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Promethazine


Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Allergic conditions
Adult: As promethazine hydrochloride: 25-50 mg via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. If continued treatment is necessary, switch to oral route as soon as possible. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Intramuscular, Intravenous
Adjunct to pre- or post-operative sedation
Adult: As an adjunct to analgesics (at a reduced dose): As promethazine hydrochloride: 25-50 mg via deep IM inj (preferred), via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As an adjunct to analgesics or barbiturates (at a reduced dose): As promethazine hydrochloride: ≥2 years 0.5-1.1 mg/kg. Max dose: 12.5-25 mg. Dose may be given via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Use the lowest effective dose. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Intramuscular, Intravenous
Obstetric sedation
Adult: As promethazine hydrochloride: Early stages of labour: 50 mg. Established labour: In combination with an opioid analgesic (at a reduced dose): 25-75 mg, may be repeated once or twice at 4-hour intervals during labour. Max total dose: 100 mg during a 24-hour period of labour. Doses are given via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Intramuscular, Intravenous
Sedation
Adult: As promethazine hydrochloride: 25-50 mg via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As promethazine hydrochloride: 5-10 years 6.25-12.5 mg via deep IM inj. Use the lowest effective dose.

Intramuscular, Intravenous
Nausea and vomiting
Adult: As promethazine hydrochloride: 12.5-25 mg, repeated at intervals of not less than 4 hours if needed, given via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As promethazine hydrochloride: ≥2 years 0.25-0.5 mg/kg 4-6 hourly as needed. Dose may be given via deep IM inj (preferred), or via slow IV inj or injected into the tubing of freely running infusion in a concentration of not more than 25 mg/mL (usually diluted to 2.5 mg/mL). Max rate of infusion: 25 mg/min. Use the lowest effective dose. Dosage, IV dilution, and IV infusion rate recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Motion sickness
Adult: As promethazine hydrochloride: 25 mg given the night before travelling, may be repeated after 6-8 hours if necessary. Alternatively, 25 mg given 30-60 minutes before travelling, may be repeated 8-12 hours later if needed; may administer 25 mg bid on subsequent travel days if necessary. As promethazine teoclate: Prophylaxis: 25 mg given the night before travelling (for long journeys) or 1-2 hours before travelling (for short journeys). Treatment: 25 mg as soon as possible and repeated in the same evening, followed by a 3rd dose the next evening. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As promethazine hydrochloride: 2-5 years 5 mg given the night before the journey and repeated after 6-8 hours if necessary; 6-12 years 10 mg given the night before the journey and repeated after 6-8 hours if necessary. As promethazine teoclate: 5-10 years Prophylaxis: 12.5 mg given the night before travelling (for long journeys) or 1-2 hours before travelling (for short journeys). Treatment: 12.5 mg as soon as possible and repeated in the evening, followed by a 3rd dose the next evening; >10 years Same as adult dose. Use the lowest effective dose. Dosage recommendations and approved age groups may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Allergic conditions
Adult: As promethazine hydrochloride: 25 mg at night, may be increased to 25 mg bid if necessary. Alternatively, 10-20 mg 2-3 times daily. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As promethazine hydrochloride: 2-5 years 5-15 mg as a single dose at night or 5 mg bid; 6-12 years 10-25 mg as a single dose at night or 5-10 mg bid. Use the lowest effective dose. Dosage recommendations and approved age groups may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Nausea and vomiting
Adult: Due to labyrinthitis or other causes: As promethazine teoclate: 25 mg at night, may be increased to 50 mg or 75 mg at night or to 25 mg 2 or 3 times daily if necessary. Max: 100 mg daily. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: Due to labyrinthitis or other causes: As promethazine teoclate: 5-10 years 12.5-37.5 mg daily; >10 years Same as adult dose. Use the lowest effective dose. Dosage recommendations and approved age groups may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Insomnia
Adult: For short-term management: As promethazine hydrochloride: 20-50 mg at night.

