seglentis celecoxib and tramadol hydrochloride tablet
1 INDICATIONS AND USAGE SEGLENTIS is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. SEGLENTIS contains tramadol hydrochloride, an opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated for the management of acute pain in adults that is 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, which can occur at any dosage or duration ( 5.1 ), reserve SEGLENTIS 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. SEGLENTIS should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve SEGLENTIS 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. SEGLENTIS should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
kowa pharmaceuticals america, inc.
OVAL WHITE CTC 100
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16 HOW SUPPLIED/STORAGE AND HANDLING SEGLENTIS (
CELECOXIB AND TRAMADOL HYDROCHLORIDE) tablets are coated tablets containing celecoxib 56 mg and tramadol hydrochloride 44 mg. The tablets are white to off-white elongated coated tablets debossed with "100 on one side and "CTC" on the other side and are available as follows: Bottles of 35 tablets: NDC 66869-564-35 Bottles of 90 tablets: NDC 66869-564-90 Bottles of 90 tablets (Bottle only): NDC 66869-564-09 Dispense in a tight container. 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] .
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