hydromorphone hydrochloride tablet
1 INDICATIONS AND USAGE Hydromorphone hydrochloride tablets are indicated 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 ( 5.2 )] , reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated 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, reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia
lannett company, inc.
ROUND WHITE LCI 1355
LCI 1355 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Hydromorphone Hydrochloride Tablets USP, 2 mg are white, round, flat-faced beveled edge tablets debossed with “LCI†over “1353†on one side and “2†on the other side. Available in bottles of 100 (NDC 0527-1353-01). Hydromorphone Hydrochloride Tablets USP, 4 mg are white, round, flat-faced beveled edge tablets debossed with “LCI†over “1354†on one side and “4†on the other side. Available in bottles of 100 (NDC 0527-1354-01). Hydromorphone Hydrochloride Tablets USP, 8 mg are white, round, flat-faced beveled edge, scored, tablets debossed with “LCI†over “1355†on one side and plain on the other side. Available in bottles of 100 (NDC 0527-1355-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Store hydromorphone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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