Alprazolam

Alprazolam
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Alprazolam is a Benzodiazepine that is FDA approved for the treatment of ［［Anxiety Disorders］］，Panic Disorder. Common adverse reactions include Decrease in appetite，Increased appetite，Weight increased，［［Constipation］］，Reduced salivation，［［Xerostomia］］，［［Cognitive disorder］］，［［Confusion］］，［［Dysarthria］］，［［Incoordination］］，［［Lightheadednes］］，Memory，impairment，Sedated，［［Somnolence］］，［［Irritability］］，Reduced libido，［［Fatigue］］.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Anxiety Disorders and Transient Symptoms of Anxiety

• Dosing information

• Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

• In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

Panic Disorder

• Dosing information

• The successful treatment of many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.

Dose Titration

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alprazolam in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alprazolam in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Alprazolam FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alprazolam in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alprazolam in pediatric patients.

Contraindications

There is limited information regarding Alprazolam Contraindications in the drug label.

Warnings

There is limited information regarding Alprazolam Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Alprazolam Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Alprazolam Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Alprazolam Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Alprazolam in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alprazolam in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Alprazolam during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Alprazolam in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Alprazolam in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Alprazolam in geriatric settings.

Gender

There is no FDA guidance on the use of Alprazolam with respect to specific gender populations.

Race

There is no FDA guidance on the use of Alprazolam with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Alprazolam in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Alprazolam in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Alprazolam in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Alprazolam in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Alprazolam Administration in the drug label.

Monitoring

There is limited information regarding Alprazolam Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Alprazolam and IV administrations.

Overdosage

There is limited information regarding Alprazolam overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Alprazolam Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Alprazolam Mechanism of Action in the drug label.

Structure

There is limited information regarding Alprazolam Structure in the drug label.

Pharmacodynamics

There is limited information regarding Alprazolam Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Alprazolam Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Alprazolam Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Alprazolam Clinical Studies in the drug label.

How Supplied

There is limited information regarding Alprazolam How Supplied in the drug label.

Storage

There is limited information regarding Alprazolam Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Alprazolam Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Alprazolam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Alprazolam Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Alprazolam Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.