Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Greenstone LLC
ALPRAZOLAM
ALPRAZOLAM 0.5 mg
ORAL
PRESCRIPTION DRUG
Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam XR is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Alprazolam XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Other Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. Risk Summary Neonates born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and neonatal withdrawal [see Warnings and Precautions (5.4), Clinical Considerations]. Overall available data from published observational studies of pregnant women exposed to alprazolam have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal o
Alprazolam XR is supplied in the following strengths and package configurations: Bottles of 60 0.5 mg NDC 59762-0057-1 white, pentagonal shaped tablets debossed with an "G" on one side and "0.5" on the other side Bottles of 60 1 mg NDC 59762-0059-1 yellow, square shaped tablets debossed with an "G" on one side and "1" on the other side Bottles of 60 2 mg NDC 59762-0066-1 blue, round shaped tablets debossed with an "G" on one side and "2" on the other side Bottles of 60 3 mg NDC 59762-0068-1 green, triangular shaped tablets debossed with an "G" on one side and "3" on the other side Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
New Drug Application Authorized Generic
OLAM XR- ALPRAZOLAM TABLET, EXTENDED RELEASE Greenstone LLC ---------- MEDICATION GUIDE ALPRAZOLAM XR EXTENDED-RELEASE TABLETS, C-IV This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 3/2021 What is the most important information I should know about Alprazolam XR? • Alprazolam XR is 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 XR with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including Alprazolam XR 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 XR. 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 XR as prescribed by your healthcare provider. • Take Alprazolam XR exactly as your healthcare provider prescribed. • Do not share your Alprazolam XR with other people. • Keep Alprazolam XR in a safe place and away from children. • Physical dependence and withdrawal reactions. Alprazolam XR can cause physical dependence and withdrawal reactions. • Do not suddenly stop taking Alprazolam XR. Stopping Alprazolam XR suddenly can cause serious and life-threatening side effects, including, unu Прочитать полный документ
ALPRAZOLAM XR- ALPRAZOLAM TABLET, EXTENDED RELEASE GREENSTONE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALPRAZOLAM XR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALPRAZOLAM XR. ALPRAZOLAM XR 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 XR, EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE PRESCRIBING ALPRAZOLAM XR AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT'S RISK FOR ABUSE, MISUSE, AND ADDICTION. (5.2) ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM XR 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 XR OR REDUCE THE DOSAGE. (2.2, 5.3) RECENT MAJOR CHANGES Boxed Warning 2/2021 Dosage and Administration (2.2) 2/2021 Warnings and Precautions (5.2, 5.3) 2/2021 INDICATIONS AND USAGE Alprazolam XR is 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 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 da Прочитать полный документ