tramadol hydrochloride 100 mg
1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablet is 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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride extended-release tablets 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. Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are 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 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tramadol hydrochloride extended-release tablet 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 ) Tramadol hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic. ( 1 )
lupin pharmaceuticals, inc.
ROUND WHITE L 010
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE extended-release tablets USP are supplied in the following package and dose strength forms: 100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side. Bottles of 30 tablets: NDC 68180-697-06 Bottles of 100 tablets: NDC 68180-697-01 Bottles of 500 tablets: NDC 68180-697-02 200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side. Bottles of 30 tablets: NDC 68180-698-06 Bottles of 100 tablets: NDC 68180-698-01 Bottles of 500 tablets: NDC 68180-698-02 300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other side Bottles of 30 tablets: NDC 68180-699-06 Bottles of 100 tablets: NDC 68180-699-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
TRAMADOL HYDROCHLORIDE extended release tablets securely and dispose of properly [ see Patient Counseling Information ( 17 ) ].
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