INN monograph
Dextromethorphan HBR 8mg + Promethazine 4mg/ 5ml
Therapeutic agent (verify pharmacological class) · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [From component 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
- Warnings Liver warning: This product contains acetaminophen.
- Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions.
- Symptoms may inclide: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
- Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug.
- If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
- When using this product, do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts.
- These could be signs of a serious condition.
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
Point of care
Dosing
Adult
Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Safety
Drug interactions
- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Safety
Adverse effects
- [From component Promethazine] Drowsiness
- psychomotor impairment
- anti-muscarinic effects [e.g. urinary retention
- dry mouth
- GI disturbances
- blurred vision]
- allergic reactions
- epileptic form seizure in patients with cerebral cortex focal lesion
- muscle weakness
- tachycardia
- tight chest
- paradoxical CNS stimulation - mostly in children
- thrombo-phlebitis for IV use.
Use
Indications
Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Promethazine): It acts by competing with histamine for H1-receptor sites on effector cells. Its anticholinergic actions give a drying effect on the nasal mucosa.
ADME
Pharmacokinetics & PD
| Onset | Product-specific |
|---|---|
| Duration | Product-specific |
| Route | See product SmPC |
| Elimination | are product-specific. Consider food effects, protein binding, hepatic CYP/UGT |
| Half-life | when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. |
Full PK/PD text
Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[From component 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.
Lactation
[From component 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.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.