FexoTM 60: Each film coated tablet contains Fexofenadine Hydrochloride USP 60 mg. FFexoTM 120: Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg. FexoTM 180: Each film coated tablet contains Fexofenadine Hydrochloride USP 180 mg. FexoTM Suspension: Each 5 ml suspension contains Fexofenadine Hydrochloride USP 30 mg. PHARMACOLOGY 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.INDICATION 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. FexoTM Oral Suspension is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children 2 to 11 years of age. Symptoms to treat effectively: sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Chronic Idiopathic Urticaria: FexoTM tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. FexoTM Oral Suspension is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 11 years of age. Fexofenadine Hydrochloride significantly reduces pruritus and the number of wheals. 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. DRUG INTERACTION 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. CONTRAINDICATION Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients. DOSAGE AND ADMINISTRATION In case of decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. STORAGE CONDITION 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.
HOW SUPPLIED FexoTM 60: Each box contains 5 x 10 tablets in blister pack. FexoTM 120: Each box contains 5 x 10 tablets in blister pack. FexoTM 180: Each box contains 3 x 10 tablets in blister pack. FexoTM Susupension: Each bottle contains 50 ml suspension and calibrated dropper & measuring cup.