Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
Physicians Total Care, Inc.
MORPHINE SULFATE
MORPHINE SULFATE 15 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Přečtěte si celý dokument