DEMOTHINE INJECTION 50MGML

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PETHIDINE HYDROCHLORIDE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

PETHIDINE HYDROCHLORIDE

Units in package:

1ml10Units mL

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

Not Applicable

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
[Page 1/2]
[Revision Date: 27.06.2022]
DEMOTHINE INJECTION
DESCRIPTION: DEMOTHINE INJECTION is a clear, colourless and
preservative free liquid.
COMPOSITION:
DEMOTHINE INJECTION 100 MG/2ML: Each ampoule contains Pethidine
Hydrochloride 100 mg per 2ml.
DEMOTHINE INJECTION 50 MG/ML: Each ampoule contains Pethidine
Hydrochloride 50 mg per ml.
PHARMACODYNAMICS: Pethidine is a narcotic analgesic and sedative with
actions quantitatively similar to those of morphine. After parenteral
administration, 75 to 100 mg of
Pethidine has comparable analgesic effects to 10 mg of morphine.
Pethidine has a more rapid onset of action but shorter duration of
analgesic effect than does morphine.
Equiv-analgesic doses of Pethidine Hydrochloride and Morphine Sulphate
produce the same degree of respiratory depression. However, the
duration
of this effect may be shorter with
Pethidine. Its depressant effect of the cough reflex may be less than
morphine at equiv-analgesic doses.
Pethidine has spasmolytic as well as spasmogenic effects and may
produce less constipation than morphine.
PHARMACOKINETICS: Pethidine undergoes rapid first-pass metabolism
after oral administration and although well absorbed from the
gastrointestinal tract, it is considerably less
effective orally than parenterally. Peak analgesia occurs
approximately 40 to 60 minutes after subcutaneous administration and
30 to 50 minutes after intramuscular injection. Analgesia may
persist for 2 to 4 hours.
Pethidine is mainly metabolized in liver, primarily undergoing
hydrolysis to pethidinic acid followed by partial conjugation with
glucuronic acid. Other metabolic pathways include
demethylation to norpethidine, which is hydrolysed to norpethidinic
acid and then conjugated to form the glucuronide. Approximately 5% is
excreted in the urine unchanged with
acidification of the urine enhancing the excretion of unchanged
pethidine.
Pethidine has an average plasma half-life of approximately 6.9 hours,
a volume of distribution of 4 L/kg and is approximately 70%