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, which can occur at any dosage or duration [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 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. 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, which can occur at any dosage or duration ( 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 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.
Mallinckrodt Inc.
ROUND WHITE 4 M
4 M ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 2 mg are available as a flat faced beveled or radius edge white to off-white tablet with one side debossed “Mâ€; other side debossed “2â€. Bottles of 100................................... NDC 0406-3243-01
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 4 mg are available as a flat faced beveled edge white to off-white tablet with one side debossed “Mâ€; other side debossed “4â€. Bottles of 100................................... NDC 0406-3244-01
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 8 mg are available as a white to off-white arc triangle shaped tablet debossed with a bisected “M†on one side and a split “8†on the other side. Bottles of 100................................... NDC 0406-3249-01 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.
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