Oral
Nausea and vomiting
Adult: As promethazine hydrochloride: 12.5-25 mg 4-6 hourly as needed. Max: 100 mg daily. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As promethazine hydrochloride: 2-5 years 5 mg 4-6 hourly to a Max daily dose of 15 mg; 6-12 years 10 mg 4-6 hourly to a Max daily dose of 25 mg. Alternative dosing based on US recommendation: ≥2 years 0.25-0.5 mg/kg (Max: 25 mg/dose) 4-6 hourly as needed; in some patients, doses up to 1.1 mg/kg may be necessary. Use the lowest effective dose. Dosage recommendations and approved age groups may vary among countries and between individual products (refer to local or specific product guidelines).

Rectal
Motion sickness
Adult: As promethazine hydrochloride supp: Initially, 25 mg 30-60 minutes before travelling, may be repeated 8-12 hours later if needed. On subsequent travel days, 25 mg bid may be given if needed.

Rectal
Sedation
Adult: For night-time or pre- or post-operative sedation: As promethazine hydrochloride supp: 25-50 mg. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Rectal
Allergic conditions
Adult: As promethazine hydrochloride supp: 25 mg at bedtime. Alternatively, 12.5 mg before meals and at bedtime, if necessary. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Rectal
Nausea and vomiting
Adult: As promethazine hydrochloride supp: 12.5-25 mg 4-6 hourly as needed.
What are the brands available for Promethazine in Malaysia?
Other Known Brands
  • CCM Promethazine
  • Pharmaniaga Promethazine
  • Promene
  • Promethazine DHA
  • Promethazine-Bodene
  • Votazine
  • Xepagan/Xepagan-5
See more
Administration
Promethazine May be taken with or without food.
Reconstitution
IV inj: Dilute the 25 mg/mL solution to 10 times its volume with sterile water for inj. Instructions for dilution may vary among countries and between individual products (refer to specific product guidelines).
Incompatibility
As promethazine hydrochloride: Incompatible with aminophylline, barbiturates, benzylpenicillin salts, carbenicillin Na, chlorothiazide Na, chloramphenicol Na succinate, cefmetazole Na, cefoperazone Na, cefotetan Na, dimenhydrinate, furosemide, heparin Na, hydrocortisone Na succinate, liposomal doxorubicin hydrochloride, methicillin Na, morphine sulfate, nalbuphine hydrochloride, certain contrast media and parenteral nutrient solutions. Alkaline substances precipitate the insoluble promethazine base.
Contraindications
Coma, CNS depression of any cause. Use in the treatment of lower respiratory tract symptoms, including asthma. Concurrent use with or within 14 days of discontinuing MAOIs. Administration using intra-arterial or SC inj. Children <2 years of age due to the risk of respiratory depression. In some countries, oral promethazine may be contraindicated in children <6 years of age due to the risk of psychiatric and CNS events (refer to local or specific product guidelines).
Special Precautions
Patient with bone marrow depression, CV disease (e.g. severe coronary artery disease), narrow-angle glaucoma, myasthenia gravis, Parkinson's disease; seizure disorder or predisposition to seizures (e.g. history of seizures, brain damage, head trauma, alcoholism, concomitant use with drugs that may affect seizure threshold); urinary retention, benign prostatic hyperplasia, bladder neck obstruction; pyloroduodenal obstruction, stenosing peptic ulcer. Patient subjected to strenuous exercise, heat exposure, and dehydration. Avoid use in patients with compromised respiratory function or who are at risk for respiratory failure (e.g. COPD, sleep apnoea) and in children who have signs and symptoms suggestive of Reye's syndrome or hepatic disease. Promethazine may delay the diagnosis of intestinal obstruction or raised intracranial pressure due to suppression of vomiting and may mask the warning signs of ototoxicity caused by ototoxic drugs (e.g. salicylates). Avoid extravasation when IV administration is used. Renal and hepatic impairment. Children (≥2 years) and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Anticholinergic effects (e.g. blurred vision, dry eye, confusion, constipation, urinary retention, xerostomia); CNS depression (e.g. drowsiness, dizziness, delirium, motor dysfunction, sedation); extrapyramidal symptoms (e.g. tardive dyskinesia, akathisia, acute dystonia, drug-induced parkinsonism); orthostatic hypotension; leucopenia, agranulocytosis; may decrease seizure threshold; may prolong QT interval; cholestatic jaundice, photosensitivity, impaired core body temperature regulation, thickened or dry lung secretions; severe chemical irritation and tissue damage, including necrosis, gangrene, or thrombophlebitis (parenteral). May increase the risk of psychiatric and CNS events (e.g. restlessness, aggression, hallucinations), particularly when oral promethazine is used in children <6 years of age.
