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XANAX®, CIV Highlights (alprazolam)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use XANAX safely and effectively. See full prescribing information for XANAX.

XANAX (alprazolam) tablets, for oral use, CIV
Initial U.S. Approval: 1981

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

See full prescribing information for complete boxed warning.

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. (5.1, 7.1)
  • The use of benzodiazepines, including XANAX, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing XANAX and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. (5.2)
  • Abrupt discontinuation or rapid dosage reduction of XANAX after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. (2.2, 5.3)

RECENT MAJOR CHANGES

Boxed Warning2/2021
Dosage and Administration (2.3)2/2021
Warnings and Precautions (5.2, 5.3)2/2021

INDICATIONS AND USAGE

XANAX is a benzodiazepine indicated for the:

  • Acute treatment of generalized anxiety disorder in adults. (1)
  • Treatment of panic disorder with or without agoraphobia in adults. (1)

DOSAGE AND ADMINISTRATION

  • Generalized Anxiety Disorder: (2.1)
    • Recommended starting oral dosage is 0.25 mg to 0.5 mg three times daily.
    • Dosage may be increased, at intervals of every 3 to 4 days, to a maximum recommended daily dose of 4 mg, given in divided doses.
    • Use the lowest possible effective dose and frequently assess the need for continued treatment.
  • Panic Disorder: Recommended starting oral dosage is 0.5 mg three times daily. The dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day. (2.2)
  • When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. (2.3, 5.2)
  • See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir. (2.4, 2.5, 2.6)

DOSAGE FORMS AND STRENGTHS

Tablets: 0.25 mg, 0.5 mg, 1 mg, and 2 mg (3)

CONTRAINDICATIONS

  • Known hypersensitivity to alprazolam or other benzodiazepines. (4)
  • Concomitant use with strong cytochrome P450 3A (CYP3A) inhibitors, except ritonavir. (4, 5.5, 7.1)

WARNINGS AND PRECAUTIONS

  • Effects on Driving and Operating Machinery: Patients receiving XANAX should be cautioned against operating machinery or driving a motor vehicle, as well as avoiding concomitant use of alcohol and other central nervous system (CNS) depressant drugs. (5.4)
  • Neonatal Sedation and Withdrawal Syndrome (NOWS): Use of XANAX during pregnancy can result in neonatal sedation and neonatal withdrawal syndrome. (5.5, 8.1)
  • Patients with Depression: Exercise caution in patients with signs or symptoms of depression. Prescribe the least number of tablets feasible to avoid intentional overdosage. (5.7)

ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence ≥5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Use with Opioids: Increase the risk of respiratory depression. (7.1)
  • Use with Other CNS Depressants: Produces additive CNS depressant effects. (7.1)
  • Use with Digoxin: Increase the risk of digoxin toxicity. (7.1)
  • Use with CYP3A Inhibitors (except ritonavir): Increase the risk of adverse reactions of alprazolam. (4, 5.6, 7.1)
  • Use with CYP3A Inducers: Increase the risk of reduced efficacy of alprazolam. (7.1)

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding not recommended. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2021

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