ALPRAZOLAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

ALPRAZOLAM

Komposisi:

ALPRAZOLAM 2 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Alprazolam tablets are indicated for the: - acute treatment of generalized anxiety disorder (GAD) in adults. - treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam is contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions ( 6.2)] . - taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration ( 2.6), Warnings and Precautions ( 5.5), Drug Interactions ( 7.1)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam, 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/pregnancyregistr

Ringkasan produk:

Alprazolam tablets, USP for oral administration are in the following strengths and package configurations: Rectangular white multi-scored tablets debossed “GG 249” on one side and plain on the reverse side and supplied as: NDC 55289-523-30 Bottles of 30 NDC 55289-523-40 Bottles of 40 NDC 55289-523-60 Bottles of 60 NDC 55289-523-90 Bottles of 90 NDC 55289-523-01 Bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP OUT OF THE REACH OF CHILDREN.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
ALPRAZOLAM TABLETS, USP CIV
(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

Ciri produk

ALPRAZOLAM- ALPRAZOLAM TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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._
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)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.8) 1/2023
INDICATIONS AND USAGE
Alprazolam tablets are 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 effec