, nonsedating, second-generation histamine receptor antagonist that binds preferentially to peripheral H1 receptors. It is metabolised to active metabolite, carEbasten FT 10 mg. It has antihistaminic, antiallergic activity and prevents histamine-induced bronchoconstriction. It does not have significant sedative or antimuscarinic actions.

Dosage of Ebasten FT 10 mg

Tablet: Adults (more than 12 years of age): 10 mg (one tablet) once daily. Children (6-12 years of age): 5 mg (half tablet) once daily. Syrup: Children (2-5 years of age): 2.5 ml once daily (upto 5 ml in severe cases such as Perennial Allergic Rhinitis). Children (6-12 years of age): 5 ml once daily (upto 10 ml in severe cases such as Perennial Allergic Rhinitis). Ebasten FT 10 mg may be taken with or without food.

Administration of Ebasten FT 10 mg

Ebasten FT 10 mg may be taken with or without food.

Interaction of Ebasten FT 10 mg

Ebasten FT 10 mg in combination with either ketoconazole or erythromycin increases in plasma level of Ebasten FT 10 mg and prolonged QTc interval. Ebasten FT 10 mg does not interact with the pharmacokinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced.

Contraindications

Patients with a known hypersensitivity to Ebasten FT 10 mg or any of its ingredients.

Side Effects of Ebasten FT 10 mg

The most common side-effects are headache, dry mouth and drowsiness. Less commonly reported side effects include abdominal pain, dyspepsia, nausea and insomnia.

Pregnancy and Lactation

The safety of Ebasten FT 10 mg during pregnancy and lactation has not been established.

Precautions and Warnings

It is advisable to exercise caution when using Ebasten FT 10 mg in patients known to have the following conditions: long QT syndrome, hypokalaemia, treatment with any medicine known to produce an increase in QT interval or inhibit CYP3A4 enzyme systems such as azole antifungals and macrolide antibiotics. Use in Pregnancy and Lactation The safety of Ebasten FT 10 mg during pregnancy and lactation has not been established. Ebasten FT 10 mg should not be used during pregnancy only if clearly needed. It is not known whether Ebasten FT 10 mg is excreted in milk, therefore, Ebasten FT 10 mg should not be used during lactation.

Overdose Effects of Ebasten FT 10 mg

No clinically meaningful signs or symptoms were observed up to 100 mg given once daily. There is no specific antidote for Ebasten FT 10 mg. In case of accidental overdoses, gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.

Storage Conditions

Store below 30°C at a cool and dry place, away from light. Keep out of reach of children

Drug Classes

Non-sedating antihistamines

Mode Of Action

Ebasten FT 10 mg is a long-acting and selective H1-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remains at a constant level. Ebasten FT 10 mg is rapidly absorbed and undergoes extensive first-pass metabolism following oral administration. Ebasten FT 10 mg is almost totally converted to the pharmacologically active acid metabolite, carEbasten FT 10 mg.