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Morphine Sulfate Extended-Release Tablets - Endo Pharmaceuticals

Morphine Sulfate Extended-Release Tablets - Endo Pharmaceuticals

Morphine Sulfate Extended-Release Tablets - Endo

MORPHINE SULFATE EXTENDED-RELEASE TABLETS Rx only 15 mg, 30 mg, 60 mg, 100 mg*, 200 mg* CII *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, 5 -epoxy-17-methylmorphinan-3, 6 -diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C 17 H 19 NO 3 ) 2 H 2 SO 4 5H 2 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 the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, and stearic acid. The 15 mg, 30 mg, 100 mg, and 200 mg strengths contain FD&C Blue No. 1 Lake; and the 30 mg, 60 mg and 200 mg strengths contain FD&C Yellow No. 6 Lake. 1

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