Meperidine is an active pharmaceutical ingredient in the Phenylpiperidine Derivatives group (N02AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised January 7, 2016[1]
Pethidine hydrochloride may be used in the management of severe pain, including pain associated with surgical procedures, as a pre-anaesthetic medication and in obstetric analgesia.
How to take
GB
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised February 27, 2026[2]
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.
, 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.
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS .........................................................................................
4 ADVERSE REACTIONS......................................................................................................... 12 DRUG INTERACTIONS .........................................................................................................
14 DOSAGE AND ADMINISTRATION ..................................................................................... 15 OVERDOSAGE .......................................................................................................................
19 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 20 STORAGE AND STABILITY ................................................................................................. 22 SPECIAL HANDLING INSTRUCTIONS ..............................................................................
Drug interactions
Known interactions involving Meperidine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 513. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL298310174 · revised January 7, 2016
[2]FDA DailyMed · 15bc51a8-1e24-4d… · revised February 27, 2026 [PDF]
[3]Health Canada (DPD) · 00725765 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Pethidine may be given by intramuscular, subcutaneous or slow intravenous injection. For intravenous administration the contents of the ampoule can be diluted to 10ml with Water for Injections giving a strength of 5 mg/ml(1 ml ampoule) or 10 mg/ml (2ml ampoule).
Pre-anaesthetic medication Administered about one hour before the operation. Adults : 50mg-100mg by intramuscular injection. Elderly: 50mg-100mg by intramuscular injection. Elderly patients may be more sensitive to pethidine. 0mg/kg by intramuscular injection Obstetric analgesia 50-100mg may be given by intramuscular or subcutaneous injection as soon as contractions occur at regular intervals.
The dose may be repeated after one to three hours if necessary up to a maximum of 400mg in 24 hours. Management of severe pain, including post-operative pain Adults : 25 mg-100mg by intramuscular or subcutaneous injection every four hours By slow intravenous injection 25-50mg repeated every four hours.
Elderly: 25 mg-100mg by intramuscular or subcutaneous injection every four hours. By slow intravenous injection 25-50mg repeated every four hours. Elderly patients may be more sensitive to pethidine. The total daily dose may need to be reduced in elderly patients receiving repeated doses.
Initial doses should not exceed 25mg as this group of patients may be especially sensitive to the central depressant effect of the drug. 5 - 2mg/kg by intramuscular injection every four hours. Hepatic impairment The dose should be reduced.
Renal impairment The dose should be reduced in mild to moderate impairment. Severe renal impairment is a contraindication to use (see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 7, 2016[1]
The most serious hazard of therapy is respiratory depression (see also
GBOfficial regulatory label· Warnings and precautions· revised January 7, 2016[1]
3 Contraindications • Known hypersensitivity to pethidine. • Severe renal impairment. • Acute respiratory depression. • Concurrent use of monoamine oxidase inhibitors (including moclobemide and phenelzine) or use within two weeks of their discontinuation, as severe CNS excitation or depression (hypertension or hypotension) may occur.
• Concurrent use of ritonavir – risk of norpethidine toxicity. • Concurrent use of selegiline – risk of hyperpyrexia and CNS toxicity. • Phaeochromocytoma • Coma • Raised intracranial pressure or head injury, as there is an increased risk of respiratory depression that may lead to elevation of CSF pressure.
The sedation and pupillary changes produced may interfere with accurate monitoring of the patient. • Acute alcoholism. • Where there is a risk of paralytic ileus or in acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis or diarrhoea caused by poisoning (until the toxic material has been eliminated).
4 Special warnings and precautions for use Repeated administration of pethidine may lead to dependence and tolerance developing, but this should not deter its use in the control of pain in terminal illness. Abrupt withdrawal in patients who have developed tolerance may precipitate a withdrawal syndrome.
Caution should be exercised in patients with a known tendency or history of drug abuse. Babies born to opioid dependent mothers may suffer withdrawal symptoms. 3 Contraindications). Use with caution or in reduced doses in patients with biliary tract disorders, hypothyroidism, adreno-cortical insufficiency, hypotension, shock, prostatic hypertrophy, urethral stricture, inflammatory or obstructive bowel disorders, myasthenia gravis, supraventricular tachycardia, a history of convulsive disorders, and in debilitated patients.
