24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are 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 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 tablets are not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are 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. ( 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 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. ( 1 ) • Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M T1
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16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride Extended-Release Tablets, USP are available containing 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP. The 100 mg tablets are white to off-white, coated, round, unscored tablets imprinted with M over T1 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4152-93 bottles of 30 tablets The 200 mg tablets are white to off-white, coated, oval, unscored tablets imprinted with MT2 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4153-93 bottles of 30 tablets The 300 mg tablets are white to off-white, coated, capsule shaped, unscored tablets imprinted with MT3 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4154-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see Patient Counseling Information (17) ] . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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