WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] . Addiction, Abuse, and Misuse Because the use of Meperidine Hydrochloride Tablets and Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.2 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Meperidine Hydrochloride Tablets and Oral Solution, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Meperidine Hydrochloride Tablets and Oral Solution are essential [see Warnings and Precautions ( 5.3 )]. Accidental Ingestion Accidental ingestion of Meperidine Hydrochloride Tablets and Oral Solution, especially by children, can result in a fatal overdose of meperidine [see Warnings and Precautions ( 5.3 )] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Meperidine Hydrochloride Tablets and Oral Solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.5 )] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions ( 5.6 )]. Cytochrome P450 3A4 (CYP3A4) Interaction The concomitant use of Meperidine Hydrochloride Tablets and Oral Solution with all cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions ...
Adult Dosing
General dosing
Meperidine Hydrochloride Tablets and Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Meperidine Hydrochloride Tablets and Oral Solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
General dosing
Adult Patients : Initiate treatment in adults with 50 mg to 150 mg orally, every 3 to 4 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia . Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. •
General dosing
Dosage Adults Initiate treatment with Meperidine Hydrochloride Tablets or Oral Solution in a dosing range of 50 mg to 150 mg (5 mL to 15 mL) orally, every 3 or 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets or Oral Solution. • Pediatric Patients Initiate treatment with Meperidine Hydrochloride Tablets or Oral Solution in a dosing range of 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as needed, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets or Oral Solution. 2.4 Dosage Modification with Concomitant Use with Phenothiazines The dose of meperidine should be reduced by 25% to 50% when administered concomitantly with phenothiazines and other tranquilizers. 2.5 Titration and Maintenance of Therapy Individually titrate Meperidine Hydrochloride Tablets and Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions.
Pediatric Dosing
General dosing
Pediatric Patients : Initiate treatment in pediatric patients with 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 to 4 hours as needed, at the lowest dose necessary to achieve adequate analgesia . Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. • Periodically reassess patients receiving Meperidine Hydrochloride Tablets or Oral Solution to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse . • Do not rapidly reduce or abruptly discontinue Meperidine Hydrochloride Tablets and Oral Solution in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
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