Pethidine Injection BP (Max Health)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pethidine hydrochloride 50 mg/mL

Available from:

Max Health Limited

INN (International Name):

Pethidine hydrochloride 50 mg/mL

Dosage:

5% w/v

Pharmaceutical form:

Solution for injection

Composition:

Active: Pethidine hydrochloride 50 mg/mL Excipient: Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 10 x 1mL, 10 mL

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Macfarlan Smith Ltd

Therapeutic indications:

Pethidine is indicated for short-term (24-36 hours) relief of moderate to severe pain. It can be given via the following routes of administration - intramuscular, subcutaneous, slow intravenous bolus injection, intravenous infusion and patient controlled analgesia (PCA).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10 x 1mL - 10 mL - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10 x 2mL - 20 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-06-29

Summary of Product characteristics

 
0B
DATA SHEET 
1B
PETHIDINE HYDROCHLORIDE 
15B
_PETHIDINE HYDROCHLORIDE SOLUTION FOR INJECTION _
2B
DESCRIPTION 
Chemical name: ethyl 1-methyl-4-phenylpiperidine-4-carboxylate
hydrochloride (MW 283.8). 
_CAS_ Registry Number: _50-13-5_. 

Pethidine Hydrochloride is a white crystalline powder, very soluble in
water and freely soluble 
in alcohol. Pethidine Injection BP is a sterile, clear solution of
Pethidine Hydrochloride BP and 
sodium hydroxide in Water for Injections BP. Pethidine Injection is
available as a 50 mg/1 mL,  
and 100 mg/2 mL solution. 

16B
_PHARMACOLOGY _
Pethidine is a synthetic opioid analgesic which produces a pattern of
effects similar to 
morphine the standard against which opioid analgesics are compared.
In addition to 
analgesia, the effect of pethidine on the central nervous system
causes respiratory 
depression, drowsiness, sedation, change in mood, euphoria,
dysphoria, mental clouding, 
nausea, vomiting, and electroencephalographic changes. Large doses of
pethidine may 
induce excitation or convulsions. Pethidine is not effective in the
management of cough or 
diarrhoea. 
As a general rule, 75 to 100 mg pethidine (parenterally) is equivalent
to 10 mg morphine with 
respect to analgesic effect, euphoria and respiratory depression. 
Pethidine has local anaesthetic activity but may be an irritant when
applied locally. 
Opioids exert their pharmacological actions by interaction with
stereo-specific opiate 
receptors located in the central and peripheral nervous systems. 
17B
_PHARMACOKINETICS _
ABSORPTION: Pethidine may be administered as an intramuscular,
intravenous or 
subcutaneous injection. Variable absorption has been observed in some
cases following 
intramuscular administration. It has been found that 80% or more of a
100 mg dose of 
pethidine administered intramuscularly is absorbed over six hours
with a mean time of 
maximum plasma concentration at approximately 24 minutes. 
Analgesia may persist for two to four hours following