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Presentation

\nEbaril 10 tablet: Each film-coated tablet contains Ebastine BP 10 mg. \n \nEbaril syrup: Each 5 ml syrup contains Ebastine BP 5 mg. \n \n

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Description

\nEbaril is a preparation of Ebastine. Ebastine is a long-acting and selective H1-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 administration. Ebastine is almost totally converted to the pharmacologically active acid metabolite, Carebastine. \n \n

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Indications

\nEbaril is indicated for the symptomatic treatment of: \n \n? Seasonal and perennial allergic rhinitis \n \n? Idiopathic chronic urticaria \n \n

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Dosage & Administration

\n? Children between 2 and 5 years: 2.5 ml (half teaspoonful) once daily (up to 5 ml in severe cases such as perennial allergic rhinitis) \n? Children between 6 and 11 years: 5 ml (one teaspoonful) / 5 mg (half tablet) once daily (up to 10 ml in severe cases such as perennial allergic rhinitis) \n? Adults and older children more than 11 years: 10 mg (1 tablet) or 10 ml (two teaspoonfuls) once daily. \n \nEbastine may be taken with or without food. \n \n

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Side Effects

\nThe most common side-effects are headache, dry mouth and drowsiness. Other less commonly reported side-effects include pharyngitis, abdominal pain, dyspepsia, asthenia, epistaxis, rhinitis, sinusitis, nausea and insomnia. \n \n

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Precautions

\nCaution is advised when used in hepatic impairment, renal insufficiency, QTc interval prolongation. \n \n

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Use in Pregnancy & Lactation

\nThe safety of Ebastine during pregnancy and lactation has not been established. \n \n

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Drug Interaction

\nEbastine 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. \n \n

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Over Dose

\nNo 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 over dosages, gastric lavage, monitoring of vital functions including ECG, and symptomatic treatment should be carried out. \n \n

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Commercial Pack

\nEbaril 10 tablet: Each box contains 3 blister strips of 10 tablets. \nEbaril syrup: Each box contains a bottle of 30 ml syrup and a measuring spoon. \n \n