XANAX® XR, CIV How Supplied/Storage and Handling (alprazolam) | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

XANAX XR is supplied in the following strengths and package configurations:

XANAX XR Tablets
Package Configuration	Tablet Strength (mg)	NDC	Print
Bottles of 60	0.5 mg	NDC 0009-0057-07	white, pentagonal shaped tablets debossed with an "X" on one side and "0.5" on the other side
Bottles of 60	1 mg	NDC 0009-0059-07	yellow, square shaped tablets debossed with an "X" on one side and "1" on the other side
Bottles of 60	2 mg	NDC 0009-0066-07	blue, round shaped tablets debossed with an "X" on one side and "2" on the other side
Bottles of 60	3 mg	NDC 0009-0068-07	green, triangular shaped tablets debossed with an "X" on one side and "3" on the other side

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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® XR, CIV Quick Finder

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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, respiratory...

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1 INDICATIONS AND USAGE

XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Administer XANAX XR orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or...

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3 DOSAGE FORMS AND STRENGTHS

XANAX XR extended-release tablets are available as:

0.5 mg: white, pentagonal shaped tablets debossed with an "X" on one side and "0.5" on the other side
1 mg:...

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4 CONTRAINDICATIONS

XANAX XR 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 XR, 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 XR

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

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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 XR 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 XR 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-4...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the treatment of panic disorder through binding...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

The efficacy of XANAX XR in the treatment of panic disorder in adults was established in two 6-week, flexible-dose, placebo-controlled studies in adult patients meeting DSM-III criteria for panic disorder...

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16 HOW SUPPLIED/STORAGE AND HANDLING

XANAX XR is supplied in the following strengths and package configurations:

...

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MEDICATION...

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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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Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.