Blood and lymphatic system disorders: Aplastic anaemia, thrombocytopenia, thrombocytopenic purpura. Rarely, haemolytic anaemia.
Cardiac disorders: Palpitations.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Diplopia.
Gastrointestinal disorders: Epigastric irritation, nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Rarely, anaphylaxis.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Headache.
Psychiatric disorders: Disorientation, nightmares, euphoria, hysteria.
Respiratory, thoracic and mediastinal disorders: Nasal congestion.
Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus.
Vascular disorders: Hypotension, hypertension.
Potentially Fatal: NMS; respiratory depression (particularly in children <2 years of age).
IM/IV/Parenteral/PO/Rectal: C
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight or UV light during or shortly after treatment.
Monitoring Parameters
Monitor mental status and relief of symptoms. Closely monitor for signs and symptoms of tissue damage during parenteral administration. Observe for CNS effects (e.g. akathisia, delirium, extrapyramidal symptoms, sedation), bradycardia, gastrointestinal upset, urinary retention, blurred vision, and respiratory depression.
Overdosage
Symptoms: Combinations of excitation, ataxia, incoordination, athetosis, hallucinations, intellectual disability and cognition deficit may occur in children <6 years of age. CNS depression (including drowsiness) is more common in adults, progressing to respiratory failure or CV collapse. Convulsions may occur in both adults and children and may be preceded by coma or excitement. Tachycardia and ventricular arrhythmias (e.g. QT prolongation, torsades de pointes) may also occur. Management: Supportive and symptomatic treatment. Following acute ingestion, gastric lavage may be performed and administration of activated charcoal may be considered. Maintain adequate respiratory and circulatory status. Administer diazepam or any suitable anticonvulsant to treat convulsions. Correct acidosis and electrolyte loss. In case of hypotension, treatment of choice is IV fluids, accompanied by repositioning if necessary. If vasopressors are considered for severe cases that do not respond to IV fluids and repositioning, consider administration of norepinephrine or phenylephrine.
Drug Interactions
May enhance the sedative effects of other CNS depressants (e.g. opioid analgesics, general anaesthetics, TCAs, tranquillisers, sedatives or hypnotics including barbiturates). May enhance the action of other anticholinergic agents (e.g. atropine). Increased risk of QT prolongation with drugs known to cause QT prolongation (e.g. antiarrhythmics, antimicrobials, antidepressants). May reverse the vasopressor effects of epinephrine.
Potentially Fatal: Increased risk of NMS with antipsychotics. Increased risk of extrapyramidal effects with MAOIs.
Food Interaction
May enhance the CNS depressant effect of alcohol.
Lab Interference
May cause false-negative or false-positive results with hCG-based pregnancy tests; increased serum glucose levels with glucose tolerance tests; and false-positive results with urine detection of amphetamine/methamphetamine. May alter the flare response to intradermal allergen tests, thereby causing false-negative results; discontinue use at least 72 hours before conducting tests.
Action
Description:
Mechanism of Action: Promethazine, a phenothiazine derivative, is an antihistamine with antimuscarinic, significant sedative, and some serotonin-antagonist properties. It competes with histamine for the H1-receptor sites on effector cells, reduces the stimuli to the brainstem reticular system, and causes an antiemetic activity that may be associated with its muscarinic-blocking effect. Additionally, it blocks the postsynaptic mesolimbic dopaminergic receptors in the brain, exhibits a strong α-adrenergic blocking activity, and reduces the release of hypothalamic and hypophyseal hormones.
Onset: Oral, IM: Approx 20 minutes; IV: Approx 5 minutes.
Duration: 4-6 hours (up to 12 hours).
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract and after IM inj. Bioavailability: Approx 25% (oral); 21.7-23.4% (rectal). Time to peak plasma concentration: 2.8 ± 1.4 hours (oral syrup); 8.2 ± 3.4 hours (rectal).
Distribution: Widely distributed in the body. Crosses the blood-brain barrier and placenta; enters breast milk (small amounts). Volume of distribution: 13.4 ± 3.6 L/kg. Plasma protein binding: 76-93%.
Metabolism: Extensively metabolised in the liver via hydroxylation by CYP2D6 and N-demethylation by CYP2B6 to promethazine sulfoxide and N-desmethylpromethazine; undergoes significant first-pass effect.
Excretion: Via urine and faeces (mainly as inactive metabolites). Elimination half-life: Oral syrup, supp: 16-19 hours (range: 4-34 hours); IV: 9-16 hours; IM: Approx 10 hours.
Chemical Structure

