meperidine hydrochloride

FDA Drug Profile

Drug Details

Generic Name
meperidine hydrochloride
Brand Names
N/A
Application Number
Sponsor
SpecGx LLC
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
MEPERIDINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Meperidine hydrochloride tablets are indicated for the management of acute 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2) ], reserve opioid analgesics, including meperidine hydrochloride 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. Meperidine hydrochloride tablets should not be used for treatment of chronic pain. Use of meperidine hydrochloride tablets for an extended period of time may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. Meperidine is 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including meperidine hydrochloride 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 , 5.2 ) Meperidine should not be used for the treatment of chronic pain. Use of meperidine for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite normeperidine.