Triprolidine + Pseudoephedrine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Allergic rhinitis; Nasal congestion As triprolidine 0.938 mg and pseudoephedrine 10 mg/mL: 2.67 mL 6 hourly. As triprolidine 1.25 mg and pseudoephedrine 30 mg/5 mL: 10 mL 4-6 hrly. As triprolidine 2.5 mg and pseudoephedrine 60 mg: 1 tab 4-6 hourly. Max (all preparations): 4 doses in 24 hours.
Dosage Details
Oral
Allergic rhinitis, Nasal congestion
Adult: Available preparations:
Triprolidine 0.938 mg and pseudoephedrine 10 mg per mL
2.67 mL 6 hourly. Max: 4 doses in 24 hours.

Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 ml
10 mL 4-6 hrly. Max: 4 doses in 24 hours.

Triprolidine 2.5 mg and pseudoephedrine 60 mg
1 tab 4-6 hourly. Max: 4 doses in 24 hours.
Child: Available preparations:
Triprolidine 0.938 mg and pseudoephedrine 10 mg per mL
6-<12 years 1.33 mL 6 hourly. Max: 4 doses in 24 hours; ≥12 years Same as adult dose.

Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 ml
6-<12 years 5 mL 4-6 hourly. Max: 4 doses in 24 hours; ≥12 years Same as adult dose.

Triprolidine 2.5 mg and pseudoephedrine 60 mg
6-<12 years 1/2 tab 4-6 hourly. Max: 4 does in 24 hours; ≥12 years Same as adult dose.
Contraindications
Severe hypertension, severe coronary artery disease. Concurrent or within 14 days of MAOI use.
Special Precautions
Patient with CV disease, diabetes mellitus, increased intraocular pressure or glaucoma, prostatic hyperplasia, urinary obstruction, respiratory disease, thyroid dysfunction. Moderate to severe renal and severe hepatic impairment. Treatment with cold medicines in children should be considered carefully due to potential risks and limited evidence of efficacy. Pregnancy and lactation.
Adverse Reactions
Significant: CNS depression, urinary retention.
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Dry mouth, abdominal pain, diarrhoea, nausea.
General disorders and admin site conditions: Fatigue.
Musculoskeletal and connective tissue disorders: Arthralgia, weakness.
Nervous system disorders: Dizziness, drowsiness, excitement.
Psychiatric disorders: Sleep disturbance, depression, hallucinations, nervousness.
Respiratory, thoracic and mediastinal disorders: Pharyngitis, thickening of bronchial secretion.
Skin and subcutaneous tissue disorders: Rash.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Drowsiness, lethargy, dizziness, ataxia, weakness, difficulty with micturition, dry skin, tachycardia, hypertension, high fever, hyperactivity, irritability, seizures and respiratory depression. Management: Supportive treatment. May perform gastric lavage up to 3 hours after ingestion. Acid diuresis or dialysis may be helpful in pseudoephedrine elimination.
Drug Interactions
Increased pharmacological effect with CNS depressants.
Pseudoephedrine: May decrease pharmacological effect of antihypertensive agents that interfere with sympathetic activity (e.g. methyldopa, guanethidine).
Potentially Fatal: Hypertensive crisis may result when pseudoephedrine is given with MAOIs.
Lab Interference
Triprolidine: May react to skin test antigen, suppressing the wheal and flare reactions.
Pseudoephedrine: May cause false-positive result with urine detection of amphetamine.
Action
Description: Triprolidine, an alkylamine derivative, is a potent competitive histamine H1-receptor antagonist hence, inhibiting the ability of histamine to combine with its receptor sites and exert its usual effects on target cells.
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.
Onset: Within 1-2 hours (antihistaminic effects); within 30 minutes (decongestant effects).
Duration: ≥8 hours (antihistaminic effects); ≥4 hours (decongestant effects).
Pharmacokinetics:
Absorption: Triprolidine: Time to peak serum concentration: Approx 2 hours.
Pseudoephedrine: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 2 hours.
Distribution: Enters breast milk (in small amounts).
Metabolism: Triprolidine: Metabolised extensively in the liver.
Excretion: Triprolidine: Mainly via urine (approx 1% as unchanged drug). Elimination half-life: Approx 3.2 hours.
Pseudoephedrine: Mainly via urine (mainly as unchanged drug and some as active metabolite). Elimination half-life: Approx 5-8 hours.
Chemical Structure

Chemical Structure Image
Triprolidine

Source: National Center for Biotechnology Information. PubChem Database. Triprolidine, CID=5282443, https://pubchem.ncbi.nlm.nih.gov/compound/Triprolidine (accessed on Jan. 23, 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. Protect from light.
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
References
Anon. Triprolidine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/08/2018.

Anon. Triprolidine Hydrochloride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/08/2018.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/08/2018.

Buckingham R (ed). Triprolidine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/08/2018.

Ed-A-Hist Pse Tablet, Coated (Edwards Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/08/2018.

Silafed Syrup (Lannett Company, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/08/2018.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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