Glodas

Glodas

fexofenadine

Nhà sản xuất:

Glomed

Nhà tiếp thị:

Abbott
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Contents
Fexofenadine hydrochloride.
Description
60 mg tablet: Each film coated tablet contains: Fexofenadine hydrochloride 60 mg.
120 mg tablet: Each film coated tablet contains: Fexofenadine hydrochloride 120 mg.
180 mg tablet: Each film coated tablet contains: Fexofenadine hydrochloride 180 mg.
Excipients/Inactive Ingredients: 60 mg tablet: Pregelatinized starch, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, opadry pink.
120 mg tablet: Croscarmellose sodium, pregelatinized starch, microcrystalline cellulose 101, magnesium stearate, opadry AMB pink.
180 mg tablet: Lactose monohydrate, Croscarmellose sodium, Pregelatinized starch, Microcrystalline cellulose 102, Magnesium stearate, Opadry pink.
Action
Pharmacotherapeutic Group: Antihistamines for systemic use. ATC Code: R06A X26.
Pharmacology: Pharmacodynamics: Fexofenadine, an active metabolite of terfenadine, is a non-sedating antihistamine with selective peripheral H1-receptor antagonist activity. It has no significant anticholinergic and antidopaminergic properties and has no alpha 1-adrenergic or beta-adrenergic-receptor blocking effects. At the therapeutic dose, it has no sedative or other central nervous system effects. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.
Mechanism of action: Fexofenadine hydrochloride is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.
Pharmacokinetics: Absorption: 60 mg and 180 mg tablet: Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. In children, the mean Cmax value was approximately 128 ng/ml following a single dose oral administration of 30 mg Fexofenadine hydrochloride.
120 mg tablet: Fexofenadine is rapidly absorbed after oral doses with peak plasma concentrations being reached in 2 to 3 hours. Food reduces the plasma peak concentrations by 17%.
Distribution: 60 mg and 180 mg tablet: After oral administration in adults, Fexofenadine is 60-70% plasma protein bound.
120 mg tablet: It is about 60 to 70% bound to plasma proteins. Fexofenadine does not appear to cross the blood-brain barrier.
Biotransformation and elimination: 60 mg and 180 mg tablet: Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours after multiple dosing. The single and multiple dose pharmacokinetics of Fexofenadine are linear for oral doses up to 120 mg BID. A dose of 240 mg BID produced slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that Fexofenadine pharmacokinetics are practically linear at these doses between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.
120 mg tablet: About 5% of the total dose is metabolised, with only 0.5 to 1.5% of the dose undergoing hepatic biotransformation by the cytochrome P450 system to inactive metabolites, with 3.5% of the dose mostly by the intestinal mucosa to methyl ester metabolites.
Elimination half-life of about 14.4 hours has been reported although this may be prolonged in patients with renal impairment. Approximately 11 to 12% of an oral dose of fexofenadine is excreted in the urine, primarily as unchanged drug and 80% is excreted in faeces.
Indications/Uses
60 mg and 180 mg tablet: For the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years and older including sneezing, rhinorrhea, itchy nose/palate/throat.
For the treatment of chronic idiopathic urticaria in adults and children 6 years and older.
120 mg tablet: For the relief of symptoms associated with allergic rhinitis in adults and children over 12 years including sneezing, rhinorrhea, itchy nose/palate/throat.
For the treatment of chronic idiopathic urticaria in adults and children over 12 years.
Dosage/Direction for Use
Posology: Adults: 60 mg tablet: 1 tablet twice daily or 2 tablets once daily.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
180 mg tablet: 180 mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Paediatric population: Children 6 to 11 years of age: 60 mg tablet: ½ tablet twice daily.
Children under 6 years of age: 60 mg tablet: The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.
Children aged 12 years and over: 180 mg tablet: The recommended dose is 180 mg once daily taken before a meal.
Children under 12 years of age: 180 mg tablet: The efficacy and safety of fexofenadine hydrochloride 180 mg has not been studied in children under 12.
Adults and children over 12 years: 120 mg tablet: 60 mg twice daily or 120 mg once daily.
A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.
Special populations: 60 mg and 180 mg tablet: Studies in special risk groups (older people, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Method of administration: Should not be used within 2 hours of taking of antacids containing aluminium or magnesium gel.
Overdosage
Symptoms: Symptoms of fexofenadine overdose may include dizziness, drowsiness, dry mouth.
Treatment: Standard measures should be considered to remove any unabsorbed drug.
Symptomatic and supportive treatment should be indicated.
60 mg and 180 mg tablet: Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.
Contraindications
GLODAS 60/120/180 is contraindicated in patients with known hypersensitivity to any of its ingredients.
Special Precautions
