Alprazolam
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.