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Carbocisteine + Promethazine


Generic Medicine Info
Indications and Dosage
Oral
Cough
Adult: Carbocisteine 100 mg and promethazine 2.5 mg per 5 mL syrup
For relief of nonproductive and irritative cough, particularly occurring at night: 15 mL 3-4 times daily. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Child: Carbocisteine 100 mg and promethazine 2.5 mg per 5 mL syrup
For relief of nonproductive and irritative cough, particularly occurring at night: 2-<6 years 2.5-5 mL 4 times daily; 6-<12 years 7.5-12.5 mL tid; 12-15 years 12.5-15 mL tid. Use the lowest effective dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Carbocisteine + Promethazine in Singapore?
  • Rhinathiol Promethazine
Contraindications
Active peptic ulcer or gastroduodenal ulcer, active or history of agranulocytosis, comatose states or CNS depression of any cause. Children <2 years.
Special Precautions
Patient with bone marrow suppression, CV disease, risk factors for seizure (e.g. history of seizures, head trauma, alcoholism, brain damage, concomitant use of agents which may lower seizure threshold); history of peptic ulcer; decreased gastrointestinal motility, complete or partial gastrointestinal obstructions, xerostomia, visual problems, angle-closure glaucoma; complete or partial urinary obstruction, benign prostatic hyperplasia; susceptibility to orthostatic hypotension or condition that would not tolerate transient hypotensive episodes; myasthenia gravis, Parkinson's disease. Patient subjected to strenuous exercise, heat, dehydration and taking concomitant agents with anticholinergic effects. Avoid use in patients with severe respiratory disease (e.g. asthma, sleep apnoea, COPD); in children who may have Reye's syndrome or hepatic disease. Renal and hepatic impairment. Children (≥2 years) and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Orthostatic hypotension, anticholinergic effects (e.g. blurred vision, constipation, urinary retention, xerostomia), extrapyramidal symptoms (including acute dystonic reactions, akathisia, tardive dyskinesia and pseudoparkinsonism), CNS depression, photosensitivity, leucopenia, agranulocytosis, impaired core body temperature regulation, cholestatic jaundice, altered cardiac conduction.
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Gastric pain, diarrhoea, vomiting, nausea, gastric discomfort, gastrointestinal bleeding.
Nervous system disorders: Drowsiness, dizziness, headache.
Psychiatric disorders: Confusion, hallucinations.
Skin and subcutaneous tissue disorders: Allergic skin reactions and severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Potentially Fatal: Neuroleptic malignant syndrome; respiratory depression (in children <2 years).
Patient Counseling Information
This drug may cause drowsiness and dizziness, if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight.
Monitoring Parameters
Observe for mental status changes, muscle stiffness, fever, and/or autonomic instability.
Overdosage
Symptoms: Carbocisteine: Gastrointestinal disturbance. Promethazine: Mild depression of CNS and CV system to profound hypotension, respiratory depression, seizures, deep sleep, unconsciousness; drowsiness, hypothermia, tachycardia, nausea, fever, urinary retention, hyperreflexia, hypertonia, ataxia, athetosis and extensor-plantar reflexes. Paradoxical reaction characterised by hyperexcitability, abnormal movements, respiratory depression and nightmares may occur in children. Management: Symptomatic and supportive treatment. Institute general physiologic measures (e.g. maintenance of adequate ventilation) if necessary. Anticholinergic antiparkinsonian agents may be used to control extrapyramidal reactions. May perform gastric lavage or administer activated charcoal. Initiate CV monitoring immediately and include continuous ECG monitoring to identify possible arrhythmias. Administer diazepam to control convulsions. Correct acidosis and electrolyte loss. If hypotension occurs, initiate appropriate treatment including IV fluids and vasopressors (e.g. norepinephrine, phenylephrine); avoid the use of epinephrine, bretylium tosilate or dopamine.
Drug Interactions
