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Faxoday 120/180

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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.

Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound indentified in urine and faeces of animals and men. 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 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.

The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120mg/180mg one daily taken before a meal.

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.

The administration of 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.

 

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.

 

 

 

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