DEMEROL- meperidine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)

Available from:

Hospira, Inc.

INN (International Name):

MEPERIDINE HYDROCHLORIDE

Composition:

MEPERIDINE HYDROCHLORIDE 25 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve DEMEROL Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): DEMEROL Injection should not be used for an extended period of time unless the ‎pain remains severe enough to require an opioid analgesic and for which ‎alternative treatment options continue to be inadequate.‎ Use of DEMEROL Injection for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine. DEMEROL Injection is contraindicated in patients with: Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . Available data with DEMEROL Injection are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics (see Clinical ‎‎Considerations) . Formal animal reproduction studies have not been conducted with meperidine. Neural tube defects (exencephaly and cranioschisis) have been reported in hamsters administered a single bolus dose of meperidine during a critical period of organogenesis at 0.85 and 1.5 times the total human daily dose of 1200 mg. [see Data ] The background risk of major birth defects and miscarriage for the indicated population is unknown. All ‎‎pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. DEMEROL Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including DEMEROL Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Formal reproductive and developmental toxicology studies for meperidine have not been completed. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of meperidine hydrochloride (127 and 218 mg/kg, respectively) on Gestation Day 8 to pregnant hamsters (0.85 and 1.5 times the total daily dose of 1200 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity. Risk Summary Meperidine appears in the milk of nursing mothers receiving the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEMEROL Injection and any potential adverse effects on the breastfed infant from DEMEROL Injection or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to DEMEROL Injection through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6), Clinical Pharmacology (12.2), Nonclinical Pharmacology (13.1)]. 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. 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. 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. 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. DEMEROL Injection contains meperidine, a Schedule II controlled substance. 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. Risks Specific to Abuse of DEMEROL Injection Abuse of DEMEROL Injection poses a risk of overdose and death. The risk is increased with concurrent abuse of DEMEROL Injection with alcohol and/or other CNS depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. 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)] . 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

Product summary:

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: NDC 0409-1181-30 Carton of 1 30 mL fill in 30 mL Multiple-dose Vial 1,500 mg/30 mL (50 mg/mL) NDC 0409-1176-30 Carton of 10 1 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock 25 mg/mL NDC 0409-1178-30 Carton of 10 1 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock 50 mg/mL NDC 0409-1179-30 Carton of 10 1 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock 75 mg/mL NDC 0409-1180-69 Carton of 10 1 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock 100 mg/mL NDC 0409-1362-01 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 25 mg/mL NDC 0409-1418-01 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 50 mg/mL 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. Carpuject and NexJectTM Single-dose products: Discard unused portion. Multiple-dose vials: Discard unused portion after 28 days. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

Authorization status:

New Drug Application

Summary of Product characteristics

DEMEROL- MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEMEROL™ INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEMEROL
INJECTION.
DEMEROL (MEPERIDINE HYDROCHLORIDE INJECTION), FOR SUBCUTANEOUS,
INTRAMUSCULAR, AND
INTRAVENOUS USE, CII
INITIAL U.S. APPROVAL: 1942
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DEMEROL
​INJECTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Boxed Warning
12/2023
Indications and Usage (1)
12/2023
Dosage and Administration (2.1, 2.2)​
12/2023
Warnings and Precautions (5.7)​
12/2023
INDICATIONS AND USAGE
DEMEROL Injection is indicated for preoperative medication, support of
anesthesia, for obstetrical
analgesia, and for the management of pain severe enough to require an
opioid analgesic and for which
alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids,
which can occur at any dosage or
duration (5.1), reserve DEMEROL Injection for use in patients for whom
alternative treatment options [e.g.,
non-opioid analgesics or opioid combination products]:
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DEMEROL Injection should not be used for an extended period of time
unless the ​pain remains severe
enough to require an opioid analgesic and for which ​alternative
treatment options continue to be
DEMEROL INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND
MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND
REASSESS REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1)
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.​ (5.2)
CONCOMITANT USE OF OPIOIDS WITH BENZO