Fastofen 180 mg

CONTRAINDICATIONS

FASTOFEN tablets are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of FASTOFEN. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

ADVERSEREACTIONS

Seasonal Allergic Rhinitis Adverse reactions in subjects aged 12 years and older: Fexofenadine 60 mg Twice Daily :Dysmenorrhea Fexofenadine 180 mg Once Daily :Headache ,Back Pain Adverse experiences reported in pediatric subjects aged 6 years to 11 years Fexofenadine 30 mg Twice Daily : Headache, Accidental Injury, Coughing, Fever, Pain, Otitis Media, Upper Respiratory Tract Infection Adverse experiences reported in pediatric subjects with allergic rhinitis aged 6 months to 5 years of age: Vomiting, Pyrexia, Cough, Otitis media, Diarrhoea, Rhinorrhoea, Upper respiratory tract infection, Somnolence. Chronic Idiopathic Urticaria Adverse experiences reported in subjects 12 years of age and older: Fexofenadine 60 mg Twice Daily. Dyspepsia, Myalgia, Back Pain, Dizziness, Pain in extremity. Fexofenadine 180 mg Once Daily Headach, Nasopharyngitis, Upper respiratory tract infection. insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

DRUG INTERACTIONS

Drug Interaction with Erythromycin and Ketoconazole ketoconazole or erythromycin lead to increased plasma concentrations of fexofenadine ketoconazole or erythromycin co-administration enhances fexofenadine gastrointestinal absorption. ketoconazole decreases fexofenadine gastrointestinal secretion, while erythromycin may also decrease biliary excretion. Drug Interactions with Antacids administration of fexofenadine hydrochloride within 15 minutes of an aluminum and magnesium containing antacid decreased fexofenadine AUC by 41 % and Cmax by 43%. Fexofenadine hydrochloride should not be taken closely in time with aluminum and magnesium containing antacids. Interactions with Fruit Juices Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of fexofenadine. Therefore, to maximize the effects of fexofenadine, it is recommended that FASTOFEN Tablets should be taken with water.

USE IN SPECIFIC POPULATIONS

Pregnancy There are no adequate and well controlled studies in pregnant women. Fexofenadine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known if fexofenadine is excreted in human milk. There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman. Pediatric use The safety and effectiveness of fexofenadine hydrochloride in pediatric patients under 6 months of age have not been established. Geriatric use This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Over dose dizziness, drowsiness, and dry mouth have been reported. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood (up to 1.7% removed). CLINICAL

PHARMACOLOGY

Pharmacodynamics Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm and histamine release from peritoneal mast cells.

Pharmacokinetics

Absorption FASTOFEN Tablets: Fexofenadine hydrochloride was rapidly absorbed following oral administration. Distribution Fexofenadine hydrochloride is 60% to 70% bound to plasma proteins, primarily albumin and a1-acid glycoprotein. Metabolism Approximately 5% of the total dose of fexofenadine hydrochloride was eliminated by hepatic metabolism. Elimination The mean elimination half-life of fexofenadine was 14.4 hours following administration of 60 mg twice daily in healthy adult subjects. Special Populations a dose of 60 mg once daily is recommended as the starting dose in adult patients with decreased renal function. For pediatric patients with decreased renal function, the recommended starting dose of fexofenadine is 30 mg once daily for patients 2 to 11 years of age and 15 mg once daily for patients 6 months to less than 2 years of age. Hepatically Impaired. The pharmacokinetics of fexofenadine hydrochloride in subjects with hepatic disease did not differ substantially from that observed in healthy subjects. Administration of a 15 mg dose of fexofenadine hydrochloride to pediatric subjects 6 months to less than 2 years of age and a 30 mg dose to pediatric subjects 2 to 11 years of age produced exposures comparable to those seen with a dose of 60 mg administered to adults

Storage

Storage at temperature not exceeding 30ºC in dry place Package: Fastofen 60 mg : Carton box containing 1,2 or 3 PVC/AL blisters each of 15 coated tablets +pamphlet. Fastofen 120 mg: Carton box containing 1,2 or 3 PVC/AL blisters each of 15 coated tablets +pamphlet. Fastofen 180 mg: Carton box containing 1,2 or 3 PVC/AL blisters each of 10 film coated tablets +pamphlet. Produced by EL-OBOUR Modern Pharmaceutical Industries