PROMAZINE HYDROCHLORIDE Oral syrup Ref.[8319] Active ingredients: Promazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE

Therapeutic indications

  1. As an adjunct to short-term management of moderate to severe psychomotor agitation.
  2. Agitation and restlessness in the elderly.

Posology and method of administration

Posology

For oral administration only.

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. Dosage intervals are usually six to eight hours, but in some patients the 24 hour requirement may be conveniently administered in a single bedtime dose.

The commencement and increase of dosage should be performed under close supervision.

Psychomotor Agitation

Adults: 100mg to 200mg, four times daily.

Elderly: Half the normal starting dose may be sufficient for a therapeutic response.

Agitation and Restlessness

Elderly: 25mg initially, increasing, if necessary, up to 50mg, four times a day.

Paediatric population

Children: Promazine is not recommended for children.

Overdose

Ingestion of large amounts of Promazine is followed by deep sleep, with or without a pronounced fall in blood pressure and without particular change in respiration rate, other than the slowing attendant upon sedation. Occasionally an initial period of excitement may precede coma, followed by grand mal seizures.

In the absence of any specific antidote, treatment should be based on ordinary therapeutic principles with special emphasis on the following measures:

  • Gastric lavage;
  • Treat convulsions if present;
  • Correction of acute hypotension if necessary;
  • Counteraction of the effects of an excess of Promazine on the central nervous system;
  • Control and natural recovery of hypothermia.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store below 25°C. Protect from light.

Nature and contents of container

Bottle: Amber (type III) glass bottle

Capacity: 150ml

Closure: HDPE, EPE wadded, tamper evident, child resistant closure.

Special precautions for disposal and other handling

Dispense in amber glass bottles. If a dose of under 5ml is required, the oral syrup should be administered using an oral dosing device.

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