Gemstine

Uses

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

Gemstine is also used to associated treatment for these conditions: Allergic Rhinitis (AR)

Dosage

Gemstine 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.

Ebastine may be taken with or without food.

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.

Precaution

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.

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.

Pregnancy & Breastfeeding use

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

Contraindication

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

Acute Overdose

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 Condition

Store below 25° C.

Innovators Monograph

You find simplified version here Gemstine