Fexo120mg (Fexofenadine Hydrochloride USP)

Description

COMPOSITION
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.
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: 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.
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 grapefruit 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-

STORAGE CONDITION
Tablet: Store below 30oC, protect from light & moisture. Suspension:
Store below 30°C. Protect from light.
Keep out of children’s reach.