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 years1/2 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: Mechanism of Action: 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
Triprolidine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5282443, Triprolidine. https://pubchem.ncbi.nlm.nih.gov/compound/Triprolidine. Accessed May 31, 2023.
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.
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