Levomepromazine Hydrochloride

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levomepromazine hydrochloride 25 mg/mL

Available from:

Max Health Limited

INN (International Name):

Levomepromazine hydrochloride 25 mg/mL

Dosage:

25 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Levomepromazine hydrochloride 25 mg/mL Excipient: Ascorbic acid Sodium chloride Sodium sulfite Water for injection

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Indicated in the management of terminal pain and accompanying restlessness or distress.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10 x 1 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2014-11-18

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 9
1 PRODUCT NAME
Levomepromazine hydrochloride 25mg/mL injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless solution contained in a clear glass ampoule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless solution contained in a clear glass ampoule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INJECTION
Levomepromazine hydrochloride is indicated in the management of
terminal pain and accompanying
restlessness or distress.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage varies with the condition and the individual response of the
patient.
TERMINAL ILLNESS
_INJECTION _
_Adults _
The usual dose for adults is 12.5 - 25 mg (0.5 - 1 mL) by the
intramuscular, or after dilution with an equal
volume of normal saline, by the intravenous route.
In cases of severe agitation up to 50 mg (2 mL) may be used, repeated
every 6 - 8 hours.
Levomepromazine may induce postural hypotension requiring close
observation of the patient.
_CONTINUOUS SUBCUTANEOUS INFUSION _
Levomepromazine
hydrochloride may be administered over a 24 hour period with a syringe
driver.
The required dose of levomepromazine
hydrochloride (25 - 200 mg per day) should be diluted with the
calculated volume of normal saline.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to levomepromazine or any of the excipients listed in
section 6.1.
•
Risk of urinary retention related to urethroprostatic disorders.
•
Risk of closed angle glaucoma.
•
History of agranulocytosis.
•
Dopaminergics, except in patients with Parkinson's disease.
Page 2 of 9
•
Safety in pregnancy has not been established. There are no absolute
contraindications to the use of
levomepromazine in terminal care. The medicine should be avoided or
used with caution in patients
with liver dysfunction or cardiac disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Suicide. The possibility of a suicide attempt is inherent in
schizophrenia and bipolar disorder, and close
supervision of high-