• Moderate or severe pain (as monotherapy or in combination with nonopioid agents).
• Anesthesia adjunct.
• Analgesic during labor.
• Preoperative sedation.

Unlabeled Use:

• Rigors.

Contraindicated in:

• Hypersensitivity
• Hypersensitivity to bisulfites (some injectable products)
• Recent (within 14 days) MAO inhibitor therapy
• Severe respiratory impairment
• OB: Labor and delivery
• Lactation: Lactation.

Use Cautiously in:

• Personal or family history of substance use disorder or mental illness
• Head trauma
• ↑intracranial pressure
• Severe renal or hepatic impairment
• Acute asthma attack, COPD, hypoxia, or hypercapnea
• Hypothyroidism
• Adrenal insufficiency
• Debilitated patients (dose ↓ suggested)
• Undiagnosed abdominal pain or prostatic hyperplasia
• Extensive burns
• High-dose or prolonged therapy (>600 mg/day or >2 days; ↑ risk of CNS stimulation and seizures due to accumulation of normeperidine)
• Sickle cell anemia (may require ↓ initial doses)
• OB: Avoid chronic use during pregnancy as can result in neonatal opioid withdrawal syndrome
• Pedi: Syrup contains benzyl alcohol, which can cause gasping syndrome in neonates. Children have ↑ risk of seizures due to accumulation of normeperidine
• Geri: Appears on Beers list. ↑ risk of delirium in older adults. Avoid use in older adults.

CV: hypotension, bradycardia.

Derm: flushing, sweating.

EENT: blurred vision, diplopia, miosis.

Endo: adrenal insufficiency.

GI: constipation, nausea, vomiting.

GU: urinary retention.

Neuro: confusion, sedation, dysphoria, euphoria, floating feeling, hallucinations, headache, SEIZURES, unusual dreams.

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA OR SLEEP-RELATED HYPOXEMIA).

Misc: allodynia, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), opioid-induced hyperalgesia, physical dependence, psychological dependence, tolerance.

Drug-Drug:

• Do not use in patients receiving MAO inhibitors or procarbazine (may cause fatal reaction; contraindicated within 14 days of MAO inhibitor therapy).
• Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
• Administration of mixed agonist/antagonist analgesics, including nalbuphine or butorphanol, or partial agonist analgesics, including buprenorphine, may ↓ meperidine's analgesic effects and/or precipitate opioid withdrawal in physically dependent patients.
• Concurrent use of CYP3A4 inhibitors, including ritonavir, ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, nefazodone, diltiazem, verapamil, nelfinavir, and fosamprenavir, ↑ levels and risk of opioid toxicity; careful monitoring during initiation, dose changes, or discontinuation of the inhibitor is recommended.
• Concurrent use with CYP3A4 inducers, including barbiturates, carbamazepine, efavirenz, corticosteroids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, or rifampin, may ↓ levels and analgesia; if inducers are discontinued or dosage ↓, patients should be monitored for signs of opioid toxicity and necessary dose adjustments should be made.
• Chlorpromazine and thioridazine may ↑ the risk of adverse reactions (concurrent use should be avoided).
• May aggravate side effects of isoniazid.
• Acyclovir may ↑ levels of meperidine and normeperidine.
• Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, TCAs, tramadol, trazodone, mirtazapine, 5-HT₃ receptor antagonists, linezolid, methylene blue, and triptans, ↑ risk of serotonin syndrome.

Drug-Natural Products:

• Concomitant use of kava-kava, valerian, or chamomile can ↓ CNS depression.
• St. John's wort may ↑ serious side effects; concurrent use is not recommended.

(Generic available)

• Tablets: 50 mg; 100 mg;
• Oral solution (banana flavor): 50 mg/5 mL;
• Solution for injection : 25 mg/mL; 50 mg/mL; 75 mg/mL; 100 mg/mL;

• PO (Adults): Analgesia: 50–150 mg every 3–4 hr; may ↑ as needed (not to exceed 600 mg/24 hr).
• IM, SC (Adults): Analgesia: 50–150 mg every 3–4 hr; may ↑ as needed (not to exceed 600 mg/24 hr). Analgesia during labor: 50–100 mg when contractions become regular; may repeat every 1–3 hr. Preoperative sedation: 50–100 mg 30–90 min before anesthesia.
• PO (Children): Analgesia: 1.1–1.8 mg/kg every 3–4 hr (max = 100 mg/dose).
• IM, SC (Children): Analgesia: 1.1–1.8 mg/kg every 3–4 hr (max = 100 mg/dose). Preoperative sedation: 1.1–2.2 mg/kg 30–90 min before anesthesia (not to exceed adult dose).
• IV (Adults): 15–35 mg/hr as a continuous infusion; PCA: 10 mg initially; with a range of 1–5 mg/incremental dose, recommended lockout interval is 6–10 min (minimum 5 min).
• IV (Children): Continuous infusion: 0.5–1 mg/kg loading dose followed by 0.3 mg/kg/hr, titrate to effect up to 0.5–0.7 mg/kg/hr.

