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ALPRAZOLAM XR Extended Release Tablets, C-IV (GREENSTONE LLC)

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ALPRAZOLAM XR Extended Release Tablets, C-IV (GREENSTONE LLC) 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, respiratory...
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1 INDICATIONS AND USAGE

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

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3 DOSAGE FORMS AND STRENGTHS

Alprazolam XR extended-release tablets are available as:

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

Alprazolam 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 Alprazolam 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 Alprazolam XR

Table 4 includes clinically significant drug interactions with Alprazolam 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

Alprazolam 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

Alprazolam 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 Alprazolam 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...

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16 HOW SUPPLIED/STORAGE AND HANDLING

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

...
Alprazolam XR Tablets
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MEDICATION GUIDE
Alprazolam XR
extended-release tablets, C-IV
This Medication Guide has been approved by the U.S. Food and Drug...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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