Composition
Each film coated tablet contains Fexofenadine Hydrochloride USP 60 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. Elimination half-life of 14 hours has been reported although this may be prolonged in patients with renal impairment. Fexofenadine does not appear to cross the blood-brain barrier.
Indications
Seasonal Allergic Rhinitis:
Xofast (Fexofenadine Hydrochloride) is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. Symptoms treated effectively including sneezing, rhinorrhea, itchy & watery nose and throat, itchy skin & red eyes.
Chronic Idiopathic Urticaria:
Xofast (Fexofenadine Hydrochloride) is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months to 11 years of age.
Dosage & Administration
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria: Adults and Children 12 years and older: The recommended dose of Xofast 60 mg twice daily or 120 mg once daily or 180 mg once daily with water . A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. Children 6 to 11 years: The recommended dose of Xofast is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.
Contraindication
Fexofenadine is contraindicated in patients with known hypersensitivity to any of its ingredients.
Warning & Precaution
Fexofenadine Hydrochloride should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency should be given a lower initial dose.
Side Effects
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
Use in Pregnancy & 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
With medicine: Fexofenadine Hydrochloride should not be taken closely in time with Aluminium and magnesium containing antacids. Co-administer of Fexofenadine Hydrochloride with either ketoconazole or erythromycin leads to increased plasma concentrations of Fexofenadine in healthy adult subjects.
With food: Fruit juices including grapefruit may reduce the bioavailability of fexofenadine and use together should be avoided
Overdose
There has been no reported case of overdose symptoms in the recommended dosage. In case of an overdose Symptomatic and supportive treatment is recommended.
Storage
Protect from light & moisture. Store in a cool & dry place below 300C temperature. Keep out of the reach of children.
Packaging
Box containing 10 X 3’s tablets in blister pack
