Alprazolam Extended Release .5 mg/1
Alprazolam · TABLET, EXTENDED RELEASE · Bryant Ranch Prepack
Alprazolam Extended Release is a tablet, extended release containing alprazolam at .5 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Alprazolam Extended Release
- Generic Name
- Alprazolam
- NDC Code (Product)
72162-1059- Manufacturer
- Bryant Ranch Prepack
- Strength
- .5 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA078056
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 03/12/2007
Recall History
Actavis Elizabeth LLC
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Viatris Inc
Failed Dissolution Specifications: low out of specification results for dissolution.
Mylan Pharmaceuticals Inc.
Failed Dissolution Specifications
Viatris, Inc.
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended starting oral dosage is 0.5 mg to 1 mg once daily (preferably in the morning). Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg daily. ( 2.1 ) Recommended total daily dosage is 3 mg to 6 mg daily. ( 2.1 ) Swallow tablets whole; do not divide, crush, or chew. ( 2.1 ) When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. ( 2.2 , 5.2 ) See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir. ( 2.3 , 2.4 , 2.5 ) 2.1 Recommended Dosage Administer alprazolam extended-release tablets orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or chew. The recommended starting oral dosage for alprazolam extended-release tablets is 0.5 mg to 1 mg once daily. Depending on the response, the dosage may be adjusted at intervals of every 3 to 4 days in increments of no more than 1 mg daily. The recommended dosage range is 3 mg to 6 mg once daily. Controlled trials of alprazolam extended-release ta…
Contraindications
4 CONTRAINDICATIONS Alprazolam extended-release tablets are contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions ( 6.2 )]. taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.5 ), Drug Interactions ( 7.1 )] . Known hypersensitivity to alprazolam or other benzodiazepines. ( 4 ) Concomitant use with strong cytochrome P450 3A (CYP3A) inhibitors, except ritonavir. ( 4 , 5.5 , 7.1 )
Drug Interactions
7 DRUG INTERACTIONS Use with Opioids: Increase the risk of respiratory depression. ( 7.1 ) Use with Other CNS Depressants: Produces additive CNS depressant effects. ( 7.1 ) Use with Digoxin: Increase the risk of digoxin toxicity. ( 7.1 ) Use with CYP3A Inhibitors (except ritinovir): Increase the risk of adverse reactions of alprazolam. ( 4 , 5.5 , 7.1 ) Use with CYP3A Inducers: Increase the risk of reduced efficacy of alprazolam. ( 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Alprazolam Extended-Release Tablets Table 4 includes clinically significant drug interactions with alprazolam extended-release tablets [see Clinical Pharmacology ( 12.3 )] . Table 4: Clinically Significant Drug Interactions with Alprazolam Extended-Release Tablets Opioids Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at gamma-aminobutyric acid (GABA A ) sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Effects on Driving and Operating Machinery [see Warnings and Precautions ( 5.4 )] Patients with Depression [see Warnings and Precautions ( 5.6 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.8 )] Risks in Patients with Impaired Respiratory Function [see Warnings and Precautions ( 5.9 )] The most common adverse reactions in panic disorder patients treated with alprazolam extended-release tablets (incidence of ≥5% and at least twice that of placebo) include: somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased, constipation, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates…
Frequently Asked Questions
What is Alprazolam Extended Release used for?
Alprazolam Extended Release contains Alprazolam. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Alprazolam Extended Release a controlled substance?
Yes, Alprazolam Extended Release is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Alprazolam Extended Release?
The generic name for Alprazolam Extended Release is Alprazolam. There are 11 other brand versions of Alprazolam.
What is the NDC code for Alprazolam Extended Release .5 mg/1?
The NDC (National Drug Code) for Alprazolam Extended Release .5 mg/1 is 72162-1059, listed by Bryant Ranch Prepack.