^ For Obstetrical Analgesia
The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously when pain becomes regular, and may be repeated at 1- to 3-hour intervals.
^ Life-threatening Respiratory Depression In Patients With Chronic Pulmonary Disease Or In Elderly, Cachectic, Or Debilitated Patients
The use of DEMEROL Injection in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease: DEMEROL Injection treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of DEMEROL Injection [see Warnings and Precautions (5.2)].
Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2)].
Monitor such patients closely, particularly when initiating and titrating DEMEROL Injection and when DEMEROL Injection is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2)].
Alternatively, consider the use of non-opioid analgesics in these patients.
^ Abuse
DEMEROL Injection contains meperidine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1)].
Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed.
Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of DEMEROL Injection increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of DEMEROL Injection with alcohol and/or other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction.
All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of DEMEROL Injection abuse include those with a history of prolonged use of any opioid, including products containing meperidine, those with a history of drug or alcohol abuse, or those who use DEMEROL Injection in combination with other abused drugs.
“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control.
DEMEROL Injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
^ Patient Counseling Information
Addiction, Abuse, and Misuse
Inform patients that the use of DEMEROL Injection, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share DEMEROL Injection with others and to take steps to protect DEMEROL Injection 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 DEMEROL Injection or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.2)].
Hyperalgesia and Allodynia
Advise patients to inform their healthcare provider if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see Warnings and Precautions (5.7), Adverse Reactions (6)].
^ Description
DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure.
Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water.
DEMEROL (meperidine hydrochloride injection) is available as:
Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent.
Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection.
Single-dose NexJect™ Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent.
The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0.
DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.
^Principal Display Panel - Mg/ml Cartridge Carton
NDC 0409-1176-30Contains 10 of NDC 0409-1176-03Rx only
1 mL Single-dose
10 Carpuject™Sterile Cartridge Unitswith Luer Lock
Needle not included
SLIM-PAK™Tamper Detection Package
Demerol™meperidinehydrochlorideinjection, USP25 mg/mLCII
For Intramuscular, Subcutaneous, orIntravenous Use
Carpuject Cartridges are to be usedONLY with Carpuject Holders.
Dist. by Hospira, Inc.,Lake Forest, IL60045 USAHospira
^ Risk Of Use In Patients With Atrial Flutter And Other Supraventricular Tachycardias
DEMEROL Injection 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.
^ Risks From Concomitant Use With Benzodiazepines Or Other Cns Depressants
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of DEMEROL Injection with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, 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. Monitor patients closely for signs and symptoms of respiratory depression and sedation.
Advise both patients and caregivers about the risks of respiratory depression and sedation when DEMEROL Injection 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)].
^ Risks Of Use In Patients With Gastrointestinal Conditions
DEMEROL Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The meperidine in DEMEROL Injection may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
^Principal Display Panel - Mg/ml Syringe Luer Label
TWIST & PULL
Tamper Seal
NDC 0409-1362-11CII
Demerol™meperidine HCl injection, USP
25 mg/mL
Intramuscular,Subcutaneous, orIntravenous UseRx only
1 mL Single-dose syringe
PAA148096
LOT #####AAEXP DMMMYYYY
^ Hepatic Impairment
Accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with hepatic impairment. Elevated serum levels have been reported to cause central nervous system excitatory effects. Meperidine should therefore be used with caution in patients with hepatic impairment. Titrate the dosage of DEMEROL Injection slowly in patients with hepatic impairment and monitor closely for signs of central nervous system and respiratory depression.
^ 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 antagonists, depending on the patient's clinical status [see Overdosage (10)]. Carbon dioxide (CO2) 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 DEMEROL Injection, the risk is greatest during the initiation of therapy or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of DEMEROL Injection are essential [see Dosage and Administration (2.3)]. Overestimating the DEMEROL Injection dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
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. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration (2.2)].
^ 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.
^ Risks In Patients With Pheochromocytoma
In patients with pheochromocytoma, meperidine has been reported to provoke hypertension.
^4 Contraindications
DEMEROL Injection is contraindicated in patients with:
^ 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 with serotonergic drugs. Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and drugs that impair metabolism of serotonin (including MAO inhibitors, 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.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., 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 DEMEROL Injection if serotonin syndrome is suspected.
^Principal Display Panel - Mg/ml Cartridge Carton
NDC 0409-1178-30Contains 10 of NDC 0409-1178-03Rx only
1 mL Single-dose
10 Carpuject™Sterile Cartridge Unitswith Luer Lock
Needle not included
SLIM-PAK™Tamper Detection Package
Demerol™meperidinehydrochlorideinjection, USP50 mg/mLCII
For Intramuscular, Subcutaneous, orIntravenous Use
Carpuject Cartridges are to be usedONLY with Carpuject Holders.
