Faxoday 120/180
- ENG
- မြန်မာ
Fexofenadine Hydrochloride Tablets USP 120mg/180mg
Composition:
Each Film-Coated Tablet Contains:
Fexofenadine Hydrochloride USP 120mg
Composition:
Each Film-Coated Tablet Contains:
Fexofenadine Hydrochloride USP 180mg
DESCRIPTION
Faxoday 120: Blue colored, film coated caplets plain on both sides.
Faxoday 180: Orange colored, film coated caplets plain on both sides.
ACTION AND PHARMACOLOGY
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective H1-receptor antagonist activity.
Pharmacology: Fexofenadine hydrochloride blocks action of histamine and displaces histamine from the H1 receptor. Antihistamines bind to H1 receptors and prevents histamine from eliciting allergic reactions.
PHARMACOKINETICS
Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. Fexofenadine is 60-70% plasma protein bound.
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.
INDICATIONS
Relief of symptoms associated with chronic idiopathic urticaria.
DOSAGE
Adults
The recommended dose of fexofenadine hydrochloride for adults is 120 mg/180mg once daily taken before a meal.
- Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120mg/180mg one daily taken before a meal.
- Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.
CONTRAINDICATIONS:
Hypersensitivity to the active substance or excipients present in this formulation.
PRECAUTIONS
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.
INTERACTIONS
Coad ministration 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.
TERATOGENICITY/ EFFECTS IN PREGNANCY
Fexofenadine hydrochloride was found to be non- teratogenic in various in vitro and in vivo tests.
Pregnancy
Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Breastfeeding
Fexofenadine hydrochloride is not recommended during Breast feeding
ADVERSE REACTIONS
Adverse reactions may include vomiting, headache, cough, diarrhea, dizziness, stomach discomfort, Dysmenorrhea
OVERDOSAGE
Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride.
PRESENTATION
Faxoday 120/180: Alu- Alu Blister of 1×10 Tablets/3×10 Tablets
STORAGE
Store below 30° C. Protect from light and moisture.