Morphine Sulfate 100 MG Extended Release Oral Capsule Kadian
1 INDICATIONS AND USAGE KADIAN is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve KADIAN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. KADIAN is not indicated as an as-needed (prn) analgesic. KADIAN is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations ( 5.1 ), reserve KADIAN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. KADIAN is not indicated as an as-needed (prn) analgesic.
Allergan, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING KADIAN extended-release capsules contain white to off-white or tan colored polymer coated extended-release pellets of morphine sulfate and are available in nine dose strengths. KADIAN 10 mg KADIAN 20 mg KADIAN 30 mg KADIAN 40 mg Extended-Release capsule Description size 4, light blue opaque cap printed with “KADIAN” and light blue opaque body printed with “10 mg”. size 4, yellow opaque cap printed with “KADIAN” and yellow opaque body printed with “20 mg”. size 4, blue violet opaque cap printed with “KADIAN” and blue violet opaque body printed with “30 mg”. size 2, yellow opaque cap printed with “KADIAN” and blue violet opaque body printed with “40 mg”. Bottle Size 60 60 60 60 NDC # NDC 0023-6011-60 NDC 0023-6012-60 NDC 0023-6013-60 NDC 0023-6014-60 KADIAN 50 mg KADIAN 60 mg KADIAN 80 mg Extended-Release capsule Description size 2, blue opaque cap printed with “KADIAN” and blue opaque body printed with “50 mg”. size 1, pink opaque cap printed with “KADIAN” and pink opaque body printed with “60 mg”. size 0, light orange opaque cap printed with “KADIAN” and light orange opaque body printed with “80 mg”. Bottle Size 60 60 60 NDC # NDC 0023-6015-60 NDC 0023-6016-60 NDC 0023-6017-60 KADIAN 10 0 mg KADIAN 200 mg Extended-Release capsule Description size 0, green opaque cap printed with “KADIAN” and green opaque body printed with “100 mg”. size 0, light brown opaque cap printed with “KADIAN” and light brown opaque body printed with “200 mg”. Bottle Size 60 60 NDC # NDC 0023-6018-60 NDC 0023-6019-60 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a sealed tamper-evident, childproof, light-resistant container. Store KADIAN securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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