Meperidine Hydrochloride 50 mg/5mL Solution, 500 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Meperidine is used to relieve severe pain. Meperidine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Read the full MedlinePlus article ↗- Meperidine is a strong opioid used for severe pain when other options haven't worked well enough or can't be used. It's also commonly given before surgery to help you relax or duri...
- Why was I given meperidine instead of another pain medication?
- No — please avoid alcohol entirely. Combining alcohol with meperidine can dangerously slow your breathing, cause extreme sedation, and in serious cases lead to coma or death. This...
- Is it safe to drink alcohol while receiving meperidine?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 3A9RD92BS4
Maltol is a naturally occurring organic compound found in foods like bread crust and coffee. In medicines, it acts as a flavoring agent to mask bitter tastes and improve palatability.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.156 | $77.90 / 500 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.30 | $651.55 / 500 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.2121 | $106.05 / 500 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Meperidine Hydrochloride 50 mg/5mLthis 00054-3545-63 | Hikma | 500 ml | $0.156 | — | Availability likely | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00054-3545-63 You're viewing this | 500 mL in 1 BOTTLE (0054-3545-63) | 1985-01-30 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] . Addiction, Abuse, and Misuse Because the use of Meperidine Hydrochloride Tablets and Oral Solution 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 [see Warnings and Precautions ( 5.2 )] .
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Meperidine Hydrochloride Tablets and Oral Solution, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Meperidine Hydrochloride Tablets or Oral Solution are essential [see Warnings and Precautions ( 5.3 )]. Accidental Ingestion Accidental ingestion of Meperidine Hydrochloride Tablets and Oral Solution, especially by children, can result in a fatal overdose of meperidine [see Warnings and Precautions ( 5.3 )] .
Risks From Concomitant Use with Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Meperidine Hydrochloride Tablets and Oral Solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )] .
Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.5 )] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions ( 5.6 )].
Cytochrome P450 3A4 (CYP3A4) Interaction The concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with all cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 (CYP3A4) inducer may result in an increase in meperidine plasma concentration. Monitor patients receiving Meperidine Hydrochloride Tablets or Oral Solution, and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.7 ), Drug Interactions (7 )].
Concomitant use of Meperidine Hydrochloride Tablets and Oral Solution with Monoamine Oxidase Inhibitors (MAOIs) Concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with monoamine oxidase inhibitors (MAOIs) can result in coma, severe respiratory depression, cyanosis, and hypotension. Use of Meperidine Hydrochloride Tablets or Oral Solution with MAOIs within last 14 days is contraindicated [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 ), Drug Interactions ( 7 )]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION See full pr…
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute 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 Meperidine Hydrochloride Tablets or Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine. Meperidine Hydrochloride Tablets and Oral Solution are opioid agonists indicated for the management of pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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 Meperidine Hydrochloride Tablets and Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
( 1 , 5.2 ) Use of Meperidine Hydrochloride Tablets and Oral Solution for an extended period of time may increase the risk of toxicity (e.g ., seizures) from the accumulation of the meperidine metabolite, normeperidine.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Meperidine Hydrochloride Tablets and Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Meperidine Hydrochloride Tablets and Oral Solution 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.
( 2.1 , 5 ) • 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. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
( 2.1 , 5.2 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Meperidine Hydrochloride Tablets and Oral Solution. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.3 ) • Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Meperidine Hydrochloride Tablets and Oral Solution, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.
( 2.2 , 5.2 , 5.3 , 5.4 ) • Adult Patients : Initiate treatment in adults with 50 mg to 150 mg orally, every 3 to 4 hours as needed for pain, and at lowest dose necessary to achieve adequate analgesia ( 2.3 ). Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. • Pediatric Patients : Initiate treatment in pediatric patients with 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as needed and at the lowest dose necessary to achieve adequate analgesia ( 2.3 ).
Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. • Periodically reassess patients receiving Meperidine Hydrochloride Tablets and Oral Solution to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.5 ) • Do not rapidly reduce or abruptly discontinue Meperidine Hydrochloride Tablets and Oral Solution in a physically-dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
( 2.5 , 5.17 )
2.1Important Dosage and Administration Instructions Meperidine Hydrochloride Oral Solution Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other meperidine solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Meperidine Hydrochloride Oral Solution. Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy a…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Meperidine Hydrochloride Tablets, USP: • 50 mg tablet is supplied as a white, round tablet, scored on one side with “54 879” debossed on the other side. • 100 mg tablet is supplied as a white, round tablet, scored on one side with “54 163” debossed on the other side. Meperidine Hydrochloride Oral Solution, USP: • 50 mg/5 mL oral solution: clear, colorless, slightly viscous solution. Tablets: 50 mg and 100 mg.