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
Tab/Oral solution/Syrup/Solution for inj: Store below 30°C. Protect from light. Supp: Store between 2-8°C. Storage recommendations may vary between individual products (refer to specific product guidelines).
MIMS Class
Antiemetics / Antihistamines & Antiallergics
ATC Classification
R06AD02 - promethazine ; Belongs to the class of phenothiazine derivatives used as systemic antihistamines.
References
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Anon. Promethazine Hydrochloride (Antihistamine). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 31/05/2024.

Anon. Promethazine Hydrochloride (Sedative). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 31/05/2024.

Buckingham R (ed). Promethazine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/05/2024.

Joint Formulary Committee. Promethazine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/05/2024.

Joint Formulary Committee. Promethazine Teoclate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/05/2024.

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Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics. Phenergan Tablets 10 mg and 25 mg; Phenergan Elixir 5 mg/5 mL data sheet 22 April 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 31/05/2024.

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Phenergan 25 mg/mL Solution for Injection (Opella Healthcare UK Limited, Trading as Sanofi). Medsafe. http://www.medsafe.govt.nz. Accessed 31/05/2024.

Phenergan Elixir 5 mg/5 mL Oral Solution (Opella Healthcare UK Limited, Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 22/07/2024.

Phenergan Night Time 25 mg Film-coated Tablets (Opella Healthcare UK Limited, Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 31/05/2024.

Promene 25 mg Tablet (Noripharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/05/2024.

Promethazine (Oral): Do Not Use in Children Under 6 Years of Age Due to the Risk of Psychiatric and Central Nervous System Side Effects. Medsafe. http://www.medsafe.govt.nz. Accessed 31/05/2024.

Promethazine HCl-Fresenius 50 mg/2 mL Injection (Fresenius Kabi Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/05/2024.

Promethazine Hydrochloride Injection (Hikma Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/07/2024.

Promethazine Hydrochloride Solution (Nostrum Laboratories, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/05/2024.

Promethazine Hydrochloride Suppository (Padagis Israel Pharmaceuticals Ltd). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/05/2024.

Promethazine Hydrochloride Syrup (Wockhardt USA LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/05/2024.

Promethazine Hydrochloride Tablet (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/05/2024.

Promethazine-5 Syrup (Kotra Pharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/07/2024.

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Sominex (Actavis Group PTC ehf). MHRA. https://products.mhra.gov.uk. Accessed 31/05/2024.

Vertigon 25 mg Tablets (Manx Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 31/05/2024.

Votazine Tablet 25 mg (DuoPharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/05/2024.

Disclaimer: This information is independently developed by MIMS based on 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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