- Seasonal Allergic Rhinitis
- Chronic Idiopathic Urticaria
Rynofex 120 tablet: Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg.
Rynofex 180 tablet: Each film coated tablet contains Fexofenadine Hydrochloride USP 180 mg.
Therapeutic Class: Antihistamine
Pharmacology : 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 are 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 Fexofenadine is 14 hours has been reported although this may be prolonged in patients with renal impairment. Excretion is mainly in the feces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood-brain barrier.
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity.
Dose and Administration: Adults and children of 12 years and older: The recommended dose of Rynofex is 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.
Contraindication: Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients.
Warning & Precaution: Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness.
a) Common: The most common side-effects include drowsiness, nausea, dizziness, dysmenorrhea, headache, fatigue.
b) Rare: Rare side effect of Fexofenadine is throat irritation.
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.
Use in children & adolescents: Rynofex 120 mg tablet & Rynofex 180 mg tablet are not indicated for the children below 12 years of age.
a) With medicine: Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or Ketoconazole. Antacid containing Aluminum and Magnesium Hydroxide reduces the absorption of Fexofenadine.
b) With Food and others: Fruit juices including grapes fruit may reduce the bioavailability of Fexofenadine and use together should be avoided. Overdose: There is no clinical experience with Fexofenadine overdose. Symptomatic and supportive treatment is recommended.
Storage: Store below 30°C, protect from light & moisture. Keep away from the reach of the children.
Rynofex 120 tablet: Each box contains 3 x 10’s tablets in Alu-PVC blister pack.
Rynofex 180 tablet: Each box contains 3 x 10’s tablets in Alu-PVC blister pack.
120 mg, 180 mg