STRAZEPAM- temazepam, choline kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physician Therapeutics LLC

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 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. CONTRAINDICATIONS 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 stud

Product summary:

HOW SUPPLIED Temazepam Capsules USP 15 mg Green opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 100........NDC 67877-146-01 Bottle of 500........NDC 67877-146-05 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. *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 How Supplied Sentra PM is supplied in red and white, size 0 capsules in bottles of 60 capsules. Physician Supervision Sentra PM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.  Sentra PM is supplied to physicians in a recyclable plastic bottle with a child-resistant cap. U.S. patents pending. Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225  Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com © Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved NDC # 68405-1003-02

Authorization status:

unapproved drug other

Patient Information leaflet

STRAZEPAM - TEMAZEPAM, CHOLINE