Pethidine neurotoxicity may be seen in patients with renal failure, cancer or sickle cell anaemia, during concomitant administration of drugs that may increase the production of the metabolite norpethidine (see
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 7, 2016[1]
). For concomitant illnesses/conditions where dose reduction may be appropriate see
This is not medical advice. Consult a qualified healthcare professional.
, seizures) from the accumulation of the meperidine metabolite, normeperidine.
How to take
USOfficial regulatory label· revised February 27, 2026[2]
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. 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.
, 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.
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 ) • 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. 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.
3 ). Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. 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.
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.
1 Important 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.
, 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.
Meperidine Hydrochloride Tablets and Oral Solution 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.
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )]. Because the risk of overdose increases as opioid doses increase, 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.
, 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.
There is variability in the opioid analgesic dose and duration needed to adequately manage pain due to both to the cause of pain and to individual patient factors. 1 )]. 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 [see Warnings and Precautions ( 5 )]. 2. , naloxone, nalmefene). , concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
4 )]. 3 )]. There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.
3 Initial Dosage Adults Initiate treatment with Meperidine Hydrochloride Tablets or Oral Solution in a dosing range of 50 mg to 150 mg orally, every 3 or 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.
Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. 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.
Titrate the dose based upon the individual patient’s response to their initial dose of Meperidine Hydrochloride Tablets and Oral Solution. 4 Dosage Modification with Concomitant Use with Phenothiazines The dose of Meperidine Hydrochloride Tablets or Oral Solution should be reduced by 25 to 50% when administered concomitantly with phenothiazines and other tranquilizers.
5 Titration and Maintenance of Therapy Individually titrate Meperidine Hydrochloride Tablets and Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. If adequate pain management cannot be achieved with a total daily dosage of 600 mg or less, discontinue treatment with Meperidine Hydrochloride Tablets or Oral Solution by tapering the dose and select an alternate analgesic.
2 )] . Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Meperidine Hydrochloride Tablets or Oral Solution dosage.
If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions ( 5 )]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
6 Safe Reduction or Discontinuation of Meperidine Hydrochloride Tablets and Oral Solution Do not rapidly reduce or abruptly discontinue Meperidine Hydrochloride Tablets and Oral Solution in patients who may be physically dependent on opioids.
Rapid reduction or abrupt discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid reduction or abrupt discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking Meperidine Hydrochloride Tablets and Oral Solution, there are a variety of factors that should be considered, including the total daily dose of opioid (including Meperidine Hydrochloride Tablets and Oral Solution) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.
Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients.
Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. , no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.
Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.
Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time, and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
3 )].
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised February 27, 2026[2]
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.
, muscle twitches, myoclonus), severe convulsions, seizures, transient hallucinations and disorientation, confusion, delirium, visual disturbances.
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. 2 )]. 9 )].
Hypoglycemia:
Cases of hypoglycemia have been reported in patients taking opioids. , diabetes). 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 or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244).
Those included also had no dispensing of the qualifying opioids in the previous 6 months. 2 )], respectively, as measured with a validated self-reported instrument. A retrospective, observational cohort study estimated the risk of opioid-involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220, 249).
Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months. New long-term use was defined as having Schedule II opioid analgesic prescriptions covering at least 70 days’ supply over the 3 months prior to study entry and none during the preceding 6 months.
Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study entry. Overdose was measured using a validated medical code-based algorithm with linkage to the National Death Index database. 5% to 4% across study sites, counting only the first event during follow-up.
Approximately 17% of first opioid overdoses observed over the entire study period (5-11 years, depending on the study site) were fatal. Higher baseline opioid dose was the strongest and most consistent predictor of opioid-involved overdose or opioid overdose-related death.
Study exclusion criteria may have selected patients at lower risk of overdose, and substantial loss to follow-up (approximately 80%) also may have biased estimates. The risk estimates from the studies described above may not be generalizable to all patients receiving opioid analgesics, such as those with exposures shorter or longer than the duration evaluated in the studies.
Most common adverse reactions were lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised February 27, 2026[2]
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.
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. 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.
11 ) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. 12 ) • Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use of Meperidine Hydrochloride Tablets or Oral Solution in patients with circulatory shock.
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.
1 Risks 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.
1 )]. 2 Addiction, 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 )] .
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised February 27, 2026[2]
, 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 )
This is not medical advice. Consult a qualified healthcare professional.
