oxycodone hydrochloride

FDA Drug Profile — OXYCODONE HYDROCHLORIDE, oxycodone hydrochloride, OxyContin, Roxicodone

Drug Details

Generic Name
oxycodone hydrochloride
Brand Names
OXYCODONE HYDROCHLORIDE, oxycodone hydrochloride, OxyContin, Roxicodone
Application Number
ANDA208593
Sponsor
KVK-Tech, Inc.
NDC Codes
17
Dosage Forms
SOLUTION, TABLET, TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
OXYCODONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-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. Oxycodone 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. 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 (5.1) ], reserve Oxycodone Hydrochloride Tablets, USP 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. Oxycodone 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.