( 3 ) Oral Solution: 50 mg/5 mL (10 mg/mL)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Meperidine Hydrochloride Tablets and Oral Solution are contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions ( 5.3 )] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.11 )] • Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of having taken an MAOI [see Drug Interactions ( 7 )] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.15 )] • Hypersensitivity to meperidine or to any of the other ingredients of the product (e.g., anaphylaxis) [see Adverse Reactions ( 6 )] • Significant respiratory depression.
( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of having taken an MAOI. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus.
( 4 ) • Hypersensitivity to meperidine or to any other ingredients of the product. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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. ( 5.9 ) • Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration.
Discontinue Meperidine Hydrochloride Tablets or Oral Solution if serotonin syndrome is suspected. ( 5.10 ) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate closely, particularly during initiation and titration. ( 5.11 ) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
( 5.12 ) • Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use of Meperidine Hydrochloride Tablets or Oral Solution in patients with circulatory shock. ( 5.13 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Regularly evaluate for sedation and respiratory depression.
Avoid use of Meperidine Hydrochloride Tablets or Oral Solution in patients with impaired consciousness or coma. ( 5.14 )
5.1Risks of Accidental Overdose and Death Due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with meperidine solutions of different concentrations, when prescribing, dispensing, and administering Meperidine Oral Solution. Ensure that the dose is communicated clearly and dispensed accurately.
Instruct patients and caregivers on how to measure and take or administer the correct dose of Meperidine Oral Solution and to use extreme caution when measuring the dose. Strongly advise patients to obtain and always use a graduated device that can measure and deliver the prescribed dose accurately, and to never use household teaspoons or tablespoons to measure a dose because these are not accurate measuring devices [see Dosage and Administration ( 2.1 )].
5.2Addiction, Abuse, and Misuse Meperidine Hydrochloride Tablets and Oral Solution contain meperidine, a Schedule II controlled substance. As an opioid, Meperidine Hydrochloride Tablets and Oral Solution expose users to the risks of addiction, abuse and misuse [see Drug Abuse and Dependence ( 9 )] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Meperidine Hydrochloride Tablets or Oral Solution.
Addiction can occur at recommended doses and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and the risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions ( 6 )].
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Meperidine Hydrochloride Tablets and Oral Solution, and reassess all patients receiving Meperidine Hydrochloride Tablets or Oral Solution for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as Meperidine Hydrochloride Tablets or Oral Solution, but use in such patients necessitates intensive counseling about the risks and proper use of Meperidine Hydrochloride Tablets and Oral Solution alon…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.2 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.4 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.9 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.10 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.12 )] • Severe Hypotension [see Warnings and Precautions ( 5.13 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.15 )] • Seizures [see Warnings and Precautions ( 5.16 )] • Withdrawal [see Warnings and Precautions ( 5.17 )] 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. The major hazards of meperidine, as with other opioid analgesics, are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most frequently observed adverse reactions included lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.
These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.
Other adverse reactions include: Nervous System: Mood changes (e.g., euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g., muscle twitches, myoclonus), severe convulsions, seizures, transient hallucinations and disorientation, confusion, delirium, visual disturbances. Gastrointestinal: Dry mouth, constipation, biliary tract spasm. Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension [see Warnings and Precautions ( 5.7 )], syncope.
Genitourinary: Urinary retention. Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection. Hypersensitivity reactions, anaphylaxis.
Histamine release leading to hypotension and/or tachycardia, flushing, sweating, and pruritus. Serotonin Syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Androgen Deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see Clinical Pharmacology ( 12.2 )]. Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions ( 5.9 )]. Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids.
Most reports were in patients with at least one predisposing risk factor (e.g., diabetes). Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term [see Warnings and Precautions ( 5.15 )]. Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021.
Study participants included in one or more analyses had been enrolled in selected insurance plans…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Meperidine Hydrochloride Tablets and Oral Solution. Table 1: Clinically Significant Drug Interactions with Meperidine Hydrochloride Tablets and Oral Solution Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Meperidine is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) 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. Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur.
In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Intervention: Do not use Meperidine Hydrochloride Tablets or Oral Solution in patients taking MAOIs or within 14 days of stopping such treatment. Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia.
