morphine sulfate 60 mg tablet film coated extended release
INDICATIONS AND USAGE 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 only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).
ethex corporation
OVAL WHITE E 60
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HOW SUPPLIED 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
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