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Fexofenadine information from DrugsUpdate  

See Available Brands of Fexofenadine in India

P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *

Fexofenadine (Allegra, Telfast, Fastofen, Tilfur) is an antihistamine drug used in the treatment of hayfever and similar allergy symptoms. It was developed as a successor of and alternative to terfenadine (brand names include Triludan and Seldane), an antihistamine with potentially serious contraindications. Fexofenadine, like other second and third-generation antihistamines, does not readily cross the blood-brain barrier, and so causes less drowsiness than first-generation histamine-receptor antagonists. It works by being an antagonist to the H1 receptor.

It has been described as both second-generation and third-generation.

Pharmacodynamics

Pharmacokinetics

Fexofenadine, an active metabolite of terfenadine, is a competitive peripheral histamine H1-receptor antagonist on effector cells in the GI tract, blood vessels and respiratory tract.

Absorption
Absorbed rapidly from the GI tract (oral); peak plasma concentrations after 2-3 hours.

Distribution
Enters breast milk. 60-70% bound to plasma proteins.

Metabolism
Intestinal mucosa (5% of total dose); hepatic (0.5-1.5% of dose).

Excretion
Mainly via faeces, via urine (10% of dose); 14 hours (elimination half-life; may be prolonged in renal impairment).

Fexofenadine Indications / Fexofenadine Uses

Information Not Available

Fexofenadine Adverse Reactions / Fexofenadine Side Effects

Viral infection (cold/flu); headache, dizziness, drowsiness, fatigue; nausea, dyspepsia, dysmenorrhoea.

Precautions

Phenylketonurics
Fexofenadine hydrochloride tablets do not contain phenylalanine

Special Precautions

Renal impairment. Pregnancy, lactation; children <6 years.

Other Drug Interactions

Co-admin with ketoconazole or erythromycin may increase plasma levels of fexofenadine. May increase adverse effects of other anticholinergics and CNS depressants. May increase arrhythmogenic effect of antipsychotic agents (phenothiazines); avoid concurrent usage. May reduce the efficacy of betahistine. Pramlintide may increase the anticholinergic effect of fexofenadine. Bioavailability may be increased by verapamil. Efficacy may be reduced by rifampin.

Other Interactions

Food Interaction
Decreased levels with St John's wort. Fruit juice (apple, grapefruit, orange) may reduce bioavailability of fexofenadine by about 36%. Possible increased risk of sedation with ethanol.

Dosage

Oral
Seasonal allergic rhinitis
Adult: 120 mg once daily.
Child: 6-11 yr: 30 mg bid.
Renal impairment: Adult: Initially, 60 mg once daily. Child: 6 mth-<2 year: 15 mg once daily and 2-11 yr: 30 mg once daily.

Oral
Chronic idiopathic urticaria
Adult: 180 mg once daily.
Child: 6 mth-<2 yr: 15 mg bid; ≥2 yr: 30 mg bid.
Renal impairment: Adult: Initially, 60 mg once daily. Child: 6 mth-<2 year: 15 mg once daily and 2-11 yr: 30 mg once daily.

Food(before/after)

May be taken with or without food.

List of Contraindications

Fexofenadine and Pregnancy

Caution when used during pregnancy.

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Fexofenadine and Lactation

Caution when used during lactation

Fexofenadine and Children

The recommended doses of Fexofenadine hydrochloride in pediatric patients 6 months to 11 years of age are based on cross-study comparison of the pharmacokinetics of Fexofenadine in adults and pediatric subjects and on the safety profile of Fexofenadine hydrochloride in both adult and pediatric subjects at doses equal to or higher than the recommended doses. The safety and effectiveness of Fexofenadine hydrochloride in pediatric patients under 6 months of age have not been established.

Fexofenadine and Geriatic

Clinical studies of Fexofenadine hydrochloride tablets and capsules did not include sufficient numbers of subjects aged 65 years and over to determine whether this population responds differently from younger subjects. Other reported clinical experience has not identified differences in responses between the geriatric and younger subjects. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Fexofenadine and Other Contraindications

Hypersensitivity.

Storage

Oral
Store at 20-25°C.

Lab interference

Oral
Store at 20-25°C.

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