TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triazolam tablets are 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, 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/pregnancyregistry/. Risk Summ

Product summary:

Triazolam Tablets USP, 0.125 mg are white to off-white, elliptical tablet, plain on one side and debossed with "1521" on other side of tablet and are supplied as follows: NDC 70710-1521-8 in bottles of 10 tablets with child-resistant closure NDC 70710-1521-1 in bottles of 100 tablets with child-resistant closure NDC 70710-1521-5 in bottles of 500 tablets Triazolam Tablets USP, 0.25 mg are light-grayish blue, elliptical, mottled, scored tablet, plain on one side and debossed with "12" and "89" on either side of scoreline and are supplied as follows: NDC 70710-1289-8 in bottles of 10 tablets with child-resistant closure NDC 70710-1289-1 in bottles of 100 tablets with child-resistant closure NDC 70710-1289-5 in bottles of 500 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Triazolam (trye az' oh lam) Tablets USP, CIV
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 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
changes,

Summary of Product characteristics

TRIAZOLAM - TRIAZOLAM TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
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 tablets are 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 should not be prescribed in quantities exceeding a 1-month
suppl