Fixal Tablet 180mg
10 tablets
Fixal
Fexofenadine Hydrochloride USP
Description Fexofenadine Hydrochloride (Fizal) is an Antihistamine with selective percheral Hi-receptor antagonist activity. Fexofenadine does not
appear to cross the blood brain bamer Mode of action: Fexofenadine (Fixal) blocks H-receptor & thus prevents activation of cells by Histamine in GI tract, large blood vessels bronchial smooth muscle. This leads to relief of the allergic symptoms. Unlike most other arthistamines, Fexofenadine does not cross Blood Brain Barrier,
and therefore, does not cause drowsiness
Pharmacokinetics: Fexofenadine (Fixal") is rapidly absorbed after oral about 60 to 70 % bound to plasma proteins. About 5% of the total doses is doses with metabolised, mostly by the intestinal mucosa, with only 0.5 to 1.5% of the beak plasma concentrations being reached in 2-3 hours. It is Elimination half-fe of about 14 hours has been reported although this may be dose undergoing hepatic biotransformation by the cytochrome P450 system. prolonged in patients with renal impairment. Excretion is mainly in the faeces with only 10%, being present in the urine.
Composition: Fixal Fexofenadine Hydrochloride USP 30 mg.
Fixal 120 mg Tablet: Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg. tablet contains Fexofenadine
30 mg Tablet: Each film coated tablet contains
Hydrochloride USP 60 mg
Fixal 180 mg Tablet: Each film coated tablet contains Fexofenadine Hydrochloride USP 180 mg. Fixal Suspension: Each 5 ml contains Fexofenadine Hydrochloride USP 30 mg.
Indications: Seasonal Allergic Rhinitis: Fexofenadine (Fixal) tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Chronic Idiopathic Urticaria: Fexofenadine (Fixal") tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Fexofenadine Hydrochloride (Fixal) significantly reduces pruritus and the
number of wheals. Dosage & administration: Seasonal Allergic Rhinitis Adults (12 years): 120 mg once daily or 60 mg twice daily.
Children 2 to 11 Years: 30 mg or tsf twice daily.
Children 6 months to <2 years: 15 mg or 1/2 tsf twice daily.
Chronic Idiopathic Urticaria Adults (12 years): 180 mg once daily.
Children 2 to 11 Years: 30 mg or 1 tsf twice daily. Children 6 months to <2 years: 15 mg or 1/2 tsf twice daily.
Contraindications known hypersensitivity to any of its ingredients Side effects: The incidence of adverse events, including drowsiness, is not Fexofenadine HCI is contraindicated in patients with dose related is similar across subgroups defined by age, gender, and race. The other side effects are Viral infection (cold, flu), nausea, dysmenorrhea, fatigue, headache and 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 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 is administered to a nursing woman.
Precautions: The carcinogenic potential of fexofenadine was assessed using
terfenadine studies with adequate fexofenadine exposure (based on plasma area-under-the-concentration vs. time (AUC) values). No evidence of 24-month study in rats at oral doses up to 150 mg/kg of terfenadine (which carcinogenicity was observed in an 18-month study in mice and in a led to fexofenadine exposures that were approximately 3 and 5 times the exposure at the maximum recommended daily oral dose of fexofenadine hydrochloride in adults (180 mg) and children (60 mg] respectively).
Drug Interactions: Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or Ketoconazole. Antacid containing Aluminium and Magnesium Hydroxide have reduced the absorption of Fexofenadine. Fruit juices including grapefruit may reduce the bioavailability of Fexofenadine and use together should be avoided.
Over dosage: Dizziness, drowsiness, and dry mouth have been reported with fexofenadine hydrochloride overdose. Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy subjects at this dose level), and doses 2 to 690 mg twice daily for 1 month (3 healthy subjects at this dose level) or 240 mg once daily for 1 year (234 healthy subjects at this dose level) were administered without the development of clinically significant adverse events as compared to placebo.
Storage: Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
Packaging: Fixal 30 mg Tablet: Each carton contains 10X5 tablets in Fixal 60 mg Tablet: Each carton contains 10X3 tablets in Alu-PVC blister.
Alu-PVC blister.
Fixal® 120 mg Tablet: Each carton contains 10X5 tablets in Alu-PVC blister. Fixal 180 mg Tablet: Each carton contains 10X3 tablets in Alu-PVC blister. Fixal Suspension: Each bottle contains 50 ml suspension.
Opsonin Pharma
Manufactured by
Opsonin Pharma Limited
Rupatali, Barishal, Bangladesh..
Registered Trade Mark