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PROMETHAZINE hydrochloride, eq. 25mg/ml base, 2ml, amp.

https://medicalguidelines.msf.org/en/node/1032
https://unicat.msf.org/cat/product/11789
STD DINJPROM5A-

Valid Article

Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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
MF
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
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 hydrochloride

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.