MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE- meperidine hydrochloride injection
Hikma Pharmaceuticals USA Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and MONOAMINE OXIDASE (MAO) INHIBITORS INTERACTIONS

Addiction, Abuse, and Misuse

Meperidine Hydrochloride Injection 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 Meperidine Hydrochloride Injection, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Meperidine Hydrochloride Injection. Monitor for respiratory depression, especially during initiation of Meperidine Hydrochloride Injection or following a dose increase [see Warnings and Precautions (5.2) ].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Meperidine Hydrochloride Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3) ].

Cytochrome P450 3A4 Interaction

The concomitant use of Meperidine Hydrochloride Injection with all cytochrome P450 3A4 inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in meperidine plasma concentration. Monitor patients receiving Meperidine Hydrochloride Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7)].

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 [see Warnings and Precautions (5.5), Drug Interactions (7)].

  • Reserve concomitant prescribing of Meperidine Hydrochloride Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosage and duration to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Concomitant Use of Meperidine Hydrochloride Injection with Monoamine Oxidase (MAO) Inhibitors

Concomitant use of Meperidine Hydrochloride Injection with monoamine oxidase (MAO) inhibitors can result in coma, severe respiratory depression, cyanosis, and hypotension. Use of Meperidine Hydrochloride Injection with MAO inhibitors within last 14 days is contraindicated [see Contraindications (4), Warnings and Precautions (5.6), Drug Interactions (7)].

1 INDICATIONS AND USAGE

Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia.

Meperidine Hydrochloride Injection is indicated for the management of 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, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Meperidine Hydrochloride Injection 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 Injection should not be used for treatment of chronic pain. Prolonged Meperidine Hydrochloride Injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].

Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with Meperidine Hydrochloride Injection and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

Parenteral drug products should be inspected visually for particulate and discoloration prior to administration whenever solution and container permit.

2.2 For Management of Pain

I nitial Dosage

Dosage should be adjusted according to the severity of the pain and the response of the patient. While subcutaneous administration is suitable for occasional use, intramuscular administration is preferred when repeated doses are required. If intravenous administration is required, dosage should be decreased and the injection made very slowly, preferably utilizing a diluted solution.

Adults: The usual dosage is 50 mg to 150 mg intramuscularly or subcutaneously every 3 or 4 hours as needed for pain. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children: The usual dosage is 0.5 mg/lb to 0.8 mg/lb intramuscularly or subcutaneously up to the adult dose, every 3 or 4 hours as necessary.

Titration and Maintenance of Therapy

Individually titrate Meperidine Hydrochloride Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Meperidine Hydrochloride Injection to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the health and care team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Meperidine Hydrochloride Injection dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

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