Promethazine: Increased risk of ventricular rhythm disorder (particularly torsades de pointes) with sultopride; avoid concomitant use. May enhance the sedative and respiratory depressant actions of opiates or other CNS depressants (e.g. barbiturates, tranquillisers, antihistamines). Additive adverse effects (e.g. urinary retention, constipation, dry mouth) with atropine. May reverse the vasopressor effect of epinephrine. Increased risk of extrapyramidal effects when used concomitantly with MAOIs.
Food Interaction
Promethazine: May enhance sedative effect with alcohol.
Lab Interference
Promethazine: May lead to false-negative or false-positive pregnancy test (hCG-based) results. May alter the flare response in intradermal allergen tests. May lead to false-positive results in urine detection of amphetamine or methamphetamine. May increase serum glucose levels in glucose tolerance tests.
Action
Description:
Mechanism of Action: Carbocisteine is a mucolytic agent. Its mechanism of action is not fully understood; however, it has been shown to reduce goblet cell hyperplasia in the management of respiratory disorders associated with abnormally excessive or viscous mucus secretion.
Promethazine, a phenothiazine derivative, is a sedating antihistamine with antimuscarinic and some serotonin-antagonist properties. It competes with histamine for the binding to the H1 receptor, blocks the postsynaptic mesolimbic dopaminergic receptors in the brain, and exhibits a potent α-adrenergic blocking effect. Additionally, it suppresses the secretion of hypothalamic and hypophyseal hormones and decreases stimuli to the brainstem reticular system.
Onset: Promethazine: Approx 20 minutes.
Duration: Promethazine: Approx 4-6 hours (up to 12 hours).
Pharmacokinetics:
Absorption: Carbocisteine: Rapidly and well absorbed from the gastrointestinal tract. Bioavailability: <10%. Time to peak plasma concentration: 1-3 hours.
Promethazine: Well absorbed from the gastrointestinal tract. Bioavailability: 13-40%. Time to peak plasma concentration: 1.5-3 hours.
Distribution: Carbocisteine: Distributed into lung tissue and respiratory mucus. Volume of distribution: Approx 60-105 L.
Promethazine: Crosses the placenta and blood-brain barrier. Volume of distribution: 13.4 ± 3.6 L/kg. Plasma protein binding: 76-93%.
Metabolism: Undergoes first-pass metabolism.
Carbocisteine: Metabolised via multiple pathways including decarboxylation, acetylation and sulfoxidation; genetic polymorphism may influence the process of sulfoxidation.
Promethazine: Metabolised in the liver via hydroxylation by CYP2D6 and via N-demethylation by CYP2B6.
Excretion: Carbocisteine: Mainly via urine (as metabolites; 15.6-37.9% as unchanged drug). Elimination half-life: Approx 2 hours.
Promethazine: Via urine and faeces (mainly as inactive metabolites). Elimination half-life: 5-14 hours.
Chemical Structure

Chemical Structure Image
Carbocisteine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 193653, Carbocysteine. https://pubchem.ncbi.nlm.nih.gov/compound/Carbocysteine. Accessed June 25, 2024.


Chemical Structure Image
Promethazine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4927, Promethazine. https://pubchem.ncbi.nlm.nih.gov/compound/Promethazine. Accessed Sept. 23, 2024.

Storage
Store below 30°C. Protect from light.
MIMS Class
Cough & Cold Preparations
References
Anon. Carbocisteine [Carbocysteine] and Promethazine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2024.

Anon. Carbocisteine [Carbocysteine]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2024.

Anon. Promethazine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/03/2024.

Anon. Promethazine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2024.

Buckingham R (ed). Carbocisteine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2024.

Buckingham R (ed). Promethazine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2024.

CP Cough Syrup (Hovid Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/03/2024.

Mucoease Plus Syrup (Pharmaniaga Manufacturing Berhad). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/03/2024.

Promethiol Syrup (Y.S.P. Industries [M] Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 07/03/2024.

Disclaimer: This information is independently developed by MIMS based on Carbocisteine + Promethazine 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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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