MORPHINE SULFATE tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Tillgänglig från:

Physicians Total Care, Inc.

INN (International namn):

MORPHINE SULFATE

Sammansättning:

MORPHINE SULFATE 15 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Morphine sulfate extended-release tablets are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. The morphine sulfate extended-release tablets 100 and 200 mg strengths are a high dose, extended-release, oral morphine formulation indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only i

Produktsammanfattning:

Morphine Sulfate Extended-Release Tablets are supplied as follows: 15 mg: Blue, round tablets, debossed “E652” on one side, and “15” on the other side 30 mg: Green, round tablets, debossed “E653” on one side, and “30” on the other side. 60 mg: Orange, capsule-shaped tablets, debossed “E655” on one side, and “60” on the other side. 100 mg: Blue, capsule-shaped tablets, debossed “E658” on one side, and “100” on the other side. Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F). Dispense in a tight, light-resistant container. Healthcare professionals can telephone Endo Pharmaceutical’s Medical Services Department (1-800-462-3636) for information on this product. CAUTION DEA Order Form Required. Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317 ® 2010 Endo Pharmaceuticals Printed in U.S.A. 2006855 / August 2010 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK        74146

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

MORPHINE SULFATE - MORPHINE SULFATE TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
MORPHINE SULFATE
EXTENDED-RELEASE TABLETS
15 MG, 30 MG, 60 MG, 100 MG*, 200 MG*
CII
RX ONLY
*100 AND 200 MG FOR USE IN OPIOID TOLERANT PATIENTS ONLY
WARNING:
MORPHINE SULFATE EXTENDED-RELEASE TABLETS CONTAIN MORPHINE SULFATE, AN
OPIOID AGONIST AND A
SCHEDULE II CONTROLLED SUBSTANCE, WITH AN ABUSE LIABILITY SIMILAR TO
OTHER OPIOID ANALGESICS.
MORPHINE CAN BE ABUSED IN A MANNER SIMILAR TO OTHER OPIOID AGONISTS,
LEGAL OR ILLICIT. THIS
SHOULD BE CONSIDERED WHEN PRESCRIBING OR DISPENSING MORPHINE SULFATE
EXTENDED-RELEASE
TABLETS IN SITUATIONS WHERE THE PHYSICIAN OR PHARMACIST IS CONCERNED
ABOUT AN INCREASED RISK
OF MISUSE, ABUSE, OR DIVERSION.MORPHINE SULFATE EXTENDED-RELEASE
TABLETS ARE AN EXTENDED-
RELEASE ORAL FORMULATION OF MORPHINE SULFATE INDICATED FOR THE
MANAGEMENT OF MODERATE TO
SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS
NEEDED FOR AN
EXTENDED PERIOD OF TIME.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE NOT INTENDED FOR USE AS
A PRN ANALGESIC.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS 100 AND 200 MG ARE FOR USE
IN OPIOID-
TOLERANT PATIENTS ONLY. THESE TABLET STRENGTHS MAY CAUSE FATAL
RESPIRATORY
DEPRESSION WHEN ADMINISTERED TO PATIENTS NOT PREVIOUSLY EXPOSED TO
OPIOIDS.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED
WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED.
TAKING BROKEN, CHEWED, DISSOLVED, OR CRUSHED MORPHINE SULFATE
EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION
OF A POTENTIALLY FATAL DOSE OF MORPHINE.
DESCRIPTION
Chemically, morphine sulfate is 7, 8-didehydro-4,
5α-epoxy-17-methylmorphinan-3, 6α-diol sulfate
(2:1) (salt) pentahydrate. The molecular formula is (C
H NO ) •H SO •5H O; and the molecular
weight is 758.83. The structural formula is as follows:
Each morphine sulfate extended-release tablet, for oral
administration, contains 15 mg, 30 mg, 60 mg,
100 mg, or 200 mg of morphine sulfate. In addition, each tablet
contains