Clinical medicine profile
Diphenhydramine/promethazine/Ammonium chloride/Sodium citrate
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
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 Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Directions ■ if needed, take every 4-6 hours ■ do not take more than 6 doses in 24-hours children under 4 years of age Do not use children 4 to under 6 years of age Do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (5 ml to 10 ml)
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose
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.
Drug interactions
Open multi-drug checker ↗- 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.
Mechanism & disposition
Combination product.
Read complete mechanism
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.
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
[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.
[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.
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.