TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

temazepam

Composition:

temazepam 15 mg

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, USP 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/

Product summary:

Temazepam Capsules USP 15 mg Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 30........NDC 63187-132-30 Bottle of 60........NDC 63187-132-60 Bottle of 90........NDC 63187-132-90 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: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: ASCEND Laboratories, LLC Montvale, NJ 07645 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Proficient Rx LP
Reference Label Set Id: 2836b4f8-8667-4b49-9130-9c47e0614da6
Reference Label Set Id: cff2d112-a712-4ed1-bb45-5ddf3faedfdf
Reference Label Set Id: efe75381-d27f-49dc-9d25-6f4154c86b7d
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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.

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
PROFICIENT RX LP
REFERENCE LABEL SET ID: 2836B4F8-8667-4B49-9130-9C47E0614DA6
REFERENCE LABEL SET ID: CFF2D112-A712-4ED1-BB45-5DDF3FAEDFDF
REFERENCE LABEL SET ID: EFE75381-D27F-49DC-9D25-6F4154C86B7D
----------
RX ONLY
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, and
the structural
formula is:
C
H
CIN O MW =
300.74
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly
soluble in alcohol USP.
Temazepam Capsules, USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for
oral
administration.
_7.5 MG, 15 MG, 22.5 MG AND 30 MG CAPSULES_
Active Ingredient: temazepam USP
_7.5 MG CAPSULES_
_Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Red #40 and titanium dioxide.
_May also include:_ sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium
hydroxide, propylene
glycol, and black iron oxide.
_15 MG CAPSULES_
_Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide.
_May also include:_ sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium
hydroxide, propylene
16
13
2
2
glycol, and black iron oxide.
_22.5 MG CAPSULES_
_Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.
_May also include:_ sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium
hydroxide, propylene
glycol, and black iron oxide.
_30 MG CAPSULES_
_Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, gelatin and titanium dioxide.
_May also include:_ sodium lauryl sulfate. Imprinting ink