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24 HR Hydromorphone Hydrochloride 12 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 hydromorphone 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. Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Hydromorphone hydrochloride extended-release tablets are an opioid agonist indicated in opioid-tolerant patients 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. Patients considered opioid tolerant are those who are taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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 hydromorphone 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. Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.

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23 minutes ago ROUND YELLOW EXH 12 24 HR Hydromorphone Hydrochloride 12 MG Extended Release Oral Tablet

ROUND YELLOW EXH 12

16 HOW SUPPLIED/STORAGE AND HANDLING

HYDROMORPHONE HYDROCHLORIDE Extended-Release Tablets Strengths Strength Color Tablet Description Bottle Count NDC 8 mg red round, biconvex, printed with “EXH 8” 100 0406-3308-01 12 mg Dark yellow round, biconvex, printed with “EXH 12” 100 0406-3312-01 16 mg yellow round, biconvex, printed with “EXH 16” 100 0406-3316-01 32 mg white round, biconvex, printed with “EXH 32” 100 0406-3332-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store

HYDROMORPHONE HYDROCHLORIDE extended-release tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .

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