TRIAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, Inc.

INN (International Name):

TRIAZOLAM

Composition:

TRIAZOLAM 0.25 mg

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). Use for more than 2 to 3 weeks requires complete reevaluation of the patient (see WARNINGS). Prescriptions for triazolam should be written for short-term use (7 to 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 Tablets are contraindicated in pregnant women. If there is a likelihood of the patient becoming pregnant while recei

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 0.125 mg white, unscored, oval-shaped tablets (Identified 54 519). NDC 0054-4858-51: Bottles of 10 tablets. NDC 0054-8858-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. 0.25 mg blue, scored, oval-shaped tablets (Identified 54 620). NDC 0054-4859-29: Bottles of 500 tablets. NDC 0054-4859-51: Bottles of 10 tablets. NDC 0054-8859-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container, as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRIAZOLAM- TRIAZOLAM TABLET
Aphena Pharma Solutions - Tennessee, Inc.
----------
MEDICATION GUIDE
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
beingfully 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 aboveactivities 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
depen

Summary of Product characteristics

TRIAZOLAM- TRIAZOLAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
TRIAZOLAM TABLETS, USP 0.25 MG CIV
Rx only
DESCRIPTION
Triazolam tablets contain triazolam, 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-4_H_-_s_-triazolo-[4,3-
α][1,4]benzodiazepine..
The structural formula is represented below:
C H CL
N
Each triazolam tablet, for oral administration, contains 0.125 mg or
0.25 mg of triazolam. Inactive
ingredients: 0.125 MG-corn starch, docusate sodium, lactose
(anhydrous), magnesium stearate,
microcrystalline cellulose; 0.25 MG-corn starch, docusate sodium, FD&C
Blue No. 1, lactose
(anhydrous), magnesium stearate, microcrystalline cellulose.
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, 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_.
17
12
2
4
14
Triazolam
C w