The usefulness and safety of opioid overdose reversal agents in the treatment of these reactions is unknown. Examples: phenelzine, tranylcypromine, linezolid Inhibitors of CYP3A4 and CYP2B6 Clinical Impact: The concomitant use of Meperidine Hydrochloride Tablets or Oral Solution and CYP3A4 or CYP2B6 inhibitors can increase the plasma concentration of meperidine, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Meperidine Hydrochloride Tablets or Oral Solution and CYP2B6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Meperidine Hydrochloride Tablets or Oral Solution is achieved [see Warnings and Precautions ( 5.7 )].
After stopping a CYP3A4 or CYP2B6 inhibitor, as the effects of the inhibitor decline, the meperidine plasma concentration will decrease [see Clinical Pharmacology ( 12.3 )], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to meperidine. Intervention: If concomitant use is necessary, consider dosage reduction of Meperidine Hydrochloride Tablets or Oral Solution until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation.
If a CYP3A4 or CYP2B6 inhibitor is discontinued, consider increasing the meperidine dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 and CYP2B6 Inducers Clinical Impact: The concomitant use of meperidine and CYP3A4 or CYP2B6 inducers can decrease the plasma concentration of meperidine [see Clinical Pharmacology ( 12.3 )], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to meperidine [see Warnings and Precautions ( 5.7 )].
After stopping a CYP3A4 or CYP2B6 inducer, as the effects of the inducer decline, the meperidine plasma concentration will increase [see Clinical Pharmacology ( 12.3 )], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the Meperidine Hydrochloride Tablets or Oral Solution dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal.
If a CYP3A4 or CYP2B6 inducer is discontinued, consider…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.5 )]. Available data with meperidine is insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. 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 1,200 mg [see Data]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.5 )]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
Resuscitation may be required [see Overdose ( 10 )]. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Meperidine is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate.
Opioid analgesics, including Meperidine Hydrochloride Tablets and Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Data Animal Data Formal reproductive and developmental toxicology studies for meperidine have not been completed. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of meperidine hydrochloride (127 and 218 mg/kg, respectively) on Gestation Day 8 to pregnant hamsters (0.85 and 1.5 times the total daily dose of 1,200 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity.
8.2Lactation Risk Summary Meperidine appears in the milk of nursing mothers receiving the drug. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meperidine and any potential adverse effects on the breastfed infant from Meperidine Hydrochloride Tablets or Oral Solution or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to Meperidine Hydrochloride Tablets or Oral Solution through breast milk for excess sedation and respiratory depression.
Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when b…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.5 )]. Available data with meperidine is insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. 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 1,200 mg [see Data]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.5 )]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
Resuscitation may be required [see Overdose ( 10 )]. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Meperidine is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate.
Opioid analgesics, including Meperidine Hydrochloride Tablets and Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Data Animal Data Formal reproductive and developmental toxicology studies for meperidine have not been completed. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of meperidine hydrochloride (127 and 218 mg/kg, respectively) on Gestation Day 8 to pregnant hamsters (0.85 and 1.5 times the total daily dose of 1,200 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of meperidine in pediatric patients has not been established. Literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects.
If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of meperidine during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. Reducing the total daily dose of meperidine is recommended in elderly patients, and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient.
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Meperidine Hydrochloride Tablets or Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions ( 5.11 )]. Meperidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation: Acute overdose with meperidine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology ( 12.2 )] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.
Accumulation of normeperidine as in chronic use or possibly following introduction of a concomitant CYP3A4 inducer presents as excitatory syndrome including hallucinations, tremors, muscle twitches, dilated pupils, hyperactive reflexes, and convulsions. Treatment of Overdose: In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of meperidine in Meperidine Hydrochloride Tablets and Oral Solution, carefully monitor the patient until spontaneous respiration is reliably reestablished.
If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of reversal agent administered.
If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Meperidine 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.
12.2Pharmacodynamics Effects on the Central Nervous System Meperidine produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Meperidine causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Meperidine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED).
Effects on the Cardiovascular System Meperidine produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions ( 6 )].
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions ( 6 )].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with opioid agonists. The minimum effective analgesic concentration of meperidine for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see Dosage and Administration ( 2.1 )]. Concentration–Adverse Reaction Relationships There is a relationship between increasing meperidine plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.
In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration ( 2.1 )].
12.3Pharmacokinetics Absorption Oral bioavailability of meperidine is approximately 50%. Elimination The elimination half-life is 3 to 8 hours in he…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Meperidine 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Meperidine Hydrochloride Tablets, USP 50 mg tablet is supplied as a white, round tablet, scored on one side with “54 879” debossed on the other side. NDC 0054-8595-11: 1 x 25 Unit-Dose (Reverse Numbered) Tablets NDC 0054-4595-25: Bottle of 100 Tablets 100 mg tablet is supplied as a white, round tablet, scored on one side with “54 163” debossed on the other side. NDC 0054-4596-25: Bottle of 100 Tablets Meperidine Hydrochloride Oral Solution, USP 50 mg per 5 mL oral solution is supplied as a clear, colorless, slightly viscous (unflavored) solution.