Use with caution in the elderly, in patients with renal or hepatic impairment.
60 mg and 180 mg tablet: As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.
120 mg tablet: Use with caution in patients with known cardiovascular risk or prolonged QT interval.
Patients do not self-administer other antihistamine drugs when taking fexofenadine.
Fexofenadine should be discontinued at least 24 - 48 hours before intradermal antigen tests.
Excipient: 180 mg tablet: GLODAS 180 film coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: 60 mg and 180 mg tablet: On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride will produce an effect on the ability to drive or use machines. In objective tests, fexofenadine hydrochloride 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 medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.
120 mg tablet: Fexofenadine may cause drowsiness and dizziness, this susceptibility should be determined before operating a motor vehicle or machinery.
Use in pregnancy: 120 mg tablet: There are no controlled data in human pregnancy. Fexofenadine is only recommended for use during pregnancy when benefit outweighs risk.
Use in lactation: 120 mg tablet: It is not known whether fexofenadine appears in breast milk. If the drug is essential to the health, the doctor may advise to stop nursing until the treatment is finished.
Use in children: 120 mg tablet: The efficacy and safety of fexofenadine have not been studied in children under 6 years, thus should be used only if clearly needed and consult the physician.
Use In Pregnancy & Lactation
Use in pregnancy: 60 mg and 180 mg tablet: There are no adequate data from the use of Fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
120 mg tablet: There are no controlled data in human pregnancy. Fexofenadine is only recommended for use during pregnancy when benefit outweighs risk.
Use in lactation: 60 mg and 180 mg tablet: There are no data on the content of human milk after administering Fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.
120 mg tablet: It is not known whether fexofenadine appears in breast milk. If the drug is essential to the health, the doctor may advise to stop nursing until the treatment is finished.
Adverse Reactions
60 mg and 180 mg tablet: The following frequency rating has been used, when applicable: Very common (ADR ≥ 1/10); common (1/100 ≤ ADR <1/10); uncommon (1/1,000 ≤ ADR <1/100); rare (1/10,000 ≤ ADR <1/1,000); very rare (ADR < 1/10,000), not known (frequency cannot be estimated from the available data).
In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders: Common: headache, drowsiness, dizziness.
Gastrointestinal disorders: Common: nausea.
General disorders and administration site conditions: Uncommon: fatigue.
In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data): Immune system disorders: hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis.
Psychiatric disorders: insomnia, nervousness, sleep disorders or nightmares.
Cardiac disorders: tachycardia, palpitations.
Gastrointestinal disorders: diarrhoea.
Skin and subcutaneous tissue disorders: rash, urticaria, pruritus.
Inform the physician in case of any adverse reaction related to drug use.
120 mg tablet: Frequently, ADR >1/100: Nervous system: Drowsiness, fatigue, headache, insomnia, dizziness.
GI: Nausea, dyspepsia.
Others: Viral infection (cold, influenza), dysmenorrhoea, upper respiratory tract infection, coughing, fever, otitis media, sinusitis, backache.
Occasionally, 1/1000 < ADR <1/100: Nervous system: Tremor, sleep disturbances, paroniria.
GI: Dry mouth, abdominal pain.
Rarely, ADR < 1/1000: Dermatologic reactions: Rash, urticaria, pruritus.
Sensitivity reactions: Angioedema, chest tightness, dyspnea, flushing, anaphylaxis.
Inform the physician in case of any adverse reaction related to drug use.
Drug Interactions
60 mg and 180 mg tablet: Interaction studies have only been performed in adults.
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Coadministration of fexofenadine hydrochloride 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 reactions compared to the medicinal products given singly.
No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.
Fruit juices including grapefruit may reduce the bioavailability of fexofenadine and use together should be avoided.
120 mg tablet: Co-administration with ketoconazole or erythromycin may lead to an increase in the plasma levels of fexofenadine hydrochloride.
Concurrent administration with antacids containing aluminium or magnesium may decrease bioavailability of fexofenadine hydrochloride.
Fruit juices including grapefruit may reduce the bioavailability of fexofenadine and use together should be avoided.
Storage
Store at the temperature not more than 30°C, in a dry place, protect from light.
Shelf-life: 36 months from manufacturing date.
ATC Classification
R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
FC tab 60 mg (pink coloured, capsule-shaped, debossed with 'GLM' on one side, debossed with "60" and scored on other side) x 1 x 10's, 3 x 10's, 5 x 10's. 120 mg x 1 x 10's, 3 x 10's, 5 x 10's, 10 x 10's, 20 x 10's. 180 mg x 1 x 10's, 2 x 10's, 3x 10's.
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