TRIAZOLAM tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

PD-Rx Pharmaceuticals, Inc.

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: - Patients with known hypersensitivity to triazolam, any of component of triazolam tablets, or other benzodiazepines. Reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. - Concomitant administration of strong cytochrome P450 (CYP 3A) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [ see Warnings and Precautions ( 5.8 ), Drug Interactions ( 7.1) ] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, 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/pre

उत्पाद समीक्षा:

Triazolam Tablets, USP are available in the following strength and package size: 0.25 mg tablets are supplied as a blue colored, elliptical shaped tablets with “ING646” debossed on one side and scored on other side: NDC 72789-349-30: Bottles of 30 Store at controlled room temperature 20° to 25°C (68° to 77°F) [ see USP Controlled Room Temperature ] .

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

PD-Rx Pharmaceuticals, Inc.
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Dispense with Medication Guide available at:
www.ingenus.com/medguide/triazolam-tablets.pdf
MEDICATION GUIDE
TRIAZOLAM TABLETS USP CIV (TRYE AZ’ OH LAM)
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 01/2023
What is the most important information I should know about Triazolam
Tablets?
•
Triazolam 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
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 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 triazolam.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 triazolam tablets as
prescribed by your
healthcare provider.
•
Take triazolam tablets exactly as your healthcare provider prescribed.
•
Do not share your triazolam tablets with other people.
•
Keep triazolam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Triazolam can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking triazolam tablets.Stopping triazola

उत्पाद विशेषताएं

TRIAZOLAM- TRIAZOLAM TABLET
PD-RX PHARMACEUTICALS, INC.
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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._
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).
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.10) 1/2023
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
_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 no
response. Geriatric patients should not exceed 0.25 mg once daily (
2.2, 8.5)
Triazolam tablets should not be prescribed in quantities exceeding a
1-month su