PROMETHAZINE hydrochloride, eq. 25mg/ml base, 2ml, amp.
STD
DINJPROM5A-
Valid Article
Account code:
60000
HS Code:
300490
Last Updated on:
07/11/2024, 18:07:08
Former
Code(s):
-X
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.
PROMETHAZINE hydrochloride
- Not in the WHO list of Essential Medicines 2023 (removed in 2009)
Therapeutic Action
Sedative, antihistaminic, antiemetic
Indications
Agitation or aggressive behaviour in patients with acute or chronic psychosis, in association with haloperidol
Third-line treatment in postoperative nausea and vomiting
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Instructions for use
Must be given as deep IM injection, or possibly as slow IV infusion.
Avoid any risk of error during the administration (extravasation or intra-arterial injection) which may cause necrosis and peripheral gangrene.
NEVER administer by SC route.
Precautions for Use
Administer with caution and under supervision:
- in elderly patients
- in patients with urethro-prostatic disorders, closed-angle glaucoma, epilepsy, orthostatic hypotension, severe hepatic or renal impairment
- in case of concomitant use with CNS depressant drugs (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 known QT interval prolongation or congenital long QT syndrome.
Avoid in pregnant or breast-feeding women.
Storage
- Below 25°C - Protect from sunlight
- After dilution, use the solution immediately.