ALPRAZOLAM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

A-S Medication Solutions

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 alprazolam tablets 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 b

Produkto santrauka:

Product: 50090-5262 NDC: 50090-5262-1 90 TABLET in a BOTTLE

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

A-S Medication Solutions
----------
MEDICATION GUIDE
Alprazolam (al pra' zoe
lam)
Tablets, USP, C-IV
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 s

Prekės savybės

ALPRAZOLAM- ALPRAZOLAM TABLET
A-S MEDICATION SOLUTIONS
----------
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
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:
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,