Indications And Usage

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

Pethidine 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, reserve Pethidine 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.

Pethidine Injection should not be used for treatment of chronic pain. Prolonged Pethidine Injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, nor meperidine.

Administration

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

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.

Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with DEMEROL Injection and adjust the dosage accordingly.

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

Contraindications

Pethidine Injection is contraindicated in patients with:

Significant respiratory depression, Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of having taken an MAOI, Known or suspected gastrointestinal obstruction, including paralytic ileus, Hypersensitivity to meperidine (e.g., anaphylaxis)

Precautions

Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Neonatal Opioid Withdrawal Syndrome, Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4Inhibitors and Inducers, Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, Fatal Interaction with Monoamine Oxidase Inhibitors, Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients, Serotonin Syndrome with Concomitant Use of Serotonergic Drugs, Adrenal Insufficiency, Severe Hypotension, Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness, Risks of Use in Patients with Gastrointestinal Conditions, Increased Risk of Seizures in Patients with Seizure Disorders, Withdrawal, Risks of Driving and Operating Machinery, Risks in Patients with Pheochromocytoma, Risk of Use in Patients with Atrial Flutter and Other Supraventricular Tachycardias, Intravenous Use

Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Neonatal Opioid Withdrawal Syndrome, Interactions with Benzodiazepines or Other CNS Depressants, Adrenal Insufficiency, Severe Hypotension, Gastrointestinal Adverse Reactions, Seizures, Withdrawal

Pregnancy and lactation

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with DEMEROL Injection are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Formal animal reproduction studies have not been conducted with meperidine. Neural tube defects (exencephaly and cranioschisis) have been reported in hamsters administered a single bolus dose of meperidine during a critical period of organogenesis at 0.85 and 1.5 times the total human daily dose of 1200 mg.

Adverse outcomes in pregnancy can occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Renal and liver Impairment

Accumulation of meperidine and/or its active metabolite, nor meperidine, can also occur in patients with hepatic impairment. Elevated serum levels have been reported to cause central nervous system excitatory effects. Meperidine should therefore be used with caution in patients with hepatic impairment. Titrate the dosage of DEMEROL Injection slowly in patients with hepatic impairment and monitor closely for signs of central nervous system and respiratory depression.
Accumulation of meperidine and/or its active metabolite, nor meperidine, can occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment. Titrate the dosage of DEMEROL Injection slowly in patients with renal impairment and monitor closely for signs of central nervous system and respiratory depression.

Laboratory Tests