Meperidine

DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DEMEROL Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including DEMEROL Injection, 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 is an opioid agonist with multiple actions qualitatively similar to those of morphine, the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation.

• DEMEROL Injection 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 DEMEROL ‎Injection 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. ‎ • 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.

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

Boxed warning (serious and life-threatening risks from use of demerol): Addiction, Abuse, and Misuse Because the use of DEMEROL 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 and reassess all patients regularly for the development of these behaviors and conditions. • Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or ‎opioid rotation. ‎ • Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Potentially life-threatening condition could result from concomitant serotonergic drug administration.

The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse • Life-Threatening Respiratory Depression • Interactions with Benzodiazepines or Other CNS Depressants • Neonatal Opioid Withdrawal Syndrome • Opioid-Induced Hyperalgesia and Allodynia ‎ • Serotonin Syndrome with Concomitant Use of Serotonergic Drugs • Adrenal Insufficiency • Severe Hypotension • Gastrointestinal Adverse Reactions • Seizures • Withdrawal The following adverse reactions associated with the use of meperidine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 1 includes clinically significant drug interactions with DEMEROL Injection. Table 1: Clinically Significant Drug Interactions with DEMEROL Injection Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute opioid overdose.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).