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XANAX®, CIV (alprazolam)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

XANAX®, CIV Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

  • Concomitant use of benzodiazepines and opioids may result in profound sedation...
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1 INDICATIONS AND USAGE

XANAX is indicated for the:

  • acute treatment of generalized anxiety disorder (GAD) in adults.
  • treatment of panic disorder (PD), with or without agoraphobia in adults.
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2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Generalized Anxiety Disorder

The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0...

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3 DOSAGE FORMS AND STRENGTHS

XANAX tablets are available as:

  • 0.25 mg: white, oval, scored, imprinted "XANAX 0.25"
  • 0.5 mg: peach, oval, scored, imprinted "XANAX 0.5"
  • 1 mg: blue,...
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4 CONTRAINDICATIONS

XANAX is contraindicated in patients:

  • with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see ...
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5 WARNINGS AND PRECAUTIONS

5.1 Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including XANAX, and opioids may result in profound...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Risks from Concomitant Use with Opioids [see

    6.1...

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7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with XANAX

Table 4 includes clinically significant drug interactions with XANAX...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

XANAX contains alprazolam, which is a Schedule IV controlled substance.

...
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10 OVERDOSAGE

10.1 Clinical Experience

Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma....

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11 DESCRIPTION

XANAX contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Generalized Anxiety Disorder

XANAX was compared to placebo in double-blind clinical studies (doses up to 4 mg per day) in patients with a...

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16 HOW SUPPLIED/STORAGE AND HANDLING

XANAX is supplied in the following strengths and package configurations:

...
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MEDICATION GUIDE
XANAX (ZAN-aks)
(alprazolam)...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

...

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