DEMEROL (Page 7 of 10)

12.3 Pharmacokinetics

Elimination

The half-life of meperidine is 2 to 5 hours, and the half-life of normeperidine is 15 to 30 hours.

Metabolism

Meperidine is metabolized through biotransformation. In vitro data show meperidine is metabolized to normeperidine in liver mainly by CYP3A4 and CYP2B6.

Hepatic Impairment

The elimination half-life is 3 to 8 hours in healthy volunteers and is 1.3 to 2 times greater in post-operative or cirrhotic patients.

Excretion

Meperidine and normeperidine are excreted by kidneys.

Age

In clinical studies reported in the literature, changes in several pharmacokinetic parameters with increasing age have been observed. The initial volume of distribution and steady-state volume of distribution may be higher in elderly patients than in younger patients. The free fraction of meperidine in plasma may be higher in patients over 45 years of age than in younger patients.

Drug Interactions Studies

Phenytoin: The hepatic metabolism of meperidine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of meperidine in healthy subjects; however, blood concentrations of normeperidine were increased [see Drug Interactions (7)].

Ritonavir: Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir [see Drug Interactions (7)].

Acyclovir: Plasma concentrations of meperidine and its metabolite, normeperidine, may be increased by acyclovir [see Drug Interactions (7)].

Cimetidine: Cimetidine reduced the clearance and volume of distribution of meperidine and also the formation of the metabolite, normeperidine, in healthy subjects [see Drug Interactions (7)].

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate the carcinogenic potential of meperidine have not been conducted.

Mutagenesis

Studies in animals to evaluate the mutagenic potential of meperidine have not been conducted.

Impairment of Fertility

Studies to determine the effect of meperidine on fertility have not been conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING

For Parenteral Use

DEMEROL (meperidine hydrochloride injection), for subcutaneous, intramuscular, and intravenous use, is clear and colorless, and available as follows:

Unit of Sale Concentration (per total volume)

NDC 0409-1181-30 Carton of 130 mL fill in 30 mL Multiple-dose Vial

1,500 mg/30 mL(50 mg/mL)

NDC 0409-1176-30 Carton of 101 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock

25 mg/mL

NDC 0409-1178-30 Carton of 101 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock

50 mg/mL

NDC 0409-1179-30 Carton of 101 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock

75 mg/mL

NDC 0409-1180-69 Carton of 101 mL fill in 2.5 mL Carpuject Single-dose cartridge with Luer Lock

100 mg/mL

NDC 0409-1362-01 Clamshell of 101 mL fill in 1.5 mL NexJect™ Single-dosePrefilled Syringe with Luer Lock

25 mg/mL

NDC 0409-1418-01 Clamshell of 101 mL fill in 1.5 mL NexJect™ Single-dosePrefilled Syringe with Luer Lock

50 mg/mL

NDC 0409-2033-01 Clamshell of 101 mL fill in 1.5 mL NexJect™ Single-dosePrefilled Syringe with Luer Lock

75 mg/mL

NDC 0409-1377-01 Clamshell of 101 mL fill in 1.5 mL NexJect™ Single-dosePrefilled Syringe with Luer Lock

100 mg/mL

Carpuject Single-dose cartridge are packaged in a Slim-Pak tamper detection package. Note that a needle is not included.

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.]

17 PATIENT COUNSELING INFORMATION

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their health care provider if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.7), Drug Interactions (7)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.1)].

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Logo

LAB-0846-7.0

INSTRUCTIONS FOR USE

To Use NexJect™ Syringe

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(click image for full-size original)
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NOTE: To prevent needlestick injuries, needles and blunt cannulas should not be recapped, purposely bent, or broken by hand.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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LAB-1387-1.0

Revised: 9/2020

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