First-generation antipsychotic (aliphatic phenothiazine) Pregnancy: §4.3/§4.6 — Do not use during pregnancy, especially during the first three months, unless there are compelling reasons; there is insufficient evidence of safety in human pregnancy. Neonates exposed during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder) — monitor newborns carefully. Breast-feeding: promazine should not be used during lactation (lactation is a contraindication).

Promazine hydrochloride

Promazine is a low-potency phenothiazine antipsychotic used mainly for the short-term management of agitation and restlessness, particularly in elderly patients.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Agitation and restlessness: 100 mg to 200 mg

Route: Oral (for oral administration only)

Frequency: Up to four times daily. Dosage intervals are usually six to eight hours, but in some patients a single bedtime dose may be sufficient

Source: UK SPC (eMC) for Promazine Hydrochloride 25 mg/5 ml Oral Syrup, §4.2 (https://www.medicines.org.uk/emc/product/101928/smpc). §4.2 verbatim framing: 'Dosage varies with the individual and the purpose for which the drug is used, so the following dosages are only for general guidance with regard to possible effectiveness and good tolerance. Initial dosages should be low, with increments at frequent, regular intervals until the desired response is obtained... The lowest effective dose should be used. The commencement and increase of dosage should be performed under close supervision.' ELDERLY: 25 mg initially, up to 50 mg, four times a day; the lowest effective dose for the shortest period possible should be used. PAEDIATRIC: §4.2 states 'Promazine is not recommended for children'; §4.3 contraindicates use in children under 5 years of age — no paediatric dose is given in the source, so no per-kg paediatric dose is recorded. Verify any under-18 use against a children's formulary. WITHDRAWAL (§4.4): acute withdrawal symptoms (nausea, vomiting, sweating, insomnia) have been described after abrupt cessation of antipsychotic drugs; gradual withdrawal is advisable. No total daily maximum dose is stated in the retrieved §4.2. The §4.4 text in this bundle was truncated at the source-fetch limit; §4.5 interactions were not retrieved at all.

Dose adjustments

Renal

No renal dose adjustment is stated in §4.2. §4.4 states only: 'Promazine should be used with caution in patients with renal failure.'

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, other phenothiazines or to any of the excipients
Patients in coma or CNS depression
Patients with bone marrow depression
Patients with phaeochromocytoma
Lactation
Pregnancy, especially during the first three months, unless there are compelling reasons
Moderate and severe hepatic impairment
Long QT syndrome
Children under 5 years of age

Side effects

Nervous system: drowsiness, dizziness, headache, sedation, epileptic fits, extrapyramidal symptoms (dystonia, tremor, tardive dyskinesia, akathisia), neuroleptic malignant syndrome
Cardiac: tachycardia, hypotension, ECG changes with QT prolongation and T-wave changes, ventricular arrhythmias (VF, VT — rare), Torsades de pointes, cardiac arrest and sudden unexplained death
Blood and lymphatic: sensitivity reactions including agranulocytosis, leucopenia, haemolytic anaemia
Gastrointestinal/anticholinergic: gastrointestinal disturbances, dry mouth, constipation; urinary hesitancy or retention when due to enlarged prostate
Eye: blurred vision, precipitation of glaucoma, corneal and lens opacities and purplish pigmentation of skin, cornea, conjunctiva and retina
Endocrine/reproductive: menstrual disturbances, galactorrhoea, gynaecomastia, impotence; weight gain. The elderly are particularly susceptible, especially to sedative, hypotensive and temperature-regulation effects

Clinical monograph

How it works

It blocks central dopamine D2 receptors and also antagonises histamine, muscarinic and alpha-adrenergic receptors, giving it strong sedative and autonomic effects relative to its antipsychotic potency.

Prescribing in practice

Sedation and postural hypotension are prominent, increasing the risk of falls in elderly patients who should be treated cautiously.
Antipsychotics are associated with an increased risk of stroke and mortality when used for behavioural symptoms in elderly people with dementia.
It carries the class risks of QT prolongation, extrapyramidal effects and neuroleptic malignant syndrome, with caution needed in cardiovascular and hepatic disease.

Monitoring

Monitor sedation, postural blood pressure, fall risk and for extrapyramidal or neuroleptic malignant features during treatment.

Counselling the patient

This medicine is likely to make you drowsy; do not drive or use machinery until you know how it affects you.
Get up slowly from sitting or lying to reduce dizziness.
Avoid alcohol, which increases drowsiness.

Evidence & guidelines

Caution with antipsychotics in elderly and dementia patients is highlighted by MHRA and NICE guidance on increased stroke and mortality risk.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways