Tablet Manufacturer/Distributor: ACI Limited Generic Name: Fexofenadine Hydrochloride 120 mg Tablet
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Indications
Ritch is indicated for relief of symptoms associated with seasonal allergic rhinitides such as sneezing, rhinorrhea, pruritus, and lacrimation Perennial allergic rhinitis Urticaria.
Pharmacology
Fexofenadine Hydrochloride is an antihistamine that works by blocking peripheral H1 receptors. After oral administration, it is rapidly absorbed and reaches maximal plasma concentration in 2-3 hours. It doesn't appear to be able to pass through the blood-brain barrier.
Dosage & administration
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 2 to 11 years
Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 6 months to less than 2 years:
Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
Children from 2 to 11 years:
Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Interaction
Plasma concentration of Fexofenadine Hydrochloride has been increased when given with erythromycin or ketoconazole. Aluminum and magnesium hydroxide-containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Contraindications
Fexofenadine is contraindicated in patients with a known hypersensitivity to Fexofenadine or any of its ingredients.
Side Effects
Fexofenadine is generally well tolerated. The most common side effects are headache, fatigue, dizziness or drowsiness, and nausea. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions such as angioedema, dyspnoea, chest tightness, flushing, and systemic anaphylaxis have been reported.
Pregnancy and Lactation
Fexofenadine is pregnancy category B2. There are no adequate and well-controlled studies on pregnant women exposed to Fexofenadine alone or through the administration of Terfenadine. Fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Fexofenadine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fexofenadine is administered to a nursing woman.
Precautions & Warnings
Studies in the elderly, patients with hepatic impairment, and patients with cardiac disease exposed to Fexofenadine through administration of Terfenadine showed no statistically significant differences in pharmacokinetic parameters for Fexofenadine when compares to those pharmacokinetic parameters in healthy individuals. There is only limited data on the elderly and really or hepatically impaired patients. Fexofenadine should be administered with care in these special groups. Fexofenadine causes drowsiness less than other antihistamines; therefore caution should be advised during driving or operating potentially dangerous machinery.
Storage conditions
Store in a cool and dry place. Protect from light. Keep away from the reach of children.
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