Triprolidine + Pseudoephedrine + Dextromethorphan


Concise Prescribing Info
Indications/Uses
Upper respiratory tract symptoms associated with allergy.
Dosage/Direction for Use
Adult : PO Each bottle contains triprolidine 1.25 mg, pseudoephedrine 30 mg and dextromethorphan 10 mg per 5 mL: 10 mL 4-6 hourly up to 4 times daily.
Dosage Details
Oral
Upper respiratory tract symptoms associated with allergy
Adult: Available preparation:
Each bottle contains triprolidine 1.25 mg, pseudoephedrine 30 mg and dextromethorphan 10 mg per 5 mL

10 mL 4-6 hourly up to 4 times daily.
Child: ≥12 years Same as adult dose.
Contraindications
Severe hypertension, severe coronary artery disease, asthma, cough accompanied by excessive secretion, risk of developing respiratory failure. Concurrent or within 14 days of MAOI use. Children <12 years.
Special Precautions
Patient with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure, prostate enlargement, history of drug abuse. Moderate to severe renal or severe hepatic impairment. Treatment with a cough medicine in children (especially under 12 years old) should be considered carefully due to potential risks and limited evidence on efficacy. Pregnancy and lactation.
Adverse Reactions
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Dry mouth, nausea, vomiting, gastrointestinal disorder.
Psychiatric disorders: Sleep disturbance, drowsiness.
Renal and urinary disorders: Urinary retention.
Skin and subcutaneous tissue disorders: Skin rashes.
Patient Counseling Information
This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, tachycardia, hypertension, hyperpyrexia, hyperactivity, irritability, convulsions, difficulty with micturition, nausea, and vomiting. Management: Maintain and support respiration and control convulsions. May perform gastric lavage or catheterisation of the bladder if necessary. Elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis. For dextromethorphan toxicity in children, may use naloxone as a specific antagonist.
Drug Interactions
Increased pharmacological effect with CNS depressants (e.g. sedatives, tranquilizers, TCA, opioid analgesics).
Pseudoephedrine: May decrease pharmacological effect of antihypertensive agents that interfere with sympathetic activity (e.g. reserpine, methyldopa).
Dextromethorphan: Increased toxic effect when used with potent CYP2D6 enzyme inhibitors (e.g. fluoxetine, paroxetine, quinidine, terbinafine).
Potentially Fatal: Hypertensive crisis may result when pseudoephedrine is given with MAOIs.
Food Interaction
Increased sedation with alcohol.
Lab Interference
Triprolidine: May suppress the wheel and flare reactions to skin test antigens.
Pseudoephedrine: May cause false-positive result with urine detection of amphetamine.
Dextrometorphan: False-positive phencyclidine, opioids and heroin urine drug screen.
Action
Description: Triprolidine, an alkylamine derivative, is a potent competitive histamine H1 receptor antagonist blocking the action of histamine to combine with its receptor sites and exert its usual effects in 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 muscosa, relaxation of bronchial muscles and, increased heart rate and contractility.
Dextromethorphan, a centrally-acting antitussive agent, depresses the medullary cough centre through sigma receptor stimulation, resulting to decreased sensitivity of cough receptors and interruption of cough impulse transmission.
Pharmacokinetics:
Absorption: Triprolidine: Time to peak plasma concentration: Approx 2 hours.
Pseudoephedrine: Readily absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1-3 hours.
Dextromethorphan: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 2-3 hours.
Distribution: Triprolidine: Enters breast milk (in small amounts).
Pseudoephedrine: Enters breast milk (in small amounts). Volume of distribution: 2.64-3.51 L/kg.
Metabolism: Triprolidine: Metabolised extensively in the liver.
Pseudoephedrine: Undergoes n-demethylation to active metabolite, norpseudoephedrine.
Dextromethorphan: Metabolised in the liver via demethylation by CYP2D6 to active metabolite, dextrorphan; CYP3A4 and CYP3A5 from smaller amounts of 3-hydroxy and 3-methoxy derivatives.
Excretion: Triprolidine: Mainly via urine. Elimination half-life: 3-5 hours.
Pseudoephedrine: Via urine, as unchanged drug. Elimination half-life: Approx 5-8 hours.
Dextromethorphan: Via urine (as unchanged drug and demethylated metabolites). Elimination half-life: 2-4 hours (extensive metabolisers); 24 hours (poor metabolisers).
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)


Chemical Structure Image
Dextromethorphan

Source: National Center for Biotechnology Information. PubChem Database. Dextromethorphan, CID=5360696, https://pubchem.ncbi.nlm.nih.gov/compound/Dextromethorphan (accessed on Jan. 20, 2020)

Storage
Store below 25°C. Protect from light.
ATC Classification
R01BA02 - pseudoephedrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
R06AX07 - triprolidine ; Belongs to the class of other antihistamines for systemic use.
R05DA09 - dextromethorphan ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
References
Anon. Dextromethorphan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2018.

Anon. Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2018.

Anon. Triprolidine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2018.

Anon. Triprolidine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2018.

Buckingham R (ed). Dextromethorphan. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/08/2018.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/08/2018.

Buckingham R (ed). Triprolidine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/08/2018.

Triponel (Llorens Pharmaceutical Internation Division Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/08/2018.

Disclaimer: This information is independently developed by MIMS based on Triprolidine + Pseudoephedrine + Dextromethorphan 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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