Narcotic analgesics:

Indications for DEMEROL INJECTION:

For preoperative medication, support of anesthesia, obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Adult Dosage:

Use lowest effective dose for shortest duration. Use IM inj if repeated doses are required; SC inj is suitable for occasional use; if IV inj is required, reduce dose and inject very slowly (preferably in the form of a diluted soln). Individualize. Management of pain: 50–150mg IM or SC every 3 or 4hrs as needed. Withdraw gradually (esp. if opioid-dependent), taper by 25–50% every 2–4 days. Preoperative: 50–100mg IM or SC, 30–90mins before starting anesthesia. Support of anesthesia: give repeated slow IV inj of fractional doses (eg, 10mg/mL) or continuous IV infusion of a diluted solution (1mg/mL). Obstetrical analgesia: 50–100mg IM or SC when pain is regular, may repeat at 1–3hr intervals. Concomitant phenothiazines, other tranquilizers: reduce dose by 25–50%. Concomitant use or discontinuation of CYP2B6/CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). For elderly: use lower end of dosing range.

Children Dosage:

Use lowest effective dose for shortest duration. Use IM inj if repeated doses are required; SC inj is suitable for occasional use; if IV inj is required, reduce dose and inject very slowly (preferably in the form of a diluted soln). Individualize. Management of pain: 0.5–0.8mg/lb IM or SC up to adult dose, every 3 or 4hrs as needed. Withdraw gradually (esp. if opioid-dependent), taper by 25–50% every 2–4 days. Preoperative: 0.5–1mg/lb IM or SC up to adult dose, 30–90mins before starting anesthesia. Concomitant phenothiazines, other tranquilizers: reduce dose by 25–50%. Concomitant use or discontinuation of CYP2B6/CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

DEMEROL INJECTION Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.

Boxed Warning:

Risk of medication errors. Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants. Monoamine oxidase inhibitors (MAOIs) interactions.

DEMEROL INJECTION Warnings/Precautions:

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Ensure accuracy when prescribing, dispensing, and administering oral soln: risk of medication dosing errors due to confusion between mg and mL, and with meperidine solns of different concentrations. Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental ingestion may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Pheochromocytoma. Atrial flutter and other supraventricular tachycardias. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. For IV: use only if a narcotic antagonist and facilities are immediately available to assist and control respiration. Elderly. Cachectic. Debilitated. Labor & delivery: not recommended. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.

DEMEROL INJECTION Classification:

Opioid agonist.

DEMEROL INJECTION Interactions:

See Contraindications. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP2B6 or CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP2B6 or CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May be potentiated by ritonavir (avoid), acyclovir, cimetidine; monitor.

Adverse Reactions:

Lightheadedness, dizziness, sedation, nausea, vomiting, sweating; respiratory depression, severe hypotension, syncope.

REMS:

YES

How Supplied:

Tabs, Oral soln—contact supplier; Single-dose Uni-Amp (0.5mL, 1mL, 1.5mL, 2mL)—25; Multiple-dose vial (30mL, 20mL)—1; Carpuject single-dose cartridge (1mL)—10