HYDROMORPH.IR - 8MG TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

HYDROMORPHONE HYDROCHLORIDE

متاح من:

PURDUE PHARMA

ATC رمز:

N02AA03

INN (الاسم الدولي):

HYDROMORPHONE

جرعة:

8MG

الشكل الصيدلاني:

TABLET

تركيب:

HYDROMORPHONE HYDROCHLORIDE 8MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

50

نوع الوصفة الطبية :

Narcotic (CDSA I)

المجال العلاجي:

OPIATE AGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0108698005; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2012-08-02

خصائص المنتج

PRODUCT MONOGRAPH
N
HYDROMORPH•IR
®
HYDROMORPHONE HYDROCHLORIDE TABLETS
2, 4 AND 8 MG
PURDUE PHARMA STD.
OPIOID ANALGESIC
ATC: N02AA03
Purdue Pharma
575 Granite Court
Pickering, Ontario
L1W 3W8
DATE OF REVISION:
August 20, 2009
Control No.: 130742
Page 2 of 35
PRODUCT MONOGRAPH
NAME OF DRUG
N
HYDROMORPH•IR
®
Hydromorphone Hydrochloride Tablets
2, 4 and 8 mg
THERAPEUTIC CLASSIFICATION
Opioid Analgesic
ACTIONS
Hydromorphone, a semi-synthetic μ opioid agonist, is a hydrogenated
ketone of morphine and shares
the pharmacologic properties typical of opioid analgesics.
Hydromorphone and related opioids
produce their major effects on the central nervous system and
gastrointestinal tract. These include
analgesia, drowsiness, mental clouding, changes in mood, euphoria or
dysphoria, respiratory
depression, cough suppression, decreased gastrointestinal motility,
nausea, vomiting, increased
cerebrospinal fluid pressure, increased biliary pressure, pinpoint
constriction of the pupils, increased
parasympathetic activity and transient hyperglycemia.
Estimates of the relative analgesic potency of parenterally
administered hydromorphone to morphine
in acute pain studies in man range from approximately 7:1 to 11:1.
HYDROMORPH•IR
® (HYDROMORPHONE HYDROCHLORIDE TABLETS)
PRODUCT MONOGRAPH
Page 3 of 35
The relationship between plasma concentration of hydromorphone and
analgesic effect has not been
well established. In patients with chronic pain, hydromorphone should
be titrated to the dose
required to adequately relieve pain without unmanageable side effects.
There is no intrinsic limit to the analgesic effect of hydromorphone;
like morphine, adequate doses
will relieve even the most severe pain. Clinically however, dosage
limitations are imposed by the
adverse effects, primarily respiratory depression, nausea and
vomiting, which can result from high
doses.
PHARMACOKINETICS
After oral administration of conventional release hydromorphone
tablets, the drug is rapidly
absorbed and, like morphine, undergoes pre-systemic eliminati