Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Actavis Pharma, Inc.
ALPRAZOLAM
ALPRAZOLAM 0.5 mg
ORAL
PRESCRIPTION DRUG
Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. 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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines lat
Alprazolam extended-release tablets, USP are available as follows: 0.5 mg : Each white to off-white, round tablet imprinted with on one side and 83 on the other contains 0.5 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3083-06). 1 mg : Each yellow, round tablet imprinted with on one side and 84 on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3084-06). 2 mg : Each peach, round tablet imprinted with on one side and 87 on the other contains 2 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3087-06). 3 mg : Each light green, round tablet imprinted with on one side and 86 on the other contains 3 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3086-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
Actavis Pharma, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.tevausa.com/medguides Alprazolam (al pra' zoe lam) Extended-Release Tablets, C-IV What is the most important information I should know about alprazolam extended-release tablets? • Alprazolam extended-release tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: • shallow or slowed breathing • breathing stops (which may lead to the heart stopping) • excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking alprazolam extended-release tablets with opioids affect you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including alprazolam extended-release tablets which can lead to overdose and serious side effects including coma and death. • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including alprazolam extended-release tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. • You can develop an addiction even if you take alprazolam extended-release tablets as prescribed by your healthcare provider. • Take alprazolam extended-release tablets exactly as your healthcare provider prescribed. • Do not share your alprazolam extended-release tablets with other people. • Keep alprazolam extended-release tablets in a safe place and away from children. • Physical dependence and withdrawal reactions. Alprazolam extended-release tablets can cause physical dependence an Lestu allt skjalið
ALPRAZOLAM EXTENDED RELEASE- ALPRAZOLAM TABLET, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALPRAZOLAM EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM EXTENDED-RELEASE TABLETS, FOR ORAL USE, CIV INITIAL U.S. APPROVAL: 1981 WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. (5.1, 7.1) THE USE OF BENZODIAZEPINES, INCLUDING ALPRAZOLAM EXTENDED-RELEASE TABLETS, EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE PRESCRIBING ALPRAZOLAM EXTENDED-RELEASE TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. (5.2) ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM EXTENDED-RELEASE TABLETS AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE ALPRAZOLAM EXTENDED-RELEASE TABLETS OR REDUCE THE DOSAGE. (2.2, 5.3) RECENT MAJOR CHANGES Warnings and Precautions (5.8) 1/2023 INDICATIONS AND USAGE Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. (1) 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 Lestu allt skjalið