Demerol

• Binds to opiate receptors in the CNS. Alters the perception of and response to painful stimuli while producing generalized CNS depression.

• Reduction in severity of pain.

Therapeutic Classification: opioid analgesics

Pharmacologic Classification: opioid agonists

Absorption: 50% from the GI tract; well absorbed from IM sites. Oral doses are about half as effective as parenteral doses. IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Mostly metabolized by the liver; some converted to normeperidine, which may accumulate and cause seizures. 5% excreted unchanged by the kidneys.

Half-life: Neonates: 12–39 hr; Infants 3–18 mo: 2.3 hr; Children 5–8 yr: 3 hr; Adults: 2.5–4 hr (↑ in impaired renal or hepatic function [7–11 hr]).

Schedule II (C-II)

(analgesia)

• Explain purpose and side effects of meperidine to patient. Advise patient to not share medication with others, even if they have similar symptoms; may be harmful. Advise patient to read Patient Informationbefore starting and with each Rx refill in case of changes.
• REMS: Instruct patient to take meperidine as directed. If dose is less effective after a few wk, do not ↑ dose without consulting health care professional. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at OpioidAnalgesicREMSPCG. Pedi: Teach parents or caregivers how to accurately measure liquid medication and to use only the measuring device dispensed with the medication.
• Advise patient that meperidine is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children and in a location not accessible by others.
• May cause drowsiness or dizziness. Advise patient to call for assistance when ambulating and to avoid driving or other activities that require alertness until response to the medication is known.
• Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about various ways to obtain naloxone as permitted by individual state naloxone-dispensing and prescribing requirements or guidelines (Rx, direct from pharmacist, or state programs). OTC naloxone nasal spray is available at pharmacies nationwide for overdose or accidental ingestion.
• Advise patient to change positions slowly to minimize orthostatic hypotension.
• Instruct patient to avoid concurrent use of alcohol or other CNS depressants, may lead to overdose.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise ambulatory patients that nausea and vomiting may be ↓ by lying down.
• Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
• Rep: May cause fetal harm. Advise females with reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, failure to gain weight); usually occur the first days after birth. Monitor infants exposed to meperidine through breast milk for excess sedation and respiratory depression. Chronic use may ↓ fertility in females and males.

me-PER-i-deen

NDC Code^*

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-3545- Meperidine Hydrochloride
    • 0054-3545-63- 500 mL in 1 BOTTLE (0054-3545-63)

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-4595- Meperidine Hydrochloride
    • 0054-4595-25- 100 TABLET in 1 BOTTLE (0054-4595-25)

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-4596- Meperidine Hydrochloride
    • 0054-4596-25- 100 TABLET in 1 BOTTLE (0054-4596-25)

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-8595- Meperidine Hydrochloride
    • 0054-8595-11- 1 BLISTER PACK in 1 BOX (0054-8595-11) > 25 TABLET in 1 BLISTER PACK

• 0409- Hospira, Inc.
  • 0409-1176- DEMEROL
    • 0409-1176-30- 10 CARTRIDGE in 1 CARTON (0409-1176-30) > 1 mL in 1 CARTRIDGE (0409-1176-03)

• 0409- Hospira, Inc.
  • 0409-1178- DEMEROL
    • 0409-1178-30- 10 CARTRIDGE in 1 CARTON (0409-1178-30) > 1 mL in 1 CARTRIDGE (0409-1178-03)

• 0409- Hospira, Inc.
  • 0409-1179- DEMEROL
    • 0409-1179-30- 10 CARTRIDGE in 1 CARTON (0409-1179-30) > 1 mL in 1 CARTRIDGE (0409-1179-03)

• 0409- Hospira, Inc.
  • 0409-1180- DEMEROL
    • 0409-1180-69- 10 CARTRIDGE in 1 CARTON (0409-1180-69) > 1 mL in 1 CARTRIDGE (0409-1180-59)