NDC 0054-3545-63: Bottle of 500 mL Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store Meperidine Hydrochloride Tablets and Oral Solution securely and dispose of properly.
📋 Description ▾
11 DESCRIPTION Meperidine hydrochloride is an opioid agonist, available as 50 mg and 100 mg tablets or 50 mg per 5 mL solution for oral administration. The chemical name is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79.
Its molecular formula is C 15 H 21 NO 2 • HCl, and it has the following chemical structure. Meperidine hydrochloride, USP is a fine, white, crystalline powder with a melting point of 186°C to 189°C. It is very soluble in water and has a neutral reaction.
The solution is not decomposed by a short period of boiling. Each Meperidine Hydrochloride Tablet, USP for oral administration contains either 50 mg or 100 mg meperidine hydrochloride, USP and the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Each 5 mL of Meperidine Hydrochloride Oral Solution, USP for oral administration contains 50 mg meperidine hydrochloride, USP and the following inactive ingredients: glycerin, hydrochloric acid, maltol, sodium benzoate, sorbitol solution and purified water. chem-meperidine.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Meperidine Hydrochloride Tablets and Oral Solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home . Inform patients that leaving Meperidine Hydrochloride Tablets and Oral Solution unsecured can pose a deadly risk to others in the home [see Warnings and Precautions ( 5.1 , 5.2 ), Drug Abuse and Dependence ( 9 )] .
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Meperidine Hydrochloride Tablets and Oral Solution should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Medication Errors Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure Meperidine Hydrochloride Oral Solution [see Warnings and Precautions ( 5.1 )] . If the prescribed dosage is changed, instruct patients and caregivers on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
Addiction, Abuse, and Misuse Inform patients that the use of Meperidine Hydrochloride Tablets or Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions ( 5.2 )]. Instruct patients not to share Meperidine Hydrochloride Tablets or Oral Solution with others and to take steps to protect Meperidine Hydrochloride Tablets or Oral Solution from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Meperidine Hydrochloride Tablets or Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages.
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 [see Warnings and Precautions ( 5.3 )]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions ( 5.3 )]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Meperidine Hydrochloride Tablets or Oral Solution are used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )].
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid over…
💬 Medication Guide ▾
Medication Guide Meperidine Hydrochloride Tablets and Oral Solution, USP, CII (me per’ i deen hye” droe klor’ ide) Rx only Meperidine Hydrochloride Tablets and Oral Solution are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage the relief short-term (acute) pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about Meperidine Hydrochloride Tablets and Oral Solution: • Get emergency help or call 911 right away if you take too much Meperidine Hydrochloride Tablets or Oral Solution (overdose). When you first start taking Meperidine Hydrochloride Tablets or Oral Solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdo se. • Taking Meperidine Hydrochloride Tablets and Oral Solution with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your Meperidine Hydrochloride Tablets and Oral Solution.
They could die from taking it. Selling or giving away Meperidine Hydrochloride Tablets and Oral Solution is against the law. • Store Meperidine Hydrochloride Tablets and Oral Solution away from children and in a safe location not accessible by others, including visitors to the home. Do not take Meperidine Hydrochloride Tablets and Oral Solution if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • allergy to meperidine.
Before taking Meperidine Hydrochloride Tablets and Oral Solution, tell your healthcare provider if you have a history of: • head injury, seizures • problems urinating • liver, kidney, thyroid problems • pancreas or gallbladder problems • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems. Tell your healthcare provider if you are: • noticing your pain getting worse. If your pain gets worse after you take Meperidine Hydrochloride Tablets or Oral Solution, do not take more of Meperidine Hydrochloride Tablets or Oral Solution without first talking to your healthcare provider.
Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking Meperidine Hydrochloride Tablets or Oral Solution. • pregnant or planning to become pregnant . Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • breastfeeding . Meperidine hydrochloride passes into breast milk and may harm your baby.
Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs. • living in a household where there are small children or someone who has abused street or prescription drugs. • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Meperidine Hydrochloride Tablets and Oral Solution with certain other medicines can cause serious side effects that could lead to death.
When taking Meperidine Hydrochloride Tablets or Oral Solution: • Do not change your dose. Take Meperidine Hydrochloride Tablets and Oral Solution exactly as prescribed by your healthcare provider. Use the lowe…