Dist. by Hospira, Inc.Lake Forest, IL 60045 USAHospira
^ Intravenous Use
If necessary, meperidine may be given intravenously, but the injection should be given very slowly, preferably in the form of a diluted solution. Rapid intravenous injection of narcotic analgesics, including meperidine, increases the incidence of adverse reactions; severe respiratory depression, apnea, hypotension, peripheral circulatory collapse, and cardiac arrest have occurred. Meperidine should not be administered intravenously unless a narcotic antagonist and the facilities for assisted or controlled respiration are immediately available. When meperidine is given parenterally, especially intravenously, the patient should be lying down.
^Principal Display Panel - Mg/ml Syringe Luer Label
TWIST & PULL
Tamper Seal
NDC 0409-1418-11CII
Demerol™meperidine HCl injection, USP
50 mg/mL
Intramuscular,Subcutaneous, orIntravenous UseRx only1 mL Single-dose syringe
PAA148099
LOT #####AAEXP DMMMYYYY
^Principal Display Panel - Mg/ml Cartridge Label
1 mL Single-dose Carpuject™Sterile Cartridge Unit with Luer Lock
Rx onlyNDC 0409-1179-03
Demerol™meperidine HCl injection, USP75 mg/mLCII
Dist. by Hospira, Inc., Lake Forest, IL 60045 USAHospira
PAA198799
#####AADMMMYYYY
^Warning: Serious And Life-threatening Risks From Use Of Demerol
Addiction, Abuse, and Misuse
Because the use of DEMEROL Injection 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 (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DEMEROL Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of DEMEROL Injection are essential [see Warnings and Precautions (5.2)].
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 DEMEROL Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].
Neonatal Opioid Withdrawal Syndrome (NOWS)
If opioid use is required for an extended period of time in a pregnant woman, advise the patient 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 (5.4)].
Cytochrome P450 3A4 Interaction
The concomitant use of DEMEROL Injection with all cytochrome P450 3A4 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 inducer may result in an increase in meperidine plasma concentration. Monitor patients receiving DEMEROL Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.5), Drug Interactions (7)].
Concomitant Use of DEMEROL Injection with Monoamine Oxidase (MAO) Inhibitors
Concomitant use of DEMEROL Injection with monoamine oxidase (MAO) inhibitors can result in coma, severe respiratory depression, cyanosis, and hypotension. Use of DEMEROL Injection with MAO inhibitors within last 14 days is contraindicated [see Contraindications (4), Warnings and Precautions (5.6), Drug Interactions (7)].
^Principal Display Panel - Mg/ml Cartridge Label
1 mL Single-dose Carpuject™Sterile Cartridge Unit with Luer Lock
Rx onlyNDC 0409-1178-03
Demerol™meperidine HCl injection, USP50 mg/mLCII
Dist. by Hospira, Inc., Lake Forest, IL 60045 USAHospira
PAA198798
#####AADMMMYYYY
^ Withdrawal
Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including DEMEROL Injection. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms.
When discontinuing DEMEROL Injection, gradually taper the dosage [see Dosage and Administration (2.2)]. Do not abruptly discontinue DEMEROL Injection [see Drug Abuse and Dependence (9.3)].
^ Controlled Substance
DEMEROL Injection contains meperidine, a Schedule II controlled substance.
^ Neonatal Opioid Withdrawal Syndrome
Use of DEMEROL Injection 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. Advise pregnant women using opioids for an extended period of time of the risk of neonatal opioid withdrawal syndrome and ensure that management by neonatology experts will be available at delivery [see Use in Specific Populations (8.1)].
^ Risks Of Concomitant Use Or Discontinuation Of Cytochrome P 3a4 Inhibitors And Inducers
Concomitant use of DEMEROL Injection with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of meperidine and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.2)], particularly when an inhibitor is added after a stable dose of DEMEROL Injection is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in DEMEROL Injection treated patients may increase meperidine plasma concentrations and prolong opioid adverse reactions. When using DEMEROL Injection with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in DEMEROL Injection treated patients, monitor patients closely at frequent intervals and consider dosage reduction of DEMEROL Injection until stable drug effects are achieved [see Drug Interactions (7)].
Concomitant use of DEMEROL Injection 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 DEMEROL Injection with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor 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)].
^ Risks Of Use In Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, Or Impaired Consciousness
In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), DEMEROL Injection may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for worsening of signs of increasing intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with DEMEROL Injection.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of DEMEROL Injection in patients with impaired consciousness or coma.
^ Fatal Interaction With Monoamine Oxidase Inhibitors
Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors 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 narcotic 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 DEMEROL Injection 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 narcotic antagonists in the treatment of these reactions is unknown.
