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DEMEROL Index Section (Meperidine Hydrochloride Injection, USP)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and MONOAMINE OXIDASE (MOA) INHIBITORS INTERACTIONS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

2.2 For Management of Pain

2.3 For Preoperative Medication

2.4 For Support of Anesthesia

2.5 For Obstetrical Analgesia

2.6 Dosage Modifications with Concomitant Phenothiazines

2.7 Instructions for Use of the Syringe Systems

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

5.2 Life-Threatening Respiratory Depression

5.3 Neonatal Opioid Withdrawal Syndrome

5.4 Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

5.5 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

5.6 Fatal Interaction with Monoamine Oxidase Inhibitors

5.7 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

5.8 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs

5.9 Adrenal Insufficiency

5.10 Severe Hypotension

5.11 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

5.12 Risks of Use in Patients with Gastrointestinal Conditions

5.13 Increased Risk of Seizures in Patients with Seizure Disorders

5.14 Withdrawal

5.15 Risks of Driving and Operating Machinery

5.16 Risks in Patients with Pheochromocytoma

5.17 Risk of Use in Patients with Atrial Flutter and Other Supraventricular Tachycardias

5.18 Intravenous Use

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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