22 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 23 PART II: SCIENTIFIC INFORMATION ............................................................................... 24 PHARMACEUTICAL INFORMATION.................................................................................
Error! Bookmark not defined. Meperidine Hydrochloride Injection USP Page 3 of 33 MEPERIDINE HYDROCHLORIDE INJECTION USP meperidine hydrochloride PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of administration Dosage Form / Strength Nonmedicinal Ingredients Subcutaneous, intramuscular or intravenous (after dilution) 50 mg/mL Sodium hydroxide and/or hydrochloric acid, water.
INDICATIONS AND CLINICAL USE Meperidine Hydrochloride Injection USP is indicated for the relief of acute episodes of moderate to severe pain in many medical, surgical, obstetrical and dental situations (see DOSAGE AND ADMINISTRATION).
Meperidine Hydrochloride Injection USP is not indicated as an as-needed (prn) analgesic. Geriatrics (> 65 years of age) In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
Pediatrics (< 18 years of age) The safety and efficacy of Meperidine Hydrochloride Injection USP has not been studied in the pediatric population. Therefore the use of Meperidine Hydrochloride Injection USP is not recommended in patients under 18 years of age.
CONTRAINDICATIONS Meperidine is contraindicated in: • Patients who are hypersensitive to the active substance meperidine or other opioid analgesics or to any ingredient in the formulation. For a complete listing of the excipients, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section.
, ileus of any type). , acute appendicitis or pancreatitis). • Patients with mild pain that can be managed with other pain medications. Meperidine Hydrochloride Injection USP Page 4 of 33 • Patients with acute or severe bronchial asthma, chronic obstructive airway, and or status asthmaticus.
• Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale. • Patients with acute alcoholism, delirium tremens, and convulsive disorders. • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
• Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). , non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION).
As with other CNS depressants, patients who have received Meperidine Hydrochloride Injection USP should have appropriate surveillance. Resuscitative equipment and a narcotic antagonist such as naloxone should be readily available to manage apnea.
Addiction, Abuse, and Misuse Meperidine Hydrochloride Injection USP poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient’s risk should be assessed prior to prescribing Meperidine Hydrochloride Injection USP, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS).
Meperidine Hydrochloride Injection USP should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of Meperidine Hydrochloride Injection USP. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of Meperidine Hydrochloride Injection USP or following a dose increase. Further, instruct patients of the hazards related to taking opioids including fatal overdose.
CAOfficial regulatory label· revised March 22, 2025[3]
). Sexual Function/Reproduction Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as low libido, erectile dysfunction, or infertility (see ADVERSE REACTIONS, Post- Market Adverse Drug Reactions).
Special Populations Special Risk Groups:
Meperidine should be given with caution and the initial dose should be reduced in certain patients such as the elderly or debilitated, and those with hypothyroidism, Addison's disease and prostatic hypertrophy or urethral stricture (due to the risk of urinary retention), sickle cell anemia, delirium tremens, kyphoscoliosis associated with respiratory depression, pheochromocitoma.
In patient with pheochromocitoma, meperidine has been reported to provoke hypertension. Meperidine should also be used with cautions in patients with decreased level of consciousness. The administration of meperidine may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
All opioids may induce or aggravate seizures in some clinical settings.
Pregnant Women:
Studies in humans have not been conducted. Meperidine Hydrochloride Injection USP crosses the placental barrier and is not recommended to be administered to pregnant women unless, in the judgement of the physician, potential benefits outweigh the risks.
Pregnant women using opioids should not discontinue their medication abruptly as this can cause pregnancy complication such as miscarriage or still-birth. Tapering should be slow and under medical supervision to avoid serious adverse events to the fetus.
Prolonged maternal use of opioids during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening (see WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome, ADVERSE REACTIONS, Post-marketing Experience).
Meperidine Hydrochloride Injection USP Page 12 of 33 Labour, Delivery and Nursing Women: Since opioids can cross the placental barrier and are excreted in breast milk, Meperidine Hydrochloride Injection USP is not recommended to be used in nursing women and during labour and delivery unless, in the judgement of the physician, the potential benefits outweigh the risks.
Life-threatening respiratory depression can occur in the infant if opioids are administered to the mother. Naloxone, a drug that counters the effects of opioids, should be readily available if Meperidine Hydrochloride Injection USP is used in this population.
