Generic

Ebastine

Indications

Ebasten is used to treat the symptoms of seasonal and permanent allergic rhinitis, as well as chronic idiopathic urticaria.

Pharmacology

Ebastine is a long-acting and selective antagonist of the H1-histamine receptor. The blockage of peripheral receptors stays stable after repeated treatment. Following oral administration, ebastine is readily absorbed and undergoes significant first-pass metabolism. Carebastine, a pharmacologically active acid metabolite, is almost completely transformed from ebastine.

Dosage & Administration

Ebasten Tablet

Adults & Children over 12 years: 10 mg (one tablet) once daily.

Ebasten® FT (Fast dissolving Tablet)

For adults and adolescents aged 12 years and older: 10 mg once daily. In cases of severe symptoms the dose may be increased to 20 mg (two Ebasten FT) once daily. Method of administration: The Ebasten FT should be placed on the tongue where it will disperse. No water or other fluid is required but if necessary, a glass of water or another beverage may drink after taking the tablet.

Ebasten Syrup

Children (2-5 years): 2.5 ml once daily (up to 5 ml in severe cases such as Perennial Allergic Rhinitis)

Children (6-12 years): 5 ml once daily (up to 10 ml in severe cases such as Perennial Allergic Rhinitis)

Ebasten can be taken with or without food.

Interaction

Concomitant use of ketoconazole, itraconazole, clarithromycin or erythromycin may increase plasma levels of Ebastine and cause QTc interval prolongation. The sedation effect of alcohol and diazepam may be enhanced.

Contraindications

Ebastine is contraindicated in patients with known hypersensitivity to Ebastine or to any of the components of this preparation.

Side Effects

The most common side effects are headache, dry mouth and drowsiness. Less commonly reported side effects include pharyngitis, abdominal pain, dyspepsia, asthenia, epistaxis, rhinitis, sinusitis, nausea and insomnia.

Pregnancy & Lactation

Pregnancy:

• Ebastine is pregnancy category B. Ebastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:

• It is not known whether Ebastine is excreted in human milk. As a precautionary measure, it is preferable to avoid the use of Ebastine during lactation.

Precautions & Warnings

Caution is advised when used in QTc interval prolongation, hypokalemia, treatment with any medicine known to produce an increase in QTc interval or inhibit CYP3A4 enzyme systems such as azole antifungals, macrolide antibiotics and a type of medicine used to treat tuberculosis (e.g. rifampicin).

Therapeutic Class

Antihistamines that don't make you sleepy.

Storage Conditions

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

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.