M-ESLON CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MORPHINE SULFATE

Available from:

ETHYPHARM INC

ATC code:

N02AA01

INN (International Name):

MORPHINE

Dosage:

15MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

MORPHINE SULFATE 15MG

Administration route:

ORAL

Units in package:

20/50

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0104545009; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-04-07

Summary of Product characteristics

_N_
_M-ESLON_
_® _
_(morphine sulfate) Product Monograph _
PRODUCT MONOGRAPH
N
M-ESLON
®
(Morphine Sulfate)
10 mg, 15 mg, 30 mg, 60 mg, 100 mg, 200 mg
Extended Release Capsules
Narcotic Analgesic
Ethypharm Inc.
1000 de la Gauchetière Ouest, Suite 2400
Date of Revision: June 11, 2019
Montréal, Québec, H3B 4W5
Submission Control No. 226278
_ _
_N_
_M-ESLON_
_® _
_(morphine sulfate) Product Monograph _
_Page 2 of 38 _
ACTIONS
Morphine is a narcotic 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 to 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. Abou