Pediatrics (< 18 years of age):
The safety and efficacy of Meperidine Hydrochloride Injection USP have not been studied in the pediatric population. Therefore, use of Meperidine Hydrochloride Injection USP is not recommended in patients under 18 years of age.
Geriatrics (> 65 years of age):
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range and titrate slowly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
Patients with Hepatic Impairment:
Meperidine Hydrochloride Injection USP should be administered with caution and reduced initial doses to patients with liver dysfunction.
Patients with Renal Impairment:
Meperidine Hydrochloride Injection USP should be administered with caution and reduced initial doses to patients with kidney dysfunction. ADVERSE REACTIONS Adverse Drug Reaction Overview Adverse effects of Meperidine Hydrochloride Injection USP are similar to those of other opioid analgesics, and represent an extension of pharmacological effects of the drug class.
The major hazards of opioids include respiratory and central nervous system depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. Most Frequently Observed The most frequently observed adverse reactions include 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.
Less Frequently Observed Central Nervous System Mood changes (such as euphoria, dysphoria), weakness, headache, agitation, tremor, muscle twitches, severe convulsions, uncoordinated muscle movements, transient hallucinations and disorientation, delirium or confusion, visual disturbances.
Meperidine Hydrochloride Injection USP Page 13 of 33 Inadvertent injection into or near a nerve trunk may result in sensory-motor paralysis which is usually, though not always, transitory. Gastrointestinal Dry mouth, constipation, biliary tract spasm.
Cardiovascular Flushing of the face, tachycardia, bradycardia, palpitation, hypotension (see WARNINGS), syncope and phlebitis following IV injection. Genitourinary Urinary retention. Dermatologic Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection, hypersensitivity reactions including anaphylaxis.
Other Pain at injection site; local tissue irritation and induration following subcutaneous injection, particularly when repeated; antidiuretic effect.
Sedation:
Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals. Sedation may also occur partly because patients often recuperate from prolonged fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within three to five days and, if the sedation is not severe, will not require any treatment except reassurance.
If excessive sedation persists beyond a few days, the dose of the opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or […]
This is not medical advice. Consult a qualified healthcare professional.
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.
, 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 along with frequent reevaluation for signs of addiction, abuse, and misuse.
4 )] . Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing Meperidine Hydrochloride Tablets or Oral Solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug.
Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Meperidine Hydrochloride Tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product.
These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose or death. 3 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents , depending on the patient’s clinical status [see Overdosage ( 10 )] .
Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Meperidine Hydrochloride Tablets or Oral Solution, the risk is greatest during the initiation of therapy or following a dosage increase of Meperidine Hydrochloride Tablets or Oral Solution.
To reduce the risk of respiratory depression, proper dosing and titration of Meperidine Hydrochloride Tablets and Oral Solution are essential [see Dosage and Administration ( 2 )]. Overestimating the meperidine dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental ingestion of Meperidine Hydrochloride Tablets or Oral Solution, especially by children, can result in respiratory depression and death due to an overdose of meperidine. 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.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. 6 )]. , naloxone, nalmefene). , concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
4 )]. , prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Educate patients and caregivers on how to recognize respiratory depression, and how to use an opioid overdose reversal agent for the emergency treatment of opioid overdose.
4 ), Overdosage ( 10 )]. , non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin] , and other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions ( 7 )].
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation).
3 ), Overdosage ( 10 )]. Advise both patients and caregivers about the risks of respiratory depression and sedation when Meperidine Hydrochloride Tablets or Oral Solution is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs).
Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions ( 7 )].
5 Neonatal Opioid Withdrawal Syndrome Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. 1 )]. 6 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.
• Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medications are prescribed. gov/OpioidAnalgesicREMSPCG . • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.
• Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. com . gov/OpioidAnalgesicREMSBlueprint . , ritonavir), may increase plasma concentrations of meperidine and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Meperidine Hydrochloride Tablets or Oral Solution is achieved.
Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Meperidine Hydrochloride Tablets or Oral Solution-treated patients may increase meperidine plasma concentrations and prolong opioid adverse reactions.
When using Meperidine Hydrochloride Tablets and Oral Solution with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in meperidine-treated patients, evaluate patients at frequent intervals and consider dosage reduction of Meperidine Hydrochloride Tablets or Oral Solution until stable drug effects are achieved .
Concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease meperidine plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to meperidine.
