TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

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:

Triazolam tablets are available in the following strengths and package sizes: 0.125 mg (white,, imprinted G3717): 10–10 Tablet Bottles                            NDC 59762-3717-4 0.25 mg (powder blue, scored, imprinted G3718): 10–10 Tablet Bottles                            NDC 59762-3718-4 Bottles of 500                                       NDC 59762-3718-3 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

TRIAZOLAM - TRIAZOLAM TABLET
STAT RX USA LLC
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MEDICATION GUIDE
TRIAZOLAM Tablets/ C-IV
Read this Medication Guide before you start taking triazolam and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your doctor about your
medical condition or treatment. You and your doctor should talk about
the SEDATIVE-HYPNOTIC
when you start taking it and at regular checkups.
What is the most important information I should know about triazolam?
After taking a SEDATIVE-HYPNOTIC, 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 a SEDATIVE-HYPNOTIC.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1.
Take triazolam exactly as prescribed
•
Do not take more triazolam than prescribed.
•
Take triazolam right before you get in bed, not sooner.
2.
Do not take triazolam if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your
medicines. Your doctor will tell you if you can take triazolam with
your other medicines
•
cannot get a full night's sleep
•
are pregnant or considering becoming pregnant
3.
Call your doctor right away if you find out that you have done any of
the above activities after
taking triazolam.
What are SEDATIVE-HYPNOTICS?
SEDATIVE-HYPNOTICs are sleep medicines. SEDATIVE-HYPNOTICS are used in
adults for the
treatment of the symptom of trouble falling asleep due to insomnia.
Triazolam is not indicated for use in children.
Elderly patients are especially susceptible to dose related adverse
effects when taking triazolam.
Triazolam is a federally controlled substance (C-IV) because it can be
abused or lead to depend

Summary of Product characteristics

TRIAZOLAM - TRIAZOLAM TABLET
STAT RX USA LLC
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TRIAZOLAM TABLETS, USP CIV
CIV
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 metabolites accounted for 79.9% of urinary excretion.
Urinary excretion appeared to
be biphasic in its time course.
Triazolam tablets 0.5 mg, in two separate studies, did not affect the
prothrombin times or plasma
warfarin levels in male volunteers administered sodium warfarin
orally.
Extremely high concentrations of triazolam do not displace bilirubin
bound to human serum albumin _in_
_vitro_.
Triazolam
C was administered orally to pregnant mice. Drug-relate