TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

INN (International Name):

TRIAZOLAM

Composition:

TRIAZOLAM 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10) and Clinical Considerations] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data ). The background risk of major birth defects and miscarriage for the indic

Product summary:

Triazolam is supplied as a 0.125 mg white tablet or a 0.25 mg powder blue, scored tablet in the following strengths and package configurations: Bottles of 10 0.125 mg NDC 59762-3717-4 G3717 Bottles of 100 0.125 mg NDC 59762-3717-9 G3717 Bottles of 10 0.25 mg NDC 59762-3718-4 G3718 Bottles of 100 0.25 mg NDC 59762-3718-9 G3718 Bottles of 500 0.25 mg NDC 59762-3718-3 G3718 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Greenstone LLC
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MEDICATION GUIDE
TRIAZOLAM
TABLETS, CIV
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 6/2023
What is the most important information I should know about triazolam?
•
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 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.
o
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.
o
You can develop an addiction even if you take triazolam as prescribed
by your healthcare
provider.
o
Take triazolam exactly as your healthcare provider prescribed.
o
Do not share your triazolam with other people.
o
Keep triazolam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Triazolam can cause
physical dependence and
withdrawal reactions.
o
Do not suddenly stop taking triazolam. Stopping triazolam suddenly can
cause serious and
life-threatening side effects, including unusual movements, responses,
or expressions,
seizures, sudden and severe mental or nervous system changes,
depression, seeing or hearin

Summary of Product characteristics

TRIAZOLAM- TRIAZOLAM TABLET
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIAZOLAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIAZOLAM.
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
Warnings and Precautions (5.10)
2/2023
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
•
•
•
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 no
response. Geriatric patients should not exceed 0.25 mg once daily
(2.2, 8.5)
Tri