ALPRAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam tablets are 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 d

Product summary:

Product: 50090-2781 NDC: 50090-2781-0 30 TABLET in a BOTTLE NDC: 50090-2781-1 20 TABLET in a BOTTLE NDC: 50090-2781-3 90 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

A-S Medication Solutions
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MEDICATION GUIDE
Alprazolam Tablets, USP C-IV
(al PRAY zoe lam)
What is the most important information I should know about alprazolam
tablets?
•
Alprazolam tablets are 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 tablets with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including alprazolam tablets, 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 tablets. 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 tablets as
prescribed by your healthcare
provider.
○
Take alprazolam tablets exactly as your healthcare provider
prescribed.
○
Do not share your alprazolam tablets with other people.
○
Keep alprazolam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Alprazolam tablets can
cause physical dependence and
withdrawal reactions.
○
Do not suddenly stop taking alprazolam tablets. Stopping alprazolam
tablets suddenly can cause
serious and life-threatening side effects, including, unusual
movements, responses, or expressions,
seizures, sudden and sev

Summary of Product characteristics

ALPRAZOLAM- ALPRAZOLAM TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPRAZOLAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ALPRAZOLAM TABLETS.
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
Boxed Warning 2/2021
Dosage and Administration (2.3) 2/2021
Warnings and Precautions (5.2, 5.3) 2/2021
INDICATIONS AND USAGE
Alprazolam tablets are a benzodiazepine indicated for the:
•
•
DOSAGE AND ADMINISTRATION
•
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○
○
•
•
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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 ALPRAZOLAM TABLETS, EXPOSES
USERS TO RISKS
OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH.
BEFORE
PRESCRIBING ALPRAZOLAM TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH
PATIENT’S
RISK FOR ABUSE, MISUSE, AND ADDICTION. (5.2)
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM TABLETS
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 TABLETS 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)
Recommended starting oral dos