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alfentanil injection, USP Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ADDICTION, ABUSE, AND MISUSE

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

2.2 Dosage

2.3 Discontinuation of Alfentanil Injection

2.4 Dosage Modification in Elderly Patients

2.5 Dosage Modifications in Obese Patients

2.6 Dosage Modifications with Concomitant Use with Other CNS Depressants

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

5.4 Risks of Muscle Rigidity and Skeletal Muscle Movement

5.5 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

5.6 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs

5.7 Potentiation of Monoamine Oxidase Inhibitors

5.8 Bradycardia

5.9 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury

5.10 Risks of Use in Patients with Gastrointestinal Conditions

5.11 Increased Risk of Seizures in Patients with Convulsive or Seizure Disorders

5.12 Risks due to Hypersensitivity Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

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

8.8 Respiratory 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

HOW SUPPLIED

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