hydromorphone 8 mg
1 INDICATIONS AND USAGE Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic 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, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions ( 5.1 ) ] , 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 for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic 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 which can occur at any dosage or duration ( 5.1 ), and because of the greater risks of overdose and death with extended-release/long-acting 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. ( 1 ) Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )
trigen laboratories, llc
ROUND PINK OS 211
OS 211 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
HYDROMORPHONE HYDROCHLORIDE Extended-Release Tablets Strengths Store at 25ºC (77ºF); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. How Supplied Table
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