Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)
ETHEX Corporation
MORPHINE SULFATE
MORPHINE SULFATE 15 mg
ORAL
PRESCRIPTION DRUG
Morphine sulfate extended-release tablets are a controlled-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 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations 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 to 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 onl
Morphine sulfate extended-release 15 mg tablets are oval, film-coated, green tablets, debossed “E” on one side and “15” on the other side, packaged as follows: NDC 58177-310-04 bottle of 100 tablets NDC 58177-310-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 30 mg tablets are oval, film-coated, pink tablets, debossed “E” on one side and “30” on the other side, packaged as follows: NDC 58177-320-04 bottle of 100 tablets NDC 58177-320-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 60 mg tablets are oval, film-coated, white tablets, debossed “E” on one side and “60” on the other side, packaged as follows: NDC 58177-330-04 bottle of 100 tablets NDC 58177-330-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 100 mg tablets are oval, film-coated, gray tablets, debossed “E” on one side and “100” on the other side, packaged as follows: NDC 58177-340-04 bottle of 100 tablets NDC 58177-340-09 bottle of 1000 tablets NDC 58177-340-11 unit dose package of 100 tablets (10 tablets per blister card) Morphine sulfate extended-release 200 mg tablets are oval, film-coated, brown tablets, debossed “E” on one side and “200” on the other side, packaged as follows: NDC 58177-380-04 bottle of 100 tablets NDC 58177-380-09 bottle of 1000 tablets NDC 58177-380-11 unit dose package of 100 tablets (10 tablets per blister card) Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant and child-resistant containers as defined in the USP. Healthcare professionals can telephone ETHEX Corporation’s Medical Affairs Department (1-800-321-1705) for information on this product. CAUTION DEA Order Form Required. Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis,MO 63044 P5694 11/07
Abbreviated New Drug Application
MORPHINE SULFATE - MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ETHEX CORPORATION ---------- CII MORPHINE SULFATE EXTENDED-RELEASE TABLETS 15 MG, 30 MG, 60 MG, 100 MG* AND 200 MG* *100 MG AND 200 MG ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY RX ONLY P5694 11/07 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 A CONTROLLED-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 100 MG AND 200 MG TABLETS 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 and has the following structural formula: Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (m Lesen Sie das vollständige Dokument