Cetirizine + pseudoephedrine

Full Generic Medicine Info
Dosage/Direction for Use

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.
Extended-release: May be taken with or without food. Swallow whole, do not chew/crush.
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. Patient Counselling This drug may cause CNS depression (e.g. somnolence), if affected, do not drive or operate machinery.
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.
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.
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.
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.
Oral: Store between 20-25°C.
CIMS Class
Antihistamines & Antiallergics
ATC Classification
S01GX12 - cetirizine ; Belongs to the class of other ophthalmologic antiallergics.
R01BA02 - pseudoephedrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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