^ Addiction, Abuse, And Misuse
DEMEROL Injection contains meperidine, a Schedule II controlled substance. As an opioid, DEMEROL Injection exposes 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 DEMEROL Injection. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing DEMEROL Injection, and monitor all patients receiving DEMEROL Injection 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 DEMEROL Injection but use in such patients necessitates intensive counseling about the risks and proper use of DEMEROL Injection along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. 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.
^Principal Display Panel - Mg/ml Cartridge Label
1 mL Single-dose Carpuject™Sterile Cartridge Unit with Luer Lock
Rx onlyNDC 0409-1176-03
Demerol™meperidine HCl injection, USP25 mg/mLCII
Dist. by Hospira, Inc., Lake Forest, IL 60045 USAHospira
PAA198797
#####AADMMMYYYY
^Principal Display Panel - Ml Vial Carton
NDC 0409-1181-30Rx onlyNSN 6505-00-126-9360
30 mL Multiple-dose vial
Demerol™meperidinehydrochlorideinjection, USP1500 mg/30 mL(50 mg/mL)CII
For Intramuscular, Subcutaneous,or Intravenous Use
Sterile Aqueous Injection
Hospira
^Principal Display Panel - Mg/ml Syringe Chamber Label
Demerol™meperidine HCl injection, USPCII25 mg/mLPAA148095
^ For Support Of Anesthesia
Repeated slow intravenous Injections of fractional doses (e.g., 10 mg/mL) or continuous intravenous infusion of a more dilute solution (e.g., 1 mg/mL) should be used. The dose should be titrated to the needs of the patient and will depend on the premedication and type of anesthesia being employed, the characteristics of the particular patient, and the nature and duration of the operative procedure. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.
^Principal Display Panel - Mg/ml Syringe Cello Pack
NDC 0409-1362-01Demerol™CIImeperidine hydrochlorideinjection, USP
25 mg / mL
For Intramuscular, Subcutaneous, or Intravenous Use
10 NexJect™ 1 mL Single-dose syringes with luer lockRx onlyNeedle not included
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]Sterile Aqueous Injection
Each mL contains 25 mg meperidine hydrochloride (equivalent to 21.79 mgmeperidine), 3.8 mg sodium chloride for isotonicity, NaOH and HCl for pHadjustment, in water for injection.
For usual pediatric dosage and route of administration, see package insert.Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.
PAA189910Distributed by Hospira, Inc.Lake Forest, IL 60045 USAHospira
^ Dependence
Both tolerance and physical dependence can develop during use of opioid therapy.
Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use.
DEMEROL Injection should not be abruptly discontinued in a physically-dependent patient [see Dosage and Administration (2.4)]. If DEMEROL Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, 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.
Infants born to mothers physically-dependent on opioids will also be physically-dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].
^Principal Display Panel - Ml Vial Label
30 mLMultiple-dose vial
NDC 0409-1181-30Rx only
Sterile Aqueous Injection
Demerol™meperidine hydrochloride injection, USP1500 mg/30 mL (50 mg/mL)CII
For Intramuscular, Subcutaneous, or Intravenous Use
Distributed byHospira, Inc., Lake Forest, IL 60045 USAHospira
^3 Dosage Forms And Strengths
DEMEROL Injection is a clear, colorless, sterile aqueous solution, available in the following dosage forms and strengths:
^ 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. This condition differs from tolerance, which is the need for increasing doses of opioids to maintain a defined effect [see Dependence (9.3)]. 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. If a patient is suspected to be experiencing OIH, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation (safely switching the patient to a different opioid moiety) [see Dosage and Administration (2), Warnings and Precautions (5.15)].
^ Pediatric Use
The safety and efficacy of DEMEROL Injection in patients less than 18 years of age have not been established.
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.
^ Increased Risk Of Seizures In Patients With Seizure Disorders
The meperidine in DEMEROL Injection may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during DEMEROL Injection therapy. Prolonged meperidine use may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.
^ How Supplied/storage And Handling
For Parenteral Use
DEMEROL (meperidine hydrochloride injection) is clear and colorless.
DEMEROL (meperidine hydrochloride injection) is supplied as a sterile solution in a multiple-dose vial, single-dose Carpuject™ cartridges for use ONLY with the Carpuject™ Holders and NexJect™ prefilled syringes for subcutaneous, intramuscular, and intravenous administration, and available as follows:
Carpuject™ Single-dose cartridges are packaged in a Slim-Pak tamper detection package.
Note that a needle is not included with Carpuject™ Single-dose cartridges and Nexject™ Single-dose Prefilled Syringes.
CarpujectTM and NexJectTM Single-dose products: Discard unused portion.
Multiple-dose vials: Discard unused portion after 28 days.
