Meperidine Oral Solution Dosage & Rx Info

Meperidine Oral Solution Generic Name & Formulations

Legal Class

CII

General Description

Meperidine HCl 50mg/5mL; alcohol-free; banana flavor.

Pharmacological Class

Opioid agonist.

How Supplied

Tabs, Oral soln—contact supplier; NexJect single-dose prefilled syringe (1mL), Carpuject single-dose cartridge (1mL)—10; Multiple-dose vial (30mL)—1

Manufacturer

Hikma Pharmaceuticals

Mechanism of Action

Meperidine is an opioid agonist with multiple actions involving the CNS and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation.

Meperidine Oral Solution Indications

Indications

Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration), reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, opioid combination products) are not tolerated or inadequate to provide analgesia. Should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Use for an extended perioid of time may increase the risk of toxicity (eg, seizures) from the accumulation of the meperidine metabolite, normeperidine.

Meperidine Oral Solution Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Oral soln: use calibrated measuring device; dilute each dose in ½ glass of water. Individualize. Initially 50–150mg every 3–4 hours as needed. If pain relief inadequate with ≤600mg/day, taper dose and discontinue; use alternative. 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). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children

Use lowest effective dose for shortest duration. Oral soln: use calibrated measuring device; dilute each dose in ½ glass of water. Individualize. Initially 1.1–1.8mg/kg up to adult dose every 3–4 hours as needed. If pain relief inadequate with ≤600mg/day, taper dose and discontinue; use alternative. 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). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Meperidine Oral Solution Contraindications

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.

Meperidine Oral Solution Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of meperidine: Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with MAO inhibitors, CYP3A4 inhibitors/inducers, benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome.

Meperidine Oral Solution Warnings/Precautions

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 esp. during initiation or following dose increases. Accidental ingestion may cause fatal overdose (esp. in children). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. 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. Monitor for signs of hypotension when initiating or titrating dose. 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.

REMS

YES

Meperidine Oral Solution Pharmacokinetics

Metabolism

Hepatic (CYP3A4, CYP2B6).

Elimination

Renal. Half-life: 2–5 hours.

Meperidine Oral Solution Interactions

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.

Meperidine Oral Solution Adverse Reactions

Adverse Reactions

Lightheadedness, dizziness, sedation, nausea, vomiting, sweating; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Meperidine Oral Solution Clinical Trials

See Literature

Meperidine Oral Solution Note

Notes

Formerly known under the brand name Demerol.

Meperidine Oral Solution Patient Counseling