Fexofenadine + Pseudoephedrine


Concise Prescribing Info
Indications/Uses
Seasonal allergic rhinitis.
Dosage/Direction for Use
Adult : PO Each tab contains fexofenadine 60 mg and pseudoephedrine 120 mg: 1 tab bid. Each tab contains fexofenadine 180 mg and pseudoephedrine 240 mg: 1 tab once daily.
Dosage Details
Oral
Seasonal allergic rhinitis
Adult: Each tab contains fexofenadine 60 mg and pseudoephedrine 120 mg: 1 tab bid. Each tab contains fexofenadine 180 mg and pseudoephedrine 240 mg: 1 tab once daily.
Child: ≥12 yr Same as adult dose.
Renal Impairment
CrCl (mL/min) Dosage
<80 Each tab contains fexofenadine 60 mg and pseudoephedrine 120 mg: Initially, 1 tab once daily.
Contraindications
Severe HTN or coronary artery disease, narrow-angle glaucoma, urinary retention. Patient receiving MAOIs or w/in 14 days of MAOI therapy withdrawal.
Special Precautions
Patient w/ CV disease (e.g. HTN, ischaemic heart disease), DM, thyroid dysfunction, increased intraocular pressure, prostatic hypertrophy or urinary obstruction, seizure disorder. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Palpitations, abdominal pain, indigestion, nausea, headache, insomnia, agitation, upper resp infection.
MonitoringParameters
Monitor CNS effects (e.g. stimulation or depression).
Drug Interactions
Increased plasma levels w/ ketoconazole or erythromycin. Increased CNS effect w/ other sympathomimetic amines. Increased ectopic pacemaker activity w/ digitalis. Decreased plasma levels w/ Al and Mg containing antacids. May reduce the effect of antihypertensive drugs which interfere w/ sympathetic activity (e.g. methyldopa, mecamylamine, reserpine).
Potentially Fatal: Enhanced hypertensive effect w/ MAOIs.
Food Interaction
Reduced bioavailability and exposure w/ grapefruit, orange and apple juice.
Action
Description: Fexofenadine is a selective peripheral H1-receptor antagonist thus, inhibits antigen-induced bronchospasm and histamine release. Pseudoephedrine exerts decongestant effect on the nasal mucosa.
Pharmacokinetics:
Absorption: Fexofenadine: Rapidly absorbed from the GI tract. Time to peak plasma concentration: 2-3 hr. Pseudoephedrine: Readily absorbed from the GI tract.
Distribution: Fexofenadine: Plasma protein binding: Approx 60-70%. Pseudoephedrine: Enters breast milk (small amounts).
Metabolism: Fexofenadine: Hepatically (approx 5% of the total dose). Pseudoephedrine: Hepatically (<1% of the total dose).
Excretion: Fexofenadine: Via faeces (80%), urine (11%). Elimination half -life: Approx 14 hr. Pseudoephedrine: Via urine (55-75%, as unchanged drug). Elimination half-life: Approx 5-8 hr.
Chemical Structure

Chemical Structure Image
Fexofenadine

Source: National Center for Biotechnology Information. PubChem Database. Fexofenadine, CID=3348, https://pubchem.ncbi.nlm.nih.gov/compound/Fexofenadine (accessed on Jan. 20, 2020)


Chemical Structure Image
Pseudoephedrine

Source: National Center for Biotechnology Information. PubChem Database. Pseudoephedrine, CID=7028, https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C.
ATC Classification
R01BA02 - pseudoephedrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.
References
Allegra-D 24 Hour Tablet, Film Coated (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 29/06/2015.

Anon. Fexofenadine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/06/2015.

Buckingham R (ed). Fexofenadine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/06/2015.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/06/2015.

Disclaimer: This information is independently developed by MIMS based on Fexofenadine + Pseudoephedrine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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