Ebatin Tablet 10 mg

৳ 8.00

Popular Pharmaceuticals Ltd.

Category:

Ebastine

Indications

Ebastine is indicated for the symptomatic treatment of: Seasonal and perennial allergic rhinitis, Idiopathic chronic urticaria.

Therapeutic Class

Non-sedating antihistamines

Pharmacology

Ebastine, 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, carebastine. It has antihistaminic, antiallergic activity and prevents histamine-induced bronchoconstriction. It does not have significant sedative or antimuscarinic actions.

Dosage

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.

Administration

Ebastine may be taken with or without food.

Interaction

The interaction of ebastine in combination with either ketoconazole or erythromycin (both known to prolong the QTc interval) has been evaluated. A significant pharmacokinetic and pharmacodynamic interaction has been observed with this combination; an 18-19 msec (4.7% – 5%) increase in QTc has been reported with either combination. Ebastine does not interact with the kinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced. When ebastine is administered with food, there is a 1.5 to 2.0 fold increase in the plasma levels and the AUC of the main active acid metabolite of ebastine. This increase does not alter the Tmax. The administration of ebastine with food does not cause a modification in its clinical effect.

Contraindications

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

Side Effects

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.

Pregnancy & Lactation

The safety of Ebastine during pregnancy and lactation has not been established.

Precautions

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.

Overdose Effects

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

Storage Conditions

Store below 25° C.

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