TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

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 7–10 days). Use for more than 2–3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7–10 days) and it should not be prescribed in quantities exceeding a 1-month supply. Triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Triazolam is contraindicated in pregnant women. If there is a likelihood of the patient becoming pregnant while receiving triazolam, she should

Product summary:

Product: 50436-3718 NDC: 50436-3718-1 30 TABLET in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

TRIAZOLAM- TRIAZOLAM TABLET
Unit Dose Services
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MEDICATION GUIDE
TRIAZOLAM TABLETS, C-IV
Rx only
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 depressants
(including street drugs)
can cause severe drowsiness, breathing problems (respiratory
depression), coma and
death.
•
After taking triazolam, you may get up out of bed while not being
fully awake and do
an activity that you do not know you are doing. The next morning, you
may not
remember that you did anything during the night. You have a higher
chance for doing
these activities if you drink alcohol or take other medicines that
make you sleepy with
triazolam. Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the
above activities after taking triazolam.
•
Do not take triazolam unless you are able to stay in bed a full night
(7 to 8 hours)
before you must be active again.
•
Do not take more triazolam than prescribed.
What is triazolam?
•
Triazolam is a prescription medicine used to treat certain types of
insomnia including
difficulty falling asleep, waking up often during the night, or waking
up early in the
morning.
•
Triazolam is a federal controlled substance (C-IV) because it can be
abused or lead to
dependence. Keep triazolam in a safe place to prevent misuse and
abuse. Selling or
giving away triazolam may harm others, and is against the law. Tell
your healthcare
provider if you have ever abused or been dependent on alcohol,
prescription medicines
or street drugs.
•
It is not known if triazolam is safe and effective in children.
•
Elderly patients are especially susceptible to dose related adverse
effects when taking
triazolam.
•
It is not known if triazolam is safe and effective for use longer than
2

Summary of Product characteristics

TRIAZOLAM- TRIAZOLAM TABLET
UNIT DOSE SERVICES
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TRIAZOLAM TABLETS, USP CIV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death _[_see _Warnings, Drug Interactions]_.
Reserve concomitant prescribing of these drugs for use 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.
DESCRIPTION
Triazolam is a triazolobenzodiazepine hypnotic agent.
Triazolam is a white crystalline powder, soluble in alcohol and poorly
soluble in water. It has a
molecular weight of 343.21.
The chemical name for triazolam is
8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α] [1,4]
benzodiazepine.
The structural formula is represented below:
Each triazolam tablet, for oral administration, contains 0.125 mg or
0.25 mg of triazolam. Inactive
ingredients: 0.125 MG—cellulose, corn starch, docusate sodium,
lactose, magnesium stearate, silicon
dioxide, sodium benzoate; 0.25 MG—cellulose, corn starch, docusate
sodium, FD&C Blue No. 2,
lactose, magnesium stearate, silicon dioxide, sodium benzoate.
CLINICAL PHARMACOLOGY
Triazolam is a hypnotic with a short mean plasma half-life reported to
be in the range of 1.5 to 5.5
hours. In normal subjects treated for 7 days with four times the
recommended dosage, there was no
evidence of altered systemic bioavailability, rate of elimination, or
accumulation. Peak plasma levels
are reached within 2 hours following oral administration. Following
recommended doses of triazolam
tablets, triazolam peak plasma levels in the range of 1 to 6 ng/mL are
seen. The plasma levels achieved
are proportional to the dose given.
Triazolam and its metabolites, principally as conjugated glucuronides,
which are presumably inactive,
are excreted primarily in the urine. Only small amounts of
unmetabolized triazolam appear in the urine.
The two primary met