Cetirizine + Pseudoephedrine


Concise Prescribing Info
Indications/Uses
Allergic rhinitis.
Dosage/Direction for Use
Adult : PO Each extended-release tab contains cetirizine 5 mg and pseudoephedrine 120 mg: 1 tab bid.
Dosage Details
Oral
Allergic rhinitis
Adult: Available preparation:
Cetirizine 5 mg and pseudoephedrine 120 mg

As extended-release tab: 1 tab bid.
Child: ≥12 years Same as adult dose.
Elderly: Limit cetirizine dose to 5 mg once daily.
Renal Impairment
1 tab once daily.
Hepatic Impairment
1 tab once daily.
Administration
Extended-Release: May be taken with or without food. Swallow whole, do not chew/crush.
Contraindications
Narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease. Children below 12 years. Concomitant or within 14 days of MAOI use.
Special Precautions
Patient with CV disease (e.g. hypertension, ischaemic heart disease), diabetes mellitus, increased intraocular pressure, thyroid dysfunction, urinary obstruction (including prostatic hypertrophy). Renal and hepatic impairment. Elderly. Treatment with cold medicines in children should be considered carefully due to potential risks and limited evidence on efficacy. Pregnancy and lactation.
Adverse Reactions
Significant: CNS stimulation or depression, CV collapse with hypotension.
Cardiac disorders: Tachycardia, palpitation.
Gastrointestinal disorders: Dry mouth, nausea.
General disorders and administration site conditions: Asthenia, restlessness, weakness, ataxia.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Headache, dizziness, vertigo, convulsions.
Psychiatric disorders: Insomnia, anxiety, fear, nervousness, hallucinations, dysphonia.
Renal and urinary disorders: Dysuria.
Respiratory, thoracic and mediastinal disorders: Respiratory difficulty, epistaxis, pharyngitis.
Vascular disorders: Pallor.
Patient Counseling Information
This drug may cause CNS depression (e.g. somnolence), if affected, do not drive or operate machinery.
Overdosage
Symptoms: Hypertension, arrhythmia, tachycardia, CNS depression (e.g. sedation, cyanosis, apnoea, unconsciousness, CV collapse) or stimulation (hallucinations, tremor, seizures, insomnia). Management: Symptomatic and supportive treatment. Induce vomiting or employ gastric lavage. Diazepam may be given to manage seizures. Hypertension may be treated with α-blockers and tachycardia with β-blockers.
Drug Interactions
Increased pharmacological effect with CNS depressants.
Pseudoephedrine: Increased ectopic pacemaker activity may occur when given with digitalis. May decrease pharmacological effect of antihypertensive agents that interfere with sympathetic activity (e.g. reserpine, methyldopa).
Potentially Fatal: Hypertensive crisis may result when pseudoephedrine is given with MAOIs.
Food Interaction
Increased CNS depression with alcohol.
Action
Description: Cetirizine is an antihistamine which competitively and selectively inhibits H1 receptors in the gastrointestinal and respiratory tract and blood vessels.
Pseudoephedrine is a sympathomimetic agent which has a decongestant action on the nasal mucosa. It directly stimulates α- and β-adrenergic receptors thereby causing vasoconstriction of respiratory mucosa, relaxation of bronchial muscles and increased heart rate and contractility.
Pharmacokinetics:
Absorption: Cetirizine: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 2.2 hours.
Pseudoephedrine: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: 4.4 hours.
Distribution: Enters breast milk.
Cetirizine: Plasma protein binding: 93%.
Pseudoephedrine: Volume of distribution: 2.6-3.3 L/kg.
Metabolism: Cetirizine: Metabolised via oxidative O-dealkylation.
Pseudoephedrine: Minimally metabolised via N-demethylation to norpseudoephedrine.
Excretion: Cetirizine: Mainly via urine (70%, approx 50% as unchanged drug); faeces (10%). Elimination half-life: 7.9 hours.
Pseudoephedrine: Mainly via urine as unchanged drug and as metabolites. Elimination half-life: 6 hours.
Chemical Structure

Chemical Structure Image
Cetirizine

Source: National Center for Biotechnology Information. PubChem Database. Cetirizine, CID=2678, https://pubchem.ncbi.nlm.nih.gov/compound/Cetirizine (accessed on Jan. 21, 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
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
References
Anon. Cetirizine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/08/2018.

Buckingham R (ed). Cetirizine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2018.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2018.

Cetirizine HCl and Pseudoephedrine HCl ER (Bryant Ranch Prepack). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/08/2018.

Preston CL (ed). Pseudoephedrine Interactions. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2018.

Zyrtec-D 12 Hour (Pfizer Inc, NY). U.S. FDA. https://www.fda.gov/. Accessed 02/08/2018.

Zyrtec-D Allergy Plus Congestion (Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/08/2018.

Disclaimer: This information is independently developed by MIMS based on Cetirizine + 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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