Triprolidine + Pseudoephedrine


Generic Medicine Info
Indications and Dosage
Oral
Allergic rhinitis, Common cold
Adult: Available preparations:
Triprolidine 2.5 mg and pseudoephedrine 60 mg tab
Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL liquid/syrup

For the temporary relief of symptoms such as runny nose, nasal congestion, sneezing, itchy nose or throat, itchy or watery eyes, and nasal passages swelling: As tab: 1 tab 4-6 hourly. Max: 4 doses (4 tabs) in 24 hours. As liquid/syrup: 10 mL 4-6 hourly. Max: 4 doses (40 mL) in 24 hours.
Child: Available preparations:
Triprolidine 2.5 mg and pseudoephedrine 60 mg tab
Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL liquid/syrup

For the temporary relief of symptoms such as runny nose, nasal congestion, sneezing, itchy nose or throat, itchy or watery eyes, and nasal passages swelling: As tab: 6-<12 years 1/2 tab 4-6 hourly. Max: 4 doses (2 tabs) in 24 hours; ≥12 years Same as adult dose. As liquid/syrup: 6-<12 years 5 mL 4-6 hourly. Max: 4 doses (20 mL) in 24 hours; ≥12 years Same as adult dose.
Contraindications
Severe hypertension, severe coronary artery disease, hyperthyroidism. Concurrent use with or within 14 days of stopping MAOIs.
Special Precautions
Patient with CV disease, diabetes mellitus, increased intraocular pressure or glaucoma, prostatic hyperplasia and/or genitourinary obstruction, acute or chronic asthma, emphysema, chronic bronchitis, thyroid dysfunction, occlusive vascular disease, peptic ulcer disease (including stenosing peptic ulcer), pyloroduodenal obstruction. Hepatic and moderate to severe renal impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Severe skin reactions (e.g. acute generalised exanthematous pustulosis); restlessness, hallucinations, sleep disturbances; excitation (particularly in children); ischaemic colitis, ischaemic optic neuropathy. Rarely, posterior reversible encephalopathy syndrome/reversible cerebral vasoconstriction syndrome.
Cardiac disorders: Tachycardia.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Dry mouth, gastrointestinal disorder, nausea, vomiting, diarrhoea, constipation, abdominal pain.
Nervous system disorders: Headache, dizziness, paradoxical stimulation, psychomotor impairment, somnolence.
Renal and urinary disorders: Urinary retention (particularly in men with prostate enlargement), dysuria.
Respiratory, thoracic and mediastinal disorders: Thickening of bronchial secretions.
Skin and subcutaneous tissue disorders: Diaphoresis.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, difficulty with micturition, dry skin and mucous membranes, tachycardia, hypertension, hyperactivity, hyperpyrexia, irritability, and seizures. Management: Supportive treatment. Acid diuresis or dialysis may help increase pseudoephedrine elimination. Catheterisation of the bladder may be necessary.
Drug Interactions
Triprolidine: May enhance the sedative effect of other CNS depressants (e.g. sedatives, tranquilisers). May enhance the anticholinergic effect with other antimuscarinic drugs (e.g. atropine, certain antidepressants).
Pseudoephedrine: May partially reverse the hypotensive effect of antihypertensive agents that interfere with sympathetic activity (e.g. methyldopa, guanethidine, reserpine). May worsen or provoke ventricular arrhythmias when used with halogenated anaesthetic agents (e.g. halothane, enflurane, isoflurane).
Potentially Fatal: Pseudoephedrine: Increased risk of hypertensive crisis with MAOIs.
Food Interaction
Triprolidine: May enhance the sedative effect of alcohol.
Lab Interference
Triprolidine: May interfere with skin test antigens, suppressing the wheal and flare reactions.
Pseudoephedrine: May cause false-positive result in urine detection of amphetamine.
Action
Description: Triprolidine, an alkylamine derivative, is a competitive histamine H1-receptor antagonist with antimuscarinic and mild sedating effects. It blocks the action of histamine to combine with its receptor sites and exert its usual effects on target cells.
Pseudoephedrine is a direct- and indirect-acting sympathomimetic agent and an effective upper respiratory tract decongestant. It directly stimulates α- and β-adrenergic receptors, thereby causing vasoconstriction of the respiratory mucosa and relaxation of bronchial smooth muscle.
Onset: Triprolidine: Antihistaminic effect: Within 1-2 hours.
Pseudoephedrine: Decongestant effect: Within 30 minutes.
Duration: Triprolidine: Antihistaminic effect: 8 hours.
Pseudoephedrine: Decongestant effect: ≥4 hours.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 2 hours.
Pseudoephedrine: Readily and almost completely absorbed from the gastrointestinal tract.
Distribution: Enters breast milk (small amounts).
Metabolism: Triprolidine: Metabolised extensively in the liver.
Pseudoephedrine: Incompletely metabolised (<1%) in the liver via N-demethylation to an inactive metabolite.
Excretion: Triprolidine: Via urine (approx 1% as unchanged drug). Elimination half-life: Approx 3.2 hours.
Pseudoephedrine: Via urine (approx 43-96% as unchanged drug). Elimination half-life: Dependent on urinary pH; approx 5-8 hours (when urinary pH is 5.8).
Chemical Structure

Chemical Structure Image
Triprolidine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5282443, Triprolidine. https://pubchem.ncbi.nlm.nih.gov/compound/Triprolidine. Accessed June 28, 2022.


Chemical Structure Image
Pseudoephedrine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 7028, Pseudoephedrine. https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine. Accessed June 28, 2022.

Storage
Store between 15-30°C. Protect from light and moisture.
MIMS Class
Antihistamines & Antiallergics / Cough & Cold Preparations
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
References
Actimin Tablet (DuoPharma [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/06/2022.

Anon. Pseudoephedrine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/06/2022.

Anon. Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/06/2022.

Anon. Triprolidine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/04/2022.

Anon. Triprolidine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/06/2022.

Anon. Triprolidine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/06/2022.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/04/2022.

Buckingham R (ed). Triprolidine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/04/2022.

Decondine Syrup; Tablet (Sunward Pharmaceutical Pte. Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 24/06/2022.

Ed-A-Hist PSE Tablet, Coated 60 mg/2.5 mg (Edwards Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.

Fedac Tablets; Syrup (Teva Pharmaceutical Investments Singapore Pte. Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 24/06/2022.

Maxi-Tuss TR Liquid 30 mg/1.25 mg (MCR American Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/04/2022.

Multi-Action Actifed Tablets 2.5 mg/60 mg (McNeil Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/04/2022.

Prolidin Syrup (Dynapharm [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/06/2022.

Pseudoephedrine; Triprolidine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 24/06/2022.

Disclaimer: This information is independently developed by MIMS based on Triprolidine + 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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