ZOMORPH CAPSULE (SUSTAINED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

MORPHINE SULFATE

Disponible des:

ETHYPHARM INC

Codi ATC:

N02AA01

Designació comuna internacional (DCI):

MORPHINE

Dosis:

20MG

formulario farmacéutico:

CAPSULE (SUSTAINED-RELEASE)

Composición:

MORPHINE SULFATE 20MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0104545002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2005-07-05

Fitxa tècnica

1
PRODUCT MONOGRAPH
ZOMORPH
®
(Morphine sulfate)
20, 40, 60, 120 and 200 mg
Sustained-release Capsules
Opioid Analgesic
Ethypharm Inc.,
200, boul. Armand-Frappier
Laval, Quebec, H7V 4A6
Control
#
101797
Date of Preparation: December 2005
Date of Revision: January 19, 2006
2
PRODUCT MONOGRAPH
ZOMORPH
®
(Morphine sulfate)
20, 40, 60, 120 and 200 mg
Sustained-release Capsules
OPIOID ANALGESIC
ACTIONS AND CLINICAL PHARMACOLOGY
Morphine is an opioid analgesic, which exerts an agonist effect at
specific, saturable opioid receptors in the
CNS and other tissues. In man, morphine produces a variety of effects
including analgesia, constipation
from decreased gastrointestinal motility, suppression of the cough
reflex, respiratory depression from
reduced responsiveness of the respiratory centre to CO
2
, nausea and vomiting via stimulation of the CTZ,
changes in mood including euphoria and dysphoria, sedation, mental
clouding, and alterations of the
endocrine and autonomic nervous systems.
The psychological effects are of longer duration than that of
analgesia. Morphine-induced analgesia is
relatively selective in that other sensory modalities (touch, vision,
hearing) are not affected. Moderate doses
of morphine are effective in relieving clinical (pathological) pain
and increasing pain threshold to tolerate
pain. The capacity of perceive the sensation of pain may be relatively
unaltered. The analgesic effects of
morphine
are
due
to
its
CNS
action,
i.e,
limbic
system,
hypothalamus,
and
centrally
induced
endocrinological effect. At present, the exact mechanism by which the
opiates exert their effects remains
unknown.
Morphine is readily absorbed from the gastrointestinal tract and after
s.c. or i.m. injection. Due to first-pass
metabolism in the liver, the effect of an oral dose is less than after
parenteral administration. With repeated
regular dosing, orally administered morphine is about one-third as
potent as when given by i.m. injection.
Morphine is primarily excreted in the urine as morphine-3-glucuronide.
About 7 to