Composition
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. 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 include 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: Children 2 to 11 years: The recommended dose of Xofast oral suspension is 30 mg (5 ml) twice daily. A dose of 30 mg (5 ml) once daily is recommended as the starting dose in pediatric patients with decreased renal function. Chronic Idiopathic Urticaria: Children 2 to 11 years: 30 mg (5ml) Xofast oral suspension twice daily. Children 6 months to less than 2 years of age: 15 mg (2.5 ml) Xofast Oral Suspension twice daily. For pediatric patients with decreased renal function, the recommended starting doses of Xofast oral suspension are 30 mg (5 ml) once daily for patients 2 to 11 years of age and 15 mg (2.5 ml) once daily for patients 6 months to less than 2 years of age.
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
Each Bottle Contains 50 ml Suspension with a measuring cup.
