TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

temazepam (UNII: CHB1QD2QSS) (temazepam - UNII:CHB1QD2QSS)

Available from:

Rebel Distributors Corp

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam Capsules, USP 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 perinatalpostnatal study in rats, oral doses of 60 mg/kg/day re

Product summary:

Temazepam Capsules USP 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 100........NDC 67877-147-01 Bottle of 500........NDC 67877-147-05 Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Romazicon is the registered trademark of Hoffman-LaRoche Inc. **Trademark of Medical Economics Company, Inc. Manufactured by:                                          Distributed by: Novel Laboratories, Inc.                                 ASCEND Laboratories, LLC Somerset, NJ 08873                                      Montvale, NJ 07645 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Rebel Distributors Corp
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MEDICATION GUIDE
TEMAZEPAM Capsules, USP C-IV
(temazepam)
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 m

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
REBEL DISTRIBUTORS CORP
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TEMAZEPAM
RX ONLY
Enter section text here
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro 1,3-dihydro-3-
hydroxyl-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the
structural formula is:
C
H
ClN
O
MW = 300.74
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly soluble in
alcohol USP.
Temazepam capsules, 15 mg and 30 mg, are for oral administration.
16
13
2
2
_15 MG AND 30 MG CAPSULES_
Active Ingredient: temazepam USP
_15 MG CAPSULES_
_Inactive Ingredients:_
Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C
yellow # 5, FD&C yellow # 6, gelatin and titanium dioxide.
_May also include:_
benzyl alcohol, butylparaben, sodium lauryl sulfate, edetate calcium
disodium, methylparaben, propyl
paraben and sodium propionate. Imprinting ink may contain ammonium
hydroxide, ethanol, 2-propanol,
butanol, pharmaceutical shellac, potassium hydroxide, propylene
glycol, black iron oxide, and other
ingredents.
_30 MG CAPSULES_
_Inactive Ingredients:_
Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl
sulfate, gelatin and titanium dioxide.
_May also include:_
benzyl alcohol, butylparaben, sodium lauryl sulfate, edetate calcium
disodium, methylparaben, propyl
paraben and sodium propionate. Imprinting ink may contain ammonium
hydroxide, ethanol, 2-propanol,
butanol, pharmaceutical shellac, potassium hydroxide, propylene
glycol, black iron oxide, and other
ingredents.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
3H 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 h