TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

TRIAZOLAM

Composition:

TRIAZOLAM 0.25 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: - 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 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-

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: 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

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Triazolam
tablets, CIV
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised 2/2021
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:
•
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 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 as prescribed
by your healthcare
provider.
•
Take triazolam exactly as your healthcare provider prescribed.
•
Do not share your triazolam with other people.
•
Keep triazolam 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. 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 change

Summary of Product characteristics

TRIAZOLAM- TRIAZOLAM TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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_.
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
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
_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 presc