TEMAZEPAM- temazepam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. Benzodiazepines may cause fetal harm when administered to a pregnant woman. 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. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day result

Product summary:

Temazepam Capsules, USP are available containing 7.5 mg, 15 mg, 22.5 mg or 30 mg of temazepam, USP. The 7.5 mg capsule is a hard-shell gelatin capsule with a peach opaque cap and an ivory opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 3110 in black ink on both the cap and the body. They are available as follows: NDC 0378-3110-93 bottles of 30 capsules NDC 0378-3110-01 bottles of 100 capsules NDC 0378-3110-05 bottles of 500 capsules The 15 mg capsule is a hard-shell gelatin capsule with a peach opaque cap and a peach opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 4010 in black ink on both the cap and the body. They are available as follows: NDC 0378-4010-77 bottles of 90 capsules NDC 0378-4010-01 bottles of 100 capsules NDC 0378-4010-05 bottles of 500 capsules The 22.5 mg capsule is a hard-shell gelatin capsule with a yellow opaque cap and a peach opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 3120 in black ink on both the cap and the body. They are available as follows: NDC 0378-3120-93 bottles of 30 capsules NDC 0378-3120-01 bottles of 100 capsules NDC 0378-3120-05 bottles of 500 capsules The 30 mg capsule is a hard-shell gelatin capsule with a yellow opaque cap and a yellow opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 5050 in black ink on both the cap and the body. They are available as follows: NDC 0378-5050-77 bottles of 90 capsules NDC 0378-5050-01 bottles of 100 capsules NDC 0378-5050-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- TEMAZEPAM CAPSULE
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
----------
MEDICATION GUIDE FOR TEMAZEPAM
CAPSULES, USP
Read the Medication Guide that comes with temazepam before you start
taking it 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.
What is the most important information I should know about temazepam?
After taking temazepam, 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 temazepam. Reported activities include:
•
driving a car (“sleep-driving”)
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your doctor right away if you find out that you have done any of
the above activities after taking
temazepam.
Important:
1.
Take temazepam exactly as prescribed
▪ Do not take more temazepam than prescribed.
▪ Take temazepam right before you get in bed, not sooner.
2.
Do not take temazepam 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 temazepam with
your other medicines
▪ cannot get a full night’s sleep
What is temazepam?
Temazepam is a sedative-hypnotic (sleep) medicine. Temazepam is used
in adults for the short-term
(usually 7 to 10 days) treatment of a sleep problem called insomnia.
Symptoms of insomnia include:
•
trouble falling asleep
•
waking up often during the night
Temazepam is not for children.
Temazepam is a federally controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep temazepam in a safe place to prevent misuse and abuse. Selling or
giving away temazepam may
harm others, and is a

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro-1,3-dihydro-3-hydroxy-
1-methyl-5-phenyl-2_H_-1,4-benzodiazepin-2-one. Its structural formula
may be represented as follows:
C H CLN O
M.W. = 300.74
Temazepam, USP is a white, crystalline substance, very slightly
soluble in water and sparingly soluble
in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg,
are for oral administration.
Each capsule contains the following inactive ingredients: colloidal
silicon dioxide, magnesium stearate,
microcrystalline cellulose, powdered cellulose and sodium lauryl
sulfate. The empty gelatin capsule
shell for all strengths contains FD&C Yellow No. 6, gelatin and
titanium dioxide. In addition, the 7.5
mg, 22.5 mg and 30 mg empty gelatin capsules contain D&C Yellow No.
10. The imprinting ink contains
black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1
Aluminum Lake, FD&C Blue
No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol
and shellac glaze.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
H labeled drug, temazepam was well absorbed and found to have minimal
(8%) first pass metabolism.
There were no active metabolites formed and the only significant
metabolite present in blood was the
O-conjugate. The unchanged drug was 96% bound to plasma proteins. The
blood level decline of the
parent drug was biphasic with the short half-life ranging from 0.4 to
0.6 hours and the terminal half-life
from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study
population and method of determination.
Metabolites were formed with a half-life of 10 hours and excreted with
a half-life of approximately 2
hours. Thus, formation of the major metabolite is the rate limiting
step in the biodisposition of
temazepam. There is no accumulation of metabolites. A dose
proporti