Meperidine Hydrochloride 100 MG Oral Tablet
1 INDICATIONS AND USAGE Meperidine Hydrochloride Tablets and Oral Solution 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, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.2 )] , reserve Meperidine Hydrochloride Tablets and Oral Solution 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. Meperidine Hydrochloride Tablets or Oral Solution 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. Meperidine Hydrochloride Tablets or Oral Solution should not be used for the treatment of chronic pain. Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine . Meperidine Hydrochloride Tablets and Oral Solution are opioid agonists indicated for the management of pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ): Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Meperidine Hydrochloride Tablets and Oral Solution 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 ( 1 ) • Have not provided adequate analgesia or are not expected to provide adequate analgesia ( 1 ) Meperidine Hydrochloride Tablets and Oral Solution 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. Meperidine Hydrochloride Tablets and Oral Solution should not be used for the treatment of chronic pain. Use of Meperidine Hydrochloride Tablets and Oral Solution for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.
west-ward pharmaceuticals corp.
ROUND WHITE 54 163
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16 HOW SUPPLIED/STORAGE AND HANDLING
MEPERIDINE HYDROCHLORIDE Tablets, USP 50 mg tablet is supplied as a white, round tablet, scored on one side with “54 879” debossed on the other side. NDC 0054-8595-11: 1 x 25 Unit-Dose (Reverse Numbered) Tablets NDC 0054-4595-25: Bottle of 100 Tablets 100 mg tablet is supplied as a white, round tablet, scored on one side with “54 163” debossed on the other side. NDC 0054-4596-25: Bottle of 100 Tablets
MEPERIDINE HYDROCHLORIDE Oral Solution, USP 50 mg per 5 mL oral solution is supplied as a clear, colorless, slightly viscous (unflavored) solution. NDC 0054-3545-63: Bottle of 500 mL Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store
MEPERIDINE HYDROCHLORIDE Tablets and Oral Solution securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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