nucynta er tapentadol hydrochloride 200 mg tablet film coated extended release
1 INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve NUCYNTA ER 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. NUCYNTA ER is not indicated as an as-needed (prn) analgesic. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ] , reserve NUCYNTA ER 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. NUCYNTA ER is not indicated as an as-needed (prn) analgesic.
collegium pharmaceutical, inc.
OVAL BLUE OMJ 200
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16 HOW SUPPLIED/STORAGE AND HANDLING NUCYNTA ER tablets are available in the following strengths and packages: 50 mg extended-release tablets are white oblong-shaped with a black print "OMJ 50" on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-058-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-058-01). 100 mg extended-release tablets are light-blue oblong-shaped with a black print "OMJ 100" on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-116-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-116-01). 150 mg extended-release tablets are blue-green oblong-shaped with a black print "OMJ 150" on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-174-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-174-01). 200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print "OMJ 200" on one side, and are available in bottles of 60 with child- resistant closure (NDC 24510-232-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-232-01). 250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print "OMJ 250" on one side, and are available in bottles of 60 with child-resistant closure (NDC 24510-291-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-291-01). Storage and Handling Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15° C - 30°C (59° F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store NUCYNTA ER securely and dispose of properly.
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