ALPRAZOLAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 tablets are 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 1-866-961-238

產品總結:

Alprazolam Tablets USP are supplied in the following strengths and package configurations: Alprazolam Tablets USP, 1 mg are blue colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘2’ and ‘0’ on either sides of the breakline and ‘Y’ on the other side. NDC: 70518-3730-00 PACKAGING: 60 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

授权状态:

Abbreviated New Drug Application

资料单张

REMEDYREPACK INC.
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MEDICATION GUIDE
Alprazolam Tablets, USP C-IV
(al pra' 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 severe men

产品特点

ALPRAZOLAM- ALPRAZOLAM TABLET
REMEDYREPACK INC.
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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._
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, EXPOSES USERS TO
RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
ALPRAZOLAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE,
AND ADDICTION. ( 5.2) ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM 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 OR REDUCE THE DOSAGE. ( 2.2, 5.3)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.8) 1/2023
INDICATIONS AND USAGE
Alprazolam is 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 effective dose and frequently assess the need
for contin