Fexofenadine Fexostad 180mg Hydrochloride Telfast


Fexofenadine Hydrochloride Fexostad 180mg Fexostad 180 Pack size: Box of 1 blister x 10 film-coated tablets.
Composition: Each film-coated tablet contains fexofenadine hydrochloride 180 mg. Shelf-life: 24 months from the date of manufacturing.
Store in a well-closed container, in a dry place. Do not store above 30. Indications and Dosage & Administration: Relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Orally taken before a meal. Adults and children aged 12 years and over:
180 mg (one tablet) once daily. Children under 12 years old:
Efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12. Or as advised by physicians. Contraindications: Patients with known hypersensitivity to fexofenadine hydrochloride or to any ingredient of the drug. Adverse reactions: Common: Headache, drowsiness, dizziness. Nausea. Uncommon: Fatigue. Not known: Hypersensitivity reactions with manifestation such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis. Insomnia, nervousness, sleep disorder or nightmares (paroniria). Tachycardia, palpitations. Diarrhoea. Rash, urticarial, pruritus. Precautions: Although clinical experience generally has not revealed differences in responses between geriatric and younger patients to the drug, it should be considered that fexofenadine is substantially excreted by the kidneys and the risk of severe adverse reactions to the drug may be increased in patients with impaired renal function. Because geriatric patients may have decreased renal function, monitoring renal function may be useful and dosage should be selected with caution in these patients. Although fexofenadine hydrochloride does not share the cardiotoxic potential of its parent drug terfenadine, fexofenadine has been associated with increased QTc interval syncope, and ventricular arrhythmia in at least one susceptible patient with preexisting cardiovascular risk. Patients receiving preparations containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be instructed to take the drug only as prescribed and not to exceed the prescribed dosage. Patients also should be advised not to us other antihistamines or decongestants for self-medication. If nervousness, dizziness, or sleepiness occurs during therapy, patients should be advised to discontinue use of the fixed-combination preparation and consult a clinician. Pregnancy: There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine hydrochloride should be using during pregnancy only when the potential benefits justify the possible risks to the fetus. Lactation: Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, fexofenadine should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug. Patients may drive or perform task that require concentration while using fexofenadine. However, in order to identify sensitive people who have an unusual reaction to drugs, it is advisable to check the individual response before driving or performing complicated tasks. Fexostad 180 COMPOSITION Each Fexostad 180 film – coated tablet contains: Fexofenadine hydrochloride 180 mg Excipients q.s ^ tablet (Pregelatinized starch (Lycatab PGS), microcrystalline cellulose, pregelatinized starch (Starch 1500), croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, opadry II OY-L-28900). DESCRIPTION White, caplet – shaped, film – coated tablet, plain on both sides. PHARMACODYNAMICS Fexofenadine hydrochloride is an antihistamine with selective peripheral FI1-receptor antagonist activity. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. No sedative or other central nervous system effects were observed. PHARMACOKINETICS Fexofenadine is rapidly absorbed after oral administration with peak plasma concentrations being reached in 2 to 3 hours. It is about 60 to 70% bound to plasma proteins. About 5% of the total dose is metabolised, mostly by the intestinal mucosa, with only 0.5 to 1.5% of the dose undergoing hepatic biotransformation by the cytochrome P450 system. Elimination half-life of about 14 hours has been reported although this may be prolonged in patients with renal impairment. Excretion is mainly in the faeces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood-brain barrier. Fexofenadine is a metabolite of terfenadine and as such has been detected in breast milk after the administration of terfenadine. INDICATIONS Fexofenadine is indicated for: + Relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/ palate/ throat, itchy/ watery/ red eyes. + Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 12 years of age and older. DOSAGE AND ADMINISTRATION Fexostad 180 is administered orally. A dose of 180 mg once daily is recommended for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. CONTRAINDICATIONS Patients with known hypersensitivity to any of its ingredients. PRECAUTIONS Although clinical experience generally has not revealed differences in responses between geriatric and younger patients to the drug, it should be considered that fexofenadine is substantially excreted by the kidneys and the risk of severe adverse reactions to the drug may be increased in patients with impaired renal function. Because geriatric patients may have decreased renal function, monitoring renal function may be useful and dosage should be selected with caution in these patients. Safety and efficacy of fexofenadine hydrochloride have not been established in children younger than 6 years of age. DRUG INTERACTIONS Anti-infective agents (erythromycin, ketoconazole): No clinically important adverse effects or changes in the QT interval corrected for rate (QTc) were reported after concomitant administration of erythromycin or ketoconazole with fexofenadine. Increases in fexofenadine plasma concentrations observed during the drug interaction studies. Data from in vitro and in vivo studies in animals indicate that erythromycin and ketoconazole enhance absorption of concomitantly administered fexofenadine, possibly by affecting mechanisms of transport systems such as p-glycoprotein. Fexofenadine did not alter the pharmacokinetics of erythromycin or ketoconazole. – Antacids: Antacids containing aluminium and magnesium hydroxide have reduced the absorption of fexofenadine. Therefore, fexofenadine should not be taken closely in time with antacids containing aluminium and magnesium. USE IN PREGNANCYAND LACTATION Pregnancy: There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Lactation: Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, fexofenadine should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug. EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINES On the basis of the pharmacodynamic profile and reported adverse events it is unlikely that fexofenadine hydrochloride will produce an effect on the ability to drive or use machines. In objective tests, fexofenadine has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to drugs, it is advisable to check the individual response before driving or performing complicated tasks.
ADVERSE REACTIONS – The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride and placebo treated patients. – In rare cases, hypersensitivity reactions include urticaria, pruritus and systemic anaphylaxis have been reported. OVERDOSAGE Limited information is available on the acute toxicity of fexofenadine in humans; however, dizziness, drowsiness, and dry mouth have been reported. Single fexofenadine hydrochloride doses up to 800 mg and fexofenadine hydrochloride dosages of 690 mg twice daily for 1 month or fexofenadine hydrochloride dosages of 240 mg once daily for 1 year have been well tolerated in adults. For the treatment of fexofenadine overdosage, usual measures to remove unabsorbed drug from the GI tract, and supportive and symptomatic treatment should be initiated. Experience with terfenadine, the parent drug, indicates that fexofenadine is not effectively removed by hemodialysis. SHELF-LIFE AND STORAGE INSTRUCTIONS The expiry date of this pack is printed on the box. Do not use this pack after this date. Do not store above 30°C. Store in a dry place. Keep out of reach of children. PACK SIZES Blister of 10 tablets. Box of 1 blister or 9 blisters. Manufactured by: STADA-VN J.V. Co., Ltd. STADA Binh Duong Branch, 40 Tu Do Avenue, Vietnam-Singapre Industrial Park, Thuan An, Binh Duong Province, Vietnam Tel: (+84.274) 3767470-3767471-Fax: (+84.274) 3767469 P I140817-T

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