tramadol hydrochloride tablet film coated
1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Mylan Institutional Inc.
ROUND WHITE M T7
M T7 ROUND WHITE
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tramadol hydrochloride tablet film coated
mylan institutional inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride Tablets, USP are available containing 50 mg of tramadol hydrochloride, USP. The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and T7 on the other side. They are available as follows: NDC 51079-991-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.
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