MS CONTIN SUPPOSITORIES - 200MG SUPPOSITORY (SUSTAINED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MORPHINE SULFATE

Tilgængelig fra:

PURDUE PHARMA

ATC-kode:

N02AA01

INN (International Name):

MORPHINE

Dosering:

200MG

Lægemiddelform:

SUPPOSITORY (SUSTAINED-RELEASE)

Sammensætning:

MORPHINE SULFATE 200MG

Indgivelsesvej:

RECTAL

Enheder i pakken:

24 SUPPOSITORIES

Recept type:

Narcotic (CDSA I)

Terapeutisk område:

OPIATE AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0104545013; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2003-07-29

Produktets egenskaber

PRODUCT MONOGRAPH
N
MS CONTIN
®
MORPHINE SULFATE SUSTAINED RELEASE TABLETS
5, 15, 30, 60, 100 AND 200 MG
N
MS CONTIN
® SUPPOSITORIES
MORPHINE SULFATE SUSTAINED RELEASE SUPPOSITORIES
30, 60, 100, 200 AND 300 MG
PURDUE PHARMA STD.
OPIOID ANALGESIC
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
DATE OF REVISION:
Control No. 130745
August 25, 2009
Page 2 of 43
PRODUCT MONOGRAPH
NAME OF DRUG
N
MS CONTIN
®
Morphine Sulfate Sustained Release Tablets
5, 15, 30, 60, 100 and 200 mg
N
MS CONTIN
® SUPPOSITORIES
Morphine Sulfate Sustained Release Suppositories
30, 60, 100, 200 and 300 mg
PHARMACOLOGICAL CLASSIFICATION
Opioid Analgesic
ACTIONS
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 center 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.
Morphine is readily absorbed when given orally, rectally or by 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, oral morphine is about 1/3 as potent as
when given by intramuscular
injection
and
rectal
MS
CONTIN
®
(morphine
sulfate
sustained
release
suppositories)
has
MS CONTIN
® (MORPHINE SULFATE SR TABLETS)
MS CONTIN
® (MORPHINE SULFATE SR SUPPOSITORIES)
PRODUCT MONOGRAPH
Page 3 of 43
approximately 40% the potency of subcutaneous morphine. The rectal
dose of
MS CONTIN
suppositories is approximately equivalent to the oral dose of
MS CONTIN
®
(morphine sulfate
sustained release tablets) after repeated dosing. Morphine is
primarily excreted in the urine as
morphine-3-glucuronide. About 7 to 10% of a