^ Geriatric Use
Elderly patients (aged 65 years or older) may have increased sensitivity to meperidine. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
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 DEMEROL Injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.2)].
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 monitor renal function.
^ Renal Impairment
Accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment. Titrate the dosage of DEMEROL Injection slowly in patients with renal impairment and monitor closely for signs of central nervous system and respiratory depression.
^Principal Display Panel - Mg/ml Syringe Cello Pack
NDC 0409-1418-01Demerol™CIImeperidine hydrochlorideinjection, USP
50 mg / mL
For Intramuscular, Subcutaneous, or Intravenous Use
10 NexJect™ 1 mL Single-dose syringes with luer lockRx onlyNeedle not included
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]Sterile Aqueous Injection
Each mL contains 50 mg meperidine hydrochloride (equivalent to 43.58 mgmeperidine), NaOH and HCl for pH adjustment, in water for injection.For usual dosage and route of administration, see package insert.Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.
PAA189961Distributed by Hospira, Inc.Lake Forest, IL 60045 USAHospira
^Principal Display Panel - Mg/ml Cartridge Label
1 mL Single-dose Carpuject™Sterile Cartridge Unit with Luer Lock
Rx onlyNDC 0409-1180-59
Demerol™meperidine HCl injection, USP100 mg/mLCII
Dist. by Hospira, Inc., Lake Forest, IL 60045 USAHospira
PAA198800
#####AADMMMYYYY
^Principal Display Panel - Mg/ml Cartridge Carton
NDC 0409-1180-69Contains 10 of NDC 0409-1180-59Rx only
1 mL Single-dose
10 Carpuject™Sterile Cartridge Unitswith Luer Lock
Needle not included
SLIM-PAK™Tamper Detection Package
Demerol™meperidinehydrochlorideinjection, USP100 mg/mLCII
For Intramuscular, Subcutaneous, orIntravenous Use
Carpuject Cartridges are to be usedONLY with Carpuject Holders.
Dist. by Hospira, Inc.,Lake Forest, IL 60045 USAHospira
^Principal Display Panel - Mg/ml Cartridge Carton
NDC 0409-1179-30Contains 10 of NDC 0409-1179-03Rx only
1 mL Single-dose
10 Carpuject™Sterile Cartridge Unitswith Luer Lock
Needle not included
SLIM-PAK™Tamper Detection Package
Demerol™meperidinehydrochlorideinjection, USP75 mg/mLCII
For Intramuscular, Subcutaneous, orIntravenous Use
Carpuject Cartridges are to be usedONLY with Carpuject Holders.
Dist. by Hospira, Inc.Lake Forest, IL 60045 USAHospira
^ Important Dosage And Administration Instructions
^6 Adverse Reactions
The following serious adverse reactions are described, or described in greater detail, in other sections:
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 have occurred.
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.
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, transient hallucinations and disorientation, confusion, delirium, visual disturbances.
Inadvertent injection about 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 and Precautions (5.18)], syncope, phlebitis following intravenous injection. 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. Other: Pain at injection site; local tissue irritation and induration following subcutaneous injection, particularly when repeated; antidiuretic effect. 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 (5.7)]. 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).
^ Severe Hypotension
DEMEROL Injection may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of DEMEROL Injection. In patients with circulatory shock, DEMEROL Injection may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of DEMEROL Injection in patients with circulatory shock.
^7 Drug Interactions
Table 1 includes clinically significant drug interactions with DEMEROL Injection.
^ Dosage Modifications With Concomitant Phenothiazines
The dose of DEMEROL Injection should be proportionately reduced (usually by 25 to 50 percent) when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of DEMEROL Injection.
^1 Indications And Usage
DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia.
DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
^Principal Display Panel - Mg/ml Syringe Chamber Label
Demerol™meperidine HCl injection, USPCII50 mg/mLPAA148098
^ Mechanism Of Action
Meperidine hydrochloride 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.
^ Risks Of Driving And Operating Machinery
DEMEROL Injection 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 DEMEROL Injection and know how they will react to the medication.
^Instructions For Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate.
Instructions for use - Carpuject™ Single-dose Cartridge
Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included.
Before use, read all instructions for using the Carpuject™ Syringe, which are contained in the product insert for the reusable Carpuject™ Holder before use.
Carpuject™ Single-dose cartridges are to be used ONLY with Carpuject™ Holders.
NOTE: To prevent needlestick injuries, do not recap, purposely bend, or break by hand used needles. Do not recap, purposely bend, or break by hand blunt Cannulas.
Instructions for use - NexJect™ Single-dose Prefilled Syringe
NOTE: To prevent needlestick injuries, do not recap, purposely bend, or break by hand used needles. Do not recap, purposely bend, or break by hand blunt Cannulas.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1387-2.0
Revised: 12/2023
