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XANAX® XR, CIV Highlights (alprazolam)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

XANAX® XR (alprazolam) extended-release 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 of these drugs 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 XR, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing XANAX XR and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. (5.2)
  • Abrupt discontinuation or rapid dosage reduction of XANAX XR 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 XR or reduce the dosage. (2.2, 5.3)

RECENT MAJOR CHANGES

Boxed Warning2/2021
Dosage and Administration (2.2)2/2021
Warnings and Precautions (5.2, 5.3)2/2021

INDICATIONS AND USAGE

XANAX XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. (1)

DOSAGE AND ADMINISTRATION

  • Recommended starting oral dosage is 0.5 mg to 1 mg once daily (preferably in the morning). Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg daily. (2.1)
  • Recommended total daily dosage is 3 mg to 6 mg daily. (2.1)
  • Swallow tablets whole; do not divide, crush, or chew. (2.1)
  • When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. (2.2, 5.2)
  • See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir. (2.3, 2.4, 2.5)

DOSAGE FORMS AND STRENGTHS

Extended Release Tablets: 0.5 mg, 1 mg, 2 mg, and 3 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 XR 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 XR 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 in panic disorder patients treated with XANAX XR (incidence of ≥ 5% and at least twice that of placebo) include: somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased, constipation, and nausea. (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 ritinovir): Increase the risk of adverse reactions of alprazolam. (4, 5.5, 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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