TEMAZEPAM capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

DirectRX

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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/

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

DirectRX
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SPL MEDGUIDE SECTION
•
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 misuse and
abuse. Selling or giving
away TEMAZEPAM may harm others, and is against the law. Tell your
doctor if you have ever
abused or been

Produktens egenskaper

TEMAZEPAM- TEMAZEPAM CAPSULE
DIRECTRX
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TEMAZEPAM
DESCRIPTION SECTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro-1,3-dihydro-3-
hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the
structural formula is:
C16H13CIN2O2 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.
sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide,
ethanol, isopropyl alcohol,
butanol, shellac, potassium hydroxide, propylene glycol, and black
iron oxide.May also include:
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
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 may contain
ammonium hydroxide, ethanol,
isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene
glycol, and black iron oxide.
CLINICAL PHARMACOLOGY SECTION
Pharmacokinetics
In a single and multiple dose