Ebastine is indicated for the symptomatic treatment of: Seasonal and perennial allergic rhinitis, Idiopathic chronic urticaria.
Non-sedating antihistamines
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.
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) 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) Adults and older children more than 11 years: 10 mg (1 tablet) or 10 ml (two teaspoonfuls) once daily.
Ebastine in combination with either ketoconazole or erythromycin increases 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.
Patients with a known hypersensitivity to Ebastine or any of its ingredients. It is advisable to exercise caution when using ebastine 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 ebastine during pregnancy and lactation has not been established. Ebastine should not be used during pregnancy only if clearly needed. It is not known whether ebastine is excreted in milk, therefore, ebastine should not be used during lactation.
The 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.
The safety of Ebastine during pregnancy and lactation has not been established.
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
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