XANAX- alprazolam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PHARMACIA & UPJOHN COMPANY LLC

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XANAX is indicated for the: XANAX is contraindicated in patients: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including XANAX, 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/research/pregnancyregistry/. Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) and Clinical Considerations)] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adve

Product summary:

XANAX is supplied in the following strengths and package configurations: Package Configuration Tablet Strength (mg) NDC Print Bottles of 100 Reverse Numbered Unit dose (100) Bottles of 500 Bottles of 1000 0.25 mg NDC 0009-0029-01 NDC 0009-0029-46 NDC 0009-0029-02 NDC 0009-0029-14 white, oval, scored, imprinted “XANAX 0.25” Bottles of 100 Reverse Numbered Unit dose (100) Bottles of 500 Bottles of 1000 0.5 mg NDC 0009-0055-01 NDC 0009-0055-46 NDC 0009-0055-03 NDC 0009-0055-15 peach, oval, scored, imprinted “XANAX 0.5” Bottles of 100 Bottles of 500 Bottles of 1000 1 mg NDC 0009-0090-01 NDC 0009-0090-04 NDC 0009-0090-13 blue, oval, scored, imprinted “XANAX 1.0” Bottles of 100 Bottles of 500 2 mg NDC 0009-0094-01 NDC 0009-0094-03 white, oblong, multi-scored, imprinted “XANAX” on one side and “2” on the reverse side   Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

PHARMACIA & UPJOHN COMPANY LLC
----------
MEDICATION GUIDE
XANAX (ZAN-aks)
(alprazolam) tablets, C-IV
What is the most important information I should know about XANAX?
•
XANAX 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:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
XANAX with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including XANAX, which can lead to overdose and
serious side effects including
coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including XANAX. 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.
o
You can develop an addiction even if you take XANAX as prescribed by
your healthcare
provider.
o
Take XANAX exactly as your healthcare provider prescribed.
o
Do not share your XANAX with other people.
o
Keep XANAX in a safe place and away from children.
•
Physical dependence and withdrawal reactions. XANAX can cause physical
dependence and
withdrawal reactions.
o
Do not suddenly stop taking XANAX. Stopping XANAX suddenly can cause
serious and life-
threatening side effects, including, unusual movements, responses, or
expressions, seizures,
sudden and severe mental or nervous system changes, depression, seeing
or hearing things that
others do not see or hear, an extreme increase in activity or talking,
losing touch with rea

Summary of Product characteristics

XANAX- ALPRAZOLAM TABLET
PHARMACIA & UPJOHN COMPANY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XANAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XANAX.
XANAX (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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 1/2023
INDICATIONS AND USAGE
XANAX is a benzodiazepine indicated for the:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, and 2 mg (3)
CONTRAINDICATIONS
•
•
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 XANAX, EXPOSES USERS TO RISKS OF
ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
XANAX AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE,
AND ADDICTION. (5.2)
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF XANAX 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 XANAX
OR REDUCE THE DOSAGE. (2.2, 5.3)
Acute treatment of generalized anxiety disorder in adults. (1)
Treatment of panic disorder with or without agoraphobia in adults. (1)
Generalized Anxiety Disorder: (2.1)
o
o
o
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