When using Meperidine Hydrochloride Tablets or Oral Solution with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, evaluate patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see Drug Interactions ( 7 )].
8 Fatal Interaction with Monoamine Oxidase Inhibitors (MAOIs) 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 pre-existing 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.
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 has 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. 9 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.
3 )]. Symptoms of OIH include (but may not be limited to) increased levels of pain upon opioid dosage increase, decreased levels of pain upon opioid dosage decrease, or pain from ordinarily non-painful stimuli (allodynia). These symptoms may suggest OIH only if there is no evidence of underlying disease progression, opioid tolerance, opioid withdrawal, or addictive behavior.
Cases of OIH have been reported, both with short-term and longer-term use of opioid analgesics. Though the mechanism of OIH is not fully understood, multiple biochemical pathways have been implicated. Medical literature suggests a strong biologic plausibility between opioid analgesics and OIH and allodynia.
17 )] . 10 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of meperidine hydrochloride with serotonergic drugs.
Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), St. , cyclobenzaprine, metaxalone), and drugs that impair metabolism of serotonin (including MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see Drug Interactions ( 7 )].
This may occur within the recommended dosage range. , nausea, vomiting, diarrhea) and can be fatal. The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue Meperidine Hydrochloride Tablets or Oral Solution if serotonin syndrome is suspected.
11 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of Meperidine Hydrochloride Tablets or Oral Solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
3 )]. 3 )]. 3 ), Drug Interactions ( 7 )] . Alternatively, consider the use of non-opioid analgesics in these patients. 12 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
13 Severe Hypotension Meperidine Hydrochloride Tablets and Oral Solution may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. , phenothiazines or general anesthetics) [see Drug Interactions ( 7 )].
Regularly evaluate these patients for signs of hypotension after initiating or titrating the dosage of Meperidine Hydrochloride Tablets or Oral Solution. In patients with circulatory shock, Meperidine Hydrochloride Tablets and Oral Solution may cause vasodilation that can further reduce cardiac output and blood pressure.
Avoid the use of Meperidine Hydrochloride Tablets or Oral Solution in patients with circulatory shock. , those with evidence of increased intracranial pressure or brain tumors), Meperidine Hydrochloride Tablets and Oral Solution may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.
Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Meperidine Hydrochloride Tablets or Oral Solution. Opioids may also obscure the clinical course in a patient with a head injury.
Avoid the use of meperidine in patients with impaired consciousness or coma. 15 Risks of Gastrointestinal Complications Meperidine Hydrochloride Tablets and Oral Solution are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The meperidine in Meperidine Hydrochloride Tablets and Oral Solution may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Regularly evaluate patients with biliary tract disease, including pancreatitis, for worsening symptoms.
Cases of opioid-induced esophageal dysfunction (OIED) have been reported in patients taking opioids. The risk of OIED may increase as the dose and/or duration of opioids increases. , dysphagia, regurgitation, non-cardiac chest pain) and, if necessary, adjust opioid therapy as clinically appro priate .
16 Seizures Meperidine may increase the risk of having a seizure in patients with or without a pre-existing seizure disorder. Prolonged use of meperidine may also increase the risk of seizure due to the accumulation of the meperidine metabolite, normeperidine.
Frequently evaluate patients with a history of seizure disorder for worsening seizure control and advise patients and caregivers to get emergency medical help right away in the event of a known or suspected seizure. 17 Withdrawal Do not rapidly reduce or abruptly discontinue Meperidine Hydrochloride Tablets or Oral Solution in a patient physically dependent on opioids.
When discontinuing Meperidine Hydrochloride Tablets or Oral Solution in a physically dependent patient, gradually taper the dosage. 6 ), Drug Abuse and Dependence ( 9 )]. , buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Meperidine Hydrochloride Tablets and Oral Solution.
In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions ( 7 )]. 18 Risks of Driving and Operating Machinery Meperidine Hydrochloride Tablets and Oral Solution may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Meperidine Hydrochloride Tablets or Oral Solution and know how they will react to the medication. 19 Risks in Patients with Pheochromocytoma In patients with pheochromocytoma, meperidine has been reported to provoke hypertension.
20 Risk of Use in Patients with Atrial Flutter and Other Supraventricular Tachycardias Meperidine should be used with caution in patients with atrial flutter and other supraventricular tachycardias because of a possible vagolytic action which may produce a significant increase in the ventricular response rate.