FFexoTM 120 : Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg.
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist
activity. Fexofenadine is rapidly absorbed after oral doses with peak plasma concentrations being
reached in 2-3 hours. It is about 60% to 70% bound to plasma proteins. About 5% of the total doses
is metabolized, mostly by the intestinal mucosa, with only 0.5% to 1.5% of the dose undergoing
hepatic biotransformation by the cyto-chrome P450 system. Elimination half-life of 14 hours has
been reported although this may be prolonged in patients with renal impairment. Excretion is
mainly in the faeces with only 10% being present in the urine. Fexofenadine does not appear to
cross the blood-brain barrier.
Seasonal Allergic Rhinitis:
FexoTM tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in
adults and children 6 years of age and older
USE IN PREGNANCY AND LACTATION
There are no adequate and well controlled studies in pregnant women. Fexofenadine should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Fexofenadine is excreted in human milk or not. Caution should be
exercised when Fexofenadine is administered to a nursing woman.
Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or
Ketoconazole. Antacid containing Aluminium and Magnesium Hydroxide reduces the absorption
of Fexofenadine. Fruit juices including grapesfruit may reduce the bioavailability of Fexofenadine
and use together should be avoided.
Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients.
DOSAGE AND ADMINISTRATION
Age group FexoTM Tablet
Adults and Children 60 mg twice daily or 120 mg once daily or 180 mg once daily
12 years and older
Children 6 to 11 30 mg twice daily or 60 mg once daily
Tablet: Store at a cool and dry place, protected from light & moisture. Suspension: Store at a cool
and dry place, protected from light. Keep out of the reach of children.