• 0409- Hospira, Inc.
  • 0409-1181- DEMEROL
    • 0409-1181-30- 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1181-30) > 30 mL in 1 VIAL, MULTI-DOSE

• 0409- Hospira, Inc.
  • 0409-1201- DEMEROL
    • 0409-1201-20- 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1201-20) > 20 mL in 1 VIAL, MULTI-DOSE

• 0409- Hospira, Inc.
  • 0409-1203- DEMEROL
    • 0409-1203-01- 25 AMPULE in 1 CARTON (0409-1203-01) >.5 mL in 1 AMPULE (0409-1203-11)

• 0409- Hospira, Inc.
  • 0409-1253- DEMEROL
    • 0409-1253-01- 25 AMPULE in 1 CARTON (0409-1253-01) > 1 mL in 1 AMPULE (0409-1253-11)

• 0409- Hospira, Inc.
  • 0409-1254- DEMEROL
    • 0409-1254-01- 25 AMPULE in 1 CARTON (0409-1254-01) > 1.5 mL in 1 AMPULE (0409-1254-11)

• 0409- Hospira, Inc.
  • 0409-1255- DEMEROL
    • 0409-1255-02- 25 AMPULE in 1 CARTON (0409-1255-02) > 2 mL in 1 AMPULE (0409-1255-12)

• 0409- Hospira, Inc.
  • 0409-1256- DEMEROL
    • 0409-1256-01- 25 AMPULE in 1 CARTON (0409-1256-01) > 1 mL in 1 AMPULE (0409-1256-11)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0381- Meperidine Hydrochloride
    • 0555-0381-02- 100 TABLET in 1 BOTTLE (0555-0381-02)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0392- Meperidine Hydrochloride
    • 0555-0392-02- 100 TABLET in 1 BOTTLE (0555-0392-02)

• 0641- West-Ward Pharmaceuticals Corp.
  • 0641-6052- MEPERIDINE HYDROCHLORIDE
    • 0641-6052-25- 25 VIAL in 1 CARTON (0641-6052-25) > 1 mL in 1 VIAL (0641-6052-01)

• 0641- West-Ward Pharmaceuticals Corp.
  • 0641-6053- MEPERIDINE HYDROCHLORIDE
    • 0641-6053-25- 25 VIAL in 1 CARTON (0641-6053-25) > 1 mL in 1 VIAL (0641-6053-01)

• 0641- West-Ward Pharmaceuticals Corp.
  • 0641-6054- MEPERIDINE HYDROCHLORIDE
    • 0641-6054-25- 25 VIAL in 1 CARTON (0641-6054-25) > 1 mL in 1 VIAL (0641-6054-01)

• 30698- Validus Pharmaceuticals LLC
  • 30698-335- Demerol
    • 30698-335-01- 100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)

• 30698- Validus Pharmaceuticals LLC
  • 30698-337- Demerol
    • 30698-337-01- 100 TABLET in 1 BOTTLE, PLASTIC (30698-337-01)

• 42806- EPIC PHARMA, LLC
  • 42806-050- Meperidine Hydrochloride
    • 42806-050-01- 100 TABLET in 1 BOTTLE (42806-050-01)

• 42806- EPIC PHARMA, LLC
  • 42806-051- Meperidine Hydrochloride
    • 42806-051-01- 100 TABLET in 1 BOTTLE (42806-051-01)

• 46672- Mikart, LLC
  • 46672-829- meperidine hydrochloride
    • 46672-829-10- 100 TABLET in 1 BOTTLE, PLASTIC (46672-829-10)

• 46672- Mikart, LLC
  • 46672-829- meperidine hydrochloride
    • 46672-829-50- 500 TABLET in 1 BOTTLE, PLASTIC (46672-829-50)

• 46672- Mikart, LLC
  • 46672-830- meperidine hydrochloride
    • 46672-830-10- 100 TABLET in 1 BOTTLE, PLASTIC (46672-830-10)

• 46672- Mikart, LLC
  • 46672-831- meperidine hydrochloride
    • 46672-831-10- 100 TABLET in 1 BOTTLE, PLASTIC (46672-831-10)

• 46672- Mikart, LLC
  • 46672-831- meperidine hydrochloride
    • 46672-831-50- 500 TABLET in 1 BOTTLE, PLASTIC (46672-831-50)

• 46672- Mikart, LLC
  • 46672-832- meperidine hydrochloride
    • 46672-832-10- 100 TABLET in 1 BOTTLE, PLASTIC (46672-832-10)