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Indications/Uses
Respiratory tract infections associated with excessive and/or viscous mucus.
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Dosage/Direction for Use
Adult : PO Each bottle contains carbocisteine (mg)/promethazine hydrochloride (mg): 100/2.5: 15 mL tid.
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Dosage Details
Oral
Respiratory tract infections associated with excessive and/or viscous mucus Adult: Available preparation:
Each bottle contains carbocisteine 100 mg and promethazine hydrochloride 2.5 mg 15 mL tid. Child: Each bottle contains carbocisteine 100 mg and promethazine hydrochloride 2.5 mg <2 years Not recommended. 2-5 years 2.5-5 mL four times a day. 6-12 years 7.5-12.5 mL tid. 12-15 years 12.5-15 mL tid. |
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Contraindications
Active peptic ulcer. Children <2 years.
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Special Precautions
Patient with epilepsy, signs and symptoms suggestive of Reye’s syndrome. Children >2 years. Pregnancy and lactation.
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Adverse Reactions
Significant: Anticholinergic effects (e.g. blurred vision, dry mouth, urinary retention). Drowsiness, dizziness, restlessness, headache, nightmare, tiredness, disorientation, photosensitivity.
Gastrointestinal disorders: Nausea, gastric discomfort, GI bleeding, diarrhoea. Skin and subcutaneous tissue disorders: Rarely, rash, urticaria, pruritus. Potentially Fatal: Respiratory depression and apnoea especially in children. |
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Patient Counseling Information
Avoid prolonged exposure to sunlight.
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MonitoringParameters
Monitor mental status, and CNS effects (e.g. sedation).
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Drug Interactions
May potentiate the effects of antihypertensive agents, other CNS depressants, MAOI(s) and analgesics.
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Food Interaction
May enhance the CNS depressant effect of alcohol.
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Lab Interference
Promethazine: May interfere with immunological urine pregnancy test to produce false-positive or false-negative results. Increased serum glucose may be seen with glucose tolerance tests. May lead to a false-positive result with urine detection of amphetamine/methamphetamine. May alter the flare response in intradermal allergen tests.
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Action
Description: Carbocisteine is a mucolytic agent that reduces goblet cell hyperplasia in the management of respiratory disorders associated with abnormally excessive or viscous mucus secretion.
Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits a strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system. Onset: Promethazine: Approx 20 minutes. Pharmacokinetics: Absorption: Carbocisteine: Rapidly and well absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 2 hours. Promethazine: Rapidly and well absorbed. Bioavailabilty: Approx 25%. Time to peak plasma concentration: 2-3 hours. Distribution: Carbocisteine: Penetrates into lung tissue and respiratory mucus. Promethazine: Crosses the blood-brain barrier and placenta; enters breast (small amounts). Volume of distribution: 13.3 ± 3.6 L/kg. Plasma protein binding: 76-93%. Metabolism: Carbocisteine: Metabolised via acetylation, decarboxylation, and sulfoxidation by genetic polymorphism. Undergoes extensive hepatic-first pass metabolism via hydroxylation by CYP2D6 and N-demethylation by CYB2B6. Excretion: Carbocisteine: Via urine, as unchanged drug and metabolites. Promethazine: Via urine; faeces, as metabolites. Elimination half-life: Approx 5-14 hours. |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. Carbocysteine, CID=193653, https://pubchem.ncbi.nlm.nih.gov/compound/Carbocysteine (accessed on Jan. 21, 2020)  Source: National Center for Biotechnology Information. PubChem Database. Promethazine, CID=4927, https://pubchem.ncbi.nlm.nih.gov/compound/Promethazine (accessed on Jan. 21, 2020) |
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Storage
Store between 20-25°C. Protect from light.
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MIMS Class
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References
Anon. Carbocisteine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2018. Anon. Promethazine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2018. Buckingham R (ed). Carbocisteine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2018. Buckingham R (ed). Promethazine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2018.
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