TRIAZOLAM tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R)

थमां उपलब्ध:

A-S Medication Solutions

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam is contraindicated in: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to triazolam 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 Infants born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and neonatal withdrawal (see Clinical Considerations) [see Warnings and Precautions ( 5.10 )]. At this time, there is no clear evidence that triazolam exposure in early pregnancy can cause major birth defects (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population

उत्पाद समीक्षा:

Product: 50090-4733 NDC: 50090-4733-0 30 TABLET in a BOTTLE NDC: 50090-4733-1 100 TABLET in a BOTTLE

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

A-S Medication Solutions
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MEDICATION GUIDE
Triazolam Tablets, USP CIV
(trye az’ oh lam)
Rx only
What is the most important information I should know about Triazolam
Tablets?
•
Triazolam 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:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
triazolam tablets with opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including triazolam tablets which can lead to
overdose and serious side effects
including coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or misused
benzodiazepines, including triazolam 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.
o
You can develop an addiction even if you take triazolam tablets as
prescribed by your healthcare
provider.
o
Take triazolam tablets exactly as your healthcare provider prescribed.
o
Do not share your triazolam tablets with other people.
o
Keep triazolam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Triazolam tablets can
cause physical dependence and
withdrawal reactions.
o
Do not suddenly stop taking triazolam tablets. Stopping triazolam
tablets suddenly can cause serious
and life-threatening side effects, including unusual movements,
responses, or expressions, seizures,
sudden and severe mental or nervous system chan

उत्पाद विशेषताएं

TRIAZOLAM- TRIAZOLAM TABLET
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIAZOLAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIAZOLAM
TABLETS.
TRIAZOLAM TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1982
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
Triazolam is a benzodiazepine indicated for the short-term treatment
of insomnia (generally 7 to 10 days)
in adults. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT
PRESCRIBING OF
THESE DRUGS 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 TRIAZOLAM, EXPOSES USERS TO
RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
TRIAZOLAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE,
AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF TRIAZOLAM 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
TRIAZOLAM OR REDUCE THE DOSAGE (2.3, 5.3).
_Adults:_ Recommended dosage is 0.25 mg once daily before bedtime.
Maximum recommended
dosage is 0.5 mg once daily (2.1)
_Geriatric patients:_ Reduce starting dosage to 0.125 mg once daily.
May increase to 0.25 mg if