XANAX XR- alprazolam tablet, extended release

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 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. XANAX XR is contraindicated in patients: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including XANAX XR, 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/. 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 pre

Product summary:

XANAX XR is supplied in the following strengths and package configurations: Bottles of 60 0.5 mg NDC 0009-0057-07 white, pentagonal shaped tablets debossed with an "X" on one side and "0.5" on the other side Bottles of 60 1 mg NDC 0009-0059-07 yellow, square shaped tablets debossed with an "X" on one side and "1" on the other side Bottles of 60 2 mg NDC 0009-0066-07 blue, round shaped tablets debossed with an "X" on one side and "2" on the other side Bottles of 60 3 mg NDC 0009-0068-07 green, triangular shaped tablets debossed with an "X" 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].

Authorization status:

New Drug Application

Patient Information leaflet

PHARMACIA & UPJOHN COMPANY LLC
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MEDICATION GUIDE
XANAX XR (ZAN-aks XR)
(alprazolam) extended-release tablets, C-IV
What is the most important information I should know about XANAX XR?
•
XANAX 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:
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 XR with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including XANAX XR 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 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.
o
You can develop an addiction even if you take XANAX XR as prescribed
by your healthcare
provider.
o
Take XANAX XR exactly as your healthcare provider prescribed.
o
Do not share your XANAX XR with other people.
o
Keep XANAX XR in a safe place and away from children.
•
Physical dependence and withdrawal reactions. XANAX XR can cause
physical dependence and
withdrawal reactions.
o
Do not suddenly stop taking XANAX XR. Stopping XANAX XR 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 extrem

Summary of Product characteristics

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