hydromorphone hydrochloride
hydromorphone hydrochloride is listed in the FDA National Drug Code directory with 27 NDC codes, marketed under brand names including HYDROMORPHONE HYDROCHLORIDE, Hydromorphone Hydrochloride, Dilaudid. Available dosage forms: tablet, solution, tablet, extended release.
Drug Details
- Generic Name
- hydromorphone hydrochloride
- Brand Names
- HYDROMORPHONE HYDROCHLORIDE, Hydromorphone Hydrochloride, Dilaudid, hydromorphone hydrochloride
- Application Number
- ANDA210506
- Sponsor
- Ascent Pharmaceuticals Inc
- NDC Codes
- 27
- Dosage Forms
- TABLET, SOLUTION, TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- HYDROMORPHONE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.1)] , reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options 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 opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options 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)