ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)

Available from:

Greenstone LLC

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam is indicated for the: Alprazolam is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Alprazolam 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 outcomes (see Data). The estimated background risk of major birth defects an

Product summary:

Alprazolam is supplied in the following strengths and package configurations: Bottles of 100 Bottles of 500 Bottles of 1000 0.25 mg NDC 59762-3719-1 NDC 59762-3719-3 NDC 59762-3719-4 white, oval, scored, imprinted "G3719" Bottles of 100 Bottles of 500 Bottles of 1000 0.5 mg NDC 59762-3720-1 NDC 59762-3720-3 NDC 59762-3720-4 peach, oval, scored, imprinted "G3720" Bottles of 100 Bottles of 500 Bottles of 1000 1 mg NDC 59762-3721-1 NDC 59762-3721-3 NDC 59762-3721-4 blue, oval, scored, imprinted "G3721" Bottles of 100 Bottles of 500 2 mg NDC 59762-3722-1 NDC 59762-3722-3 white, oblong, multi-scored, imprinted "G3722" Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Greenstone LLC
----------
MEDICATION GUIDE
alprazolam tablets, C-IV
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: February 2021
What is the most important information I should know about Alprazolam?
•
Alprazolam 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 with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including Alprazolam, 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. 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 as prescribed
by your healthcare
provider.
•
Take Alprazolam exactly as your healthcare provider prescribed.
•
Do not share your Alprazolam with other people.
•
Keep Alprazolam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Alprazolam can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking Alprazolam. Stopping Alprazolam suddenly
can cause serious
and life-threatening side effects, including, unusual movements,
responses, or expressions,
seizures, sudden and severe mental or nervous sy

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
GREENSTONE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPRAZOLAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALPRAZOLAM.
ALPRAZOLAM (ALPRAZOLAM) 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 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, EXPOSES USERS TO
RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
ALPRAZOLAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT'S RISK FOR
ABUSE, MISUSE,
AND ADDICTION. (5.2)
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM 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 OR REDUCE THE DOSAGE. (2.2, 5.3)
RECENT MAJOR CHANGES
Boxed Warning
2/2021
Dosage and Administration (2.3)
2/2021
Warnings and Precautions (5.2, 5.3)
2/2021
INDICATIONS AND USAGE
Alprazolam is a benzodiazepine indicated for the:
Acute treatment of generalized anxiety disorder in adults. (1)
Treatment of panic disorder with or without agoraphobia in adults. (1)
DOSAGE AND ADMINISTRATION
Generalized Anxiety Disorder: (2.1)
Recommended starting oral dosage is 0.25 mg to 0.5 mg three times
daily.
Dosage may be increased, at intervals of every 3 to 4 days, to a
maximum recommended daily
dose of 4 mg, given in divided doses.
Use the lowest possible effect