WHO Model Prescribing Information: Drugs Used in Anaesthesia
(1989; 60 pages) [French] View the PDF document
Table of Contents
View the documentPreface
View the documentIntroduction
Close this folderPremedication
View the documentAtropine
View the documentChloral hydrate
View the documentDiazepam
View the documentPromethazine
Open this folder and view contentsGeneral anaesthetics and oxygen
Open this folder and view contentsLocal anaesthetics
Open this folder and view contentsNon-opioid analgesics
Open this folder and view contentsOpioid analgesics and antagonists
Open this folder and view contentsMuscle relaxants and cholinesterase inhibitors
Open this folder and view contentsBlood substitutes
Open this folder and view contentsSolutions for correcting water and electrolyte imbalance
Open this folder and view contentsAntacid for use in obstetric practice
View the documentAnaesthesia at the District Hospital
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Promethazine

Group: sedative
Tablet: 10 mg, 25 mg (hydrochloride)
Elixir or syrup: 5 mg (hydrochloride) in 5 ml
Injection: 25 mg (hydrochloride)/ml in 2-ml ampoule

General information

Promethazine is an antihistaminic and sedative phenothiazine derivative with antiemetic and anticholinergic properties. It acts for about 12 hours following oral administration and is excreted in the urine, largely as metabolites, within 24 hours.

Clinical information

Uses

Premedication prior to surgical anaesthesia and sedation in obstetrics.

Dosage and administration

Adults: 25 mg i.m. 1 hour prior to induction.
Children over 1 year: 0.5-1 mg/kg orally as syrup or tablet, 1 hour prior to induction.

Contraindications

• Known hypersensitivity to promethazine or to other phenothiazine derivatives (since cross-sensitivity may occur).

• Age under 1 year.

• Impaired consciousness due to cerebral depressants or of other origin.

Precautions

Ambulatory patients should be warned that promethazine may impair their ability to drive or operate machinery for up to 24 hours.

Use in pregnancy and lactation

Promethazine should be used in pregnancy only when the need outweighs any potential risk to the fetus. Sufficient promethazine is excreted in maternal milk to sedate breast-fed infants.

Adverse effects

Adverse effects, which occur less frequently than with other phenothiazines, are usually referable to gastrointestinal irritation, allergic phenomena and dose-related central and anticholinergic effects.

Gastrointestinal effects include anorexia, nausea, vomiting, epigastric distress, constipation and diarrhoea. They may be attenuated by taking the drug with meals.

Allergic phenomena include urticaria and dermatitis. Agranulocytosis is very rare. Cholestatic jaundice, which is usually reversible on withdrawal of treatment, has been reported.

Central effects include sedation, dizziness, fatigue, insomnia, nightmares, hallucinations, nervousness, tremor, tinnitus, incoordination, diplopia and blurred vision.

Anticholinergic effects include dryness of the mouth, urinary frequency and palpitations.

Drug interactions

The sedative effect of alcohol and other cerebral depressants is augmented.

Concurrent use of epinephrine may result in hypotension and tachycardia due to partial adrenergic blockade.

Overdosage

Serious poisoning is characterized by muscular twitching, convulsions, restlessness, irritability, confusion, hallucinations and coma. Gastric lavage is of value if undertaken within a few hours of ingestion. Emetics may be ineffective. Oxygen and assisted ventilation are required in the event of respiratory depression. Seizures may be controlled with diazepam.

Storage

Promethazine should be stored in well-closed containers protected from light and should not be allowed to freeze. The syrup is less stable than the other dosage forms.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: October 29, 2018