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EBAMIN

EBASTINE BP


NAME STRENGTH PACK SIZE DOSAGE FORM
EBAMIN 10 MG 10 MG 30 S TABLET
EBAMIN 5 MG/5 ML 5 MG/5 ML 30 ML SYRUP
EBAMIN 5 MG/5 ML 5 MG/5 ML 50 ML SYRUP

Ebamine Tablet: Each film-coated tablet contains Ebastine BP 10 mg. Ebamine 30 ml & 50 ml Syrup: Each 5 ml syrup contains Ebastine BP 5 mg.

Ebastine is a long-acting and selective Hl-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remains at a constant level. Ebastine is rapidly absorbed and undergoes extensive first pass metabolism following oral administ ration . Ebastine is almost totally converted to the pharmacologically active acid metabolite, carebastine.

Ebastine is indicated for the symptomatic treatment of: • Seasonal and Perennial Allergic Rhinitis • Chronic Idiopathic Urticaria

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). Ebastine may be taken with or without food.

Patients with a known hypersensitivity to Ebastine or any of its ingredients.

Patient with cardiac risks . Concomitant use with CYP3A4 inhibitors. Severe hepatic impairment. Pregnancy and lactation.

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

Not classified

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

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

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

Ebamine Tablet: Each box contains 3 x 10 tablets in blister pack. Ebamine 30 ml & 50 ml Syrup: Each bottle contains 30 ml & 50 ml Syrup.