TEMAZEPAM- temazepam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam is 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 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 resulted in increasing nu

Product summary:

Product: 50436-4628 NDC: 50436-4628-2 30 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM - TEMAZEPAM CAPSULE
Unit Dose Services
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MEDGUIDE
MEDICATION GUIDE
Temazepam (tem az′ e pam) Capsules, USP CIV
What is the most important information I should know about temazepam
capsules?
•
Temazepam capsules are 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 temazepam capsules, 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
capsules. 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 temazepam capsules.
•
Do not take temazepam capsules 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 temazepam capsules than prescribed.
What are temazepam capsules?
•
Temazepam capsules are a prescription sleep medicine. Temazepam
capsules are 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 and waking up often during
the night.
•
Temazepam capsules are a federal controlled substance (CIV) because it
can be abused or lead to
dependence. Keep temazepam capsules in a safe place to prevent misuse
and abuse. Selling or
giving away temazepam capsules 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 temazepa

Summary of Product characteristics

TEMAZEPAM - TEMAZEPAM CAPSULE
UNIT DOSE SERVICES
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TEMAZEPAM CAPSULES, USP CIV
RX ONLY
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_ AND_ 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
Temazepam, USP 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, and the
structural formula is:
Temazepam, USP is a white, crystalline substance, very slightly
soluble in water and sparingly soluble
in alcohol, USP.
Temazepam capsules USP, 15 mg and 30 mg, are for oral administration.
_Active Ingredient:_ temazepam, USP
_Inactive Ingredients:_
Each capsule contains the following inactive ingredients: corn starch,
colloidal silicon dioxide,
gelatin, magnesium stearate, microcrystalline cellulose, silicon
dioxide, sodium lauryl sulfate, and
titanium dioxide. In addition, the 15 mg capsule also contains: D&C
yellow #10, FD&C green #3,
FD&C yellow #6 (Sunset Yellow). The imprinting ink, common for both
strengths, contains: black iron
oxide, D&C yellow #10 aluminum lake, FD&C blue#1 brilliant blue FCF
aluminum lake, FD&C blue #2
indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum
lake, shellac and may contain
propylene glycol.
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
p