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XANAX®, CIV Index Section (alprazolam)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Generalized Anxiety Disorder

2.2 Dosage in Panic Disorder

2.3 Discontinuation or Dosage Reduction of XANAX

2.4 Dosage Recommendations in Geriatric Patients

2.5 Dosage Recommendations in Patients with Hepatic Impairment

2.6 Dosage Modifications for Drug Interactions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Risks from Concomitant Use with Opioids

5.2 Abuse, Misuse, and Addiction

5.3 Dependence and Withdrawal Reactions

5.4 Effects on Driving and Operating Machinery

5.5 Neonatal Sedation and Withdrawal Syndrome

5.6 Interaction with Drugs that Inhibit Metabolism via Cytochrome P450 3A

5.7 Patients with Depression

5.8 Mania

5.9 Risk in Patients with Impaired Respiratory Function

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with XANAX

7.2 Drug/Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

10.1 Clinical Experience

10.2 Management of Overdose

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Generalized Anxiety Disorder

14.2 Panic Disorder

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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