Fexo® 60: Each film coated tablet contains Fexofenadine Hydrochloride USP 60 mg. Fexo® 120: Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg. Fexo® 180: Each film coated tablet contains Fexofenadine Hydrochloride USP 180 mg. Fexo® Suspension: Each 5 ml suspension contains Fexofenadine Hydrochloride USP 30 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 cytochrome 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: Fexo® Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
Fexo® 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: Fexo® Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Fexo® 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.
Age group.
Fexo® Tablet.
Fexo® Oral Suspension.
In case of decreased renal function.
Adults & Children 12 years & older.
60 mg twice daily or 120 mg once daily or 180 mg once daily with water.
60 mg once daily is recommended as the starting dose.
Children 6 to 11 years.
30 mg twice daily or 60 mg once daily.
30 mg (5 ml) twice daily.
30 mg (5 ml) once daily is recommended as the starting dose.
Children 2 to 5 years.
30 mg (5 ml) twice daily.
30 mg (5 ml) once daily is recommended as the starting dose.
Children 6 months to less than 2 years.
15 mg (2.5 ml) twice daily.
15 mg (2.5 ml) once daily is recommended as the starting dose.
In case of decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
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 grapefruit may reduce the bioavailability of Fexofenadine and use together should be avoided.
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.