Oral suspension Yellow homogenous suspension after shaking. 2.Qualitative and Quantitive composition Each 5 ml of oral suspension contains fexofenadine hydrochloride (30 mg) 3.CLINICAL PARTICULARS 3.1 THERAPEUTIC INDICATIONS Relief of symptoms associated with urticaria from 6 months of age. Relief of symptoms associated with seasonal allergic rhinitis from 2 years of age. Relief of symptoms associated with seasonal allergic rhinitis, allergic rhinitis or urticaria. 3.2 DOSAGE AND ADMINISTRATION: Pediatrics For Allergic Rhinitis and Seasonal Allergic Rhinitis: • Children aged 2 to 11 years: 5ml (equivalent to 30mg) twice daily, when required. For Urticaria: • Children aged 6 to 23 months: 2.5ml (equivalent to 15 mg) twice daily, when required. • Children aged 2 to 5 years: 5 ml (equivalent to 30mg) twice daily, when required. • Children aged 2 to 11 years: 5ml (equivalent to 30mg) twice daily, when required. Dosage adjustment is not required in the elderly or in patients with hepatic or renal impairment. 4.CONTRAINDICATIONS: FEXODINE is contraindicated in patients with a known hypersensitivity to fexofenadine, terfenadine or any of its excipients. 5.SPECIAL WARNINGS AND PRECAUTIONS: Use in renal impairment Dosage adjustment is not required in patients with renal impairment. Use in hepatic impairment Dosage adjustment is not required in patients with hepatic impairment. Use in the elderly Dosage adjustment is not required in the elderly. Paediatric use Safety and effectiveness of fexofenadine has not been established in children under 2 years of age for allergic rhinitis and under 6 months of age for chronic idiopathic urticaria. FEXODINE suspension is intended for children from 6 months. Effects on laboratory tests No data available. 6. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION: As fexofenadine undergoes negligible hepatic biotransformation, it is unlikely to interact with other drugs through hepatic metabolism. The pharmacokinetics of fexofenadine HCl and pseudoephedrine are not altered when both drugs are co-administered. Coadministration of fexofenadine with erythromycin or ketoconazole has been found to result in a 2 - 3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly. Fexofenadine had no effect on the pharmacokinetics of erythromycin or ketoconazole. Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion respectively. No interaction between fexofenadine and omeprazole has been observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gel 15 minutes prior to fexofenadine HCl causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine HCl and aluminium and magnesium hydroxide containing antacids. 7. FERTILITY, PREGNANCY AND LACTATION Effects on fertility In rat fertility studies, dose-related reductions in implants and increases in postimplantation losses were observed at oral doses equal to or greater than 150 mg/kg of terfenadine respectively; these doses produced plasma AUC values of fexofenadine that were equal to or greater than three times the human therapeutic value respectively (based on a 60 mg twice daily fexofenadine HCl dose). Use in pregnancy Category B2. There are no studies in pregnant women exposed to fexofenadine alone or through the administration of terfenadine. Use in lactation Fexofenadine is not recommended for nursing women unless, in the physician’s judgment, the potential benefit to the patient outweighs the potential risk to the infant. There are no data on the content of human milk after administering fexofenadine. However, when terfenadine was administered to nursing mothers, fexofenadine was found to cross into human breast milk. 8. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effects of this medicine on a person’s ability to drive and use machines were not assessed as part of its registration. 9. ADVERSE EFFECTS (UNDESIRABLE EFFECTS) Fexofenadine HCl is generally well tolerated. In placebo-controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients, adverse events were comparable in fexofenadine- and placebo-treated patients. The most common adverse events reported in controlled clinical trials were headache, fatigue, dizziness or drowsiness and nausea. No apparent dose trends were revealed in adverse events. Events that have been reported during controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences less than 1% and similar to placebo, and have been reported rarely during postmarketing surveillance include: fatigue, insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis have been reported. Adverse events reported in placebo-controlled chronic idiopathic urticaria studies were similar to those reported in placebo-controlled seasonal allergic rhinitis studies. In placebo-controlled trials involving paediatric seasonal allergic rhinitis patients (6-11 years of age), adverse events were similar to those observed in trials involving seasonal allergic rhinitis patients 12 years and older. In controlled clinical trials involving paediatric patients 6 months to 5 years of age, there were no unexpected adverse events in patients treated with fexofenadine hydrochloride. As with adults, the incidence of adverse events with fexofenadine in paediatric patients was similar to placebo.
