AbuseDeterrent Morphine Sulfate 30 MG Naltrexone hydrochloride 1.2 MG Extended Release Oral Capsule Embeda
1 INDICATIONS AND USAGE EMBEDA 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. EMBEDA is a combination opioid agonist/opioid antagonist product 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. ( 1 ) 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, reserve EMBEDA 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.( 1 ) EMBEDA is not indicated as an as-needed (prn) analgesic. ( 1 ) 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 EMBEDA 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. EMBEDA is not indicated as an as-needed (prn) analgesic.
Pfizer Laboratories Div Pfizer Inc
CAPSULE BLUE Embeda 30
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16 HOW SUPPLIED/STORAGE AND HANDLING EMBEDA 20 mg/0.8 mg EMBEDA 30 mg/1.2 mg EMBEDA 50 mg/2 mg EMBEDA 60 mg/2.4 mg EMBEDA 80 mg/3.2 mg EMBEDA 100 mg/4 mg Morphine sulfate 20 mg 30 mg 50 mg 60 mg 80 mg 100 mg Sequestered naltrexone hydrochloride 0.8 mg 1.2 mg 2 mg 2.4 mg 3.2 mg 4 mg Extended-Release capsule Description For all strengths, the darker-toned cap has "EMBEDA" printed in grey ink and a single grey band around ¾ of the circumference. Two-toned, yellow opaque hard gelatin capsule. The lighter-toned body has "20" reverse-printed in a grey circle. Two-toned, blue-violet opaque hard gelatin capsule. The lighter-toned body has "30" reverse-printed in a grey circle. Two-toned, blue opaque hard gelatin capsule. The lighter-toned body has "50" reverse-printed in a grey circle. Two-toned, pink opaque hard gelatin capsule. The lighter-toned body has "60" reverse-printed in a grey circle. Two-toned, light peach opaque elongated hard gelatin capsule. The lighter-toned body has "80" reverse-printed in a grey circle. Two-toned, green opaque hard gelatin capsule. The lighter-toned body has "100" reverse-printed in a grey circle. Bottle Size 75 cc 75 cc 75 cc 75 cc 75 cc 75 cc Bottle Count 30 capsules 30 capsules 30 capsules 30 capsules 30 capsules 30 capsules NDC # 60793-430-20 60793-431-20 60793-433-20 60793-434-20 60793-435-20 60793-437-20 Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a sealed, tamper-evident, childproof, light-resistant container. Store EMBEDA securely and dispose of properly [see Patient Counseling Information (17) ] .
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