ALPRAZOLAM 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:

Greenstone LLC

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

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

Summary of Product characteristics

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