PROMETHAZINE hydrochloride, eq. 25mg base, tab.

STD DORAPROM2T-

Valid Article

Former Code(s): -X
17.2 - Antiemetic medicines
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
24.1 - Medicines for psychotic disorders
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
R06AD02
Anatomical Therapeutic Chemical Classification according to WHOCC
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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PROMETHAZINE

Therapeutic Action

Sedative, antihistaminic, antiemetic

Indications

Insomnia

Agitation or aggressive behaviour in patients with acute or chronic psychosis, in association with haloperidol

Instructions for use

Precautions for Use

Administer with caution and monitor use:

  • in elderly patients
  • in patients with prostate disorders, closed-angle glaucoma, epilepsy, orthostatic hypotension, severe renal or hepatic impairment
  • in case of concomitant use with CNS depressants (opioid analgesics, antipsychotics, sedatives, antidepressants, etc.) or other anticholinergic drugs (atropine, amitriptyline, chlorpromazine, etc.)

May cause:

  • drowsiness, dizziness, headache, confusion, hypotension, photosensitivity
  • anticholinergic effects (dry mouth, constipation, blurred vision, tachycardia, disorders of micturition)
  • rarely: seizures, extrapyramidal syndrome, neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), allergic reactions

Contraindicated in patients with prolonged QT-interval or with risk factors for QT-interval prolongation.

Avoid in pregnancy and breast-feeding women.

Storage

Below 25°C - Protect from sunlight - Protect from humidity