Fexofenadine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Seasonal allergic rhinitis

Adult: 120 mg once daily. Alternatively, 60 mg bid or 180 mg once daily. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: 2-11 years 30 mg bid; ≥12 years Same as adult dose. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Chronic idiopathic urticaria

Adult: 180 mg once daily. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: 6 months-<2 years 15 mg bid; 2-11 years 30 mg bid; ≥12 years 60 mg bid or 180 mg once daily. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Administration

Should be taken on an empty stomach. Do not take w/ fruit juice.

Special Precautions

Patient with current or history of CV disease. Renal and hepatic impairment. Children. Pregnancy and lactation.

Adverse Reactions

Cardiac disorders: Palpitations, tachycardia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Hypersensitivity reactions (e.g. angioedema, chest tightness, flushing).
Nervous system disorders: Headache, drowsiness, dizziness.
Psychiatric disorders: Insomnia, nervousness, sleep disorders or nightmares.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.

Monitoring Parameters

Monitor relief of symptoms.

Overdosage

Symptoms: Dizziness, drowsiness, fatigue and dry mouth. Management: Symptomatic and supportive treatment.

Drug Interactions

Increased plasma concentrations with erythromycin and ketoconazole. Reduced bioavailability and absorption with antacids containing Al and Mg.

Food Interaction

Decreased bioavailability with high-fat meals, fruit juice (e.g. apple, grapefruit, orange).

Lab Interference

May suppress the wheal and flare reactions to skin test antigens.

Action

Description:
Mechanism of Action: Fexofenadine is a non-sedating antihistamine and an active metabolite of terfenadine. It competes with histamine for H₁-receptor on effector cells in the blood vessels, gastrointestinal tract and respiratory tract.
Onset: 2 hours.
Duration: 24 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 33%; decreased with high-fat meals, fruit juice. Time to peak plasma concentration: Approx 2.6 hours (conventional tab); 2 hours (orally disintegrating tab); approx 1 hour (susp).
Distribution: Plasma protein binding: 60-70%, mainly to albumin and α₁-acid glycoprotein.
Metabolism: Undergoes minimal metabolism in the liver (approx 5%) into methylester metabolite.
Excretion: Mainly via faeces (80%); urine (12%, as unchanged drug). Elimination half-life: 14.4 hours.

Chemical Structure

Storage

Store between 20-25°C.

MIMS Class

Antihistamines & Antiallergics

ATC Classification

R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.

References

Anon. Fexofenadine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/03/2022.

Buckingham R (ed). Fexofenadine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2022.

Childrens Fexofenadine Hydrochloride Allergy Suspension (Taro Pharmaceuticals U.S.A., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2022.

Fexofenadine Cipla 120 mg Film-Coated Tablets (Cipla [EU] Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2022.

Fexofenadine HCL Tablet (Akron Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2022.

Fexofenadine Hydrochloride 180 mg Film-Coated Tablets (Generics [UK] Limited t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2022.

Joint Formulary Committee. Fexofenadine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2022.

Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics. Telfast 6-11 Years 30 mg Film Coated Tablets; Telfast 60 mg Film Coated Tablets; Telfast 120 mg Film Coated Tablets; Telfast 180 mg Film Coated Tablets; Telfast Oral Liquid, 6 mg/mL Suspension data sheet 20 December 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 10/02/2022.

Telfast 180 mg Tablets (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/02/2022.

Telfast 30 mg Film-Coated Tablets (Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2022.

Telfast 30 mg/5 mL Oral Suspension (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/02/2022.

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