Clinical medicine profile
Paracetamol / Promethazine
Non-opioid analgesic / antipyretic
- Route
- ORAL / RECTAL / IV
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [Paracetamol] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid. [Promethazine] CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age.
- Promethazine HCl Suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
- Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
Precautions
- [From component Paracetamol] Risk of severe hepatotoxicity in overdose.
- Chronic high-dose use, malnutrition, enzyme-inducing drugs, and alcohol increase risk.
- Check total daily intake from all sources.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
Use, effects & interactions
Indications
- Therapeutic use is agent- and indication-specific within the class (Non-opioid analgesic / antipyretic).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
Adverse effects
- [Paracetamol] Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP). [Promethazine] ADVERSE REACTIONS Central Nervous System - Drowsiness is the most prominent CNS effect of this drug.
- Sedation, somnolence, blurred vision, dizziness
- confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion
- lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria and hallucinations have also been reported.
- Cardiovascular - Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
- Dermatologic - Dermatitis, photosensitivity, urticaria.
- Hematologic - Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
- Gastrointestinal - Dry mouth, nausea, vomiting, jaundice.
- Respiratory - Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal).
- (See WARNINGS - Respiratory Depression ).
- Other - Angioneurotic edema.
- Neuroleptic malignant syndrome (potentially fatal) has also been reported.
- (See WARNINGS – Neuroleptic Malignant Syndrome ).
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Paracetamol, Promethazine.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Combination product.
Read complete mechanism
Combination product. Component mechanism (Paracetamol): Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2.
30–60 minutes oral
4–6 hours
ORAL / RECTAL / IV
(glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted.
~2–3 h; prolonged in liver disease/overdose.
Pregnancy, lactation & diet
[Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration. [Promethazine] Pregnancy: Teratogenic Effects: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
[Promethazine] Nursing Mothers - It is not known whether promethazine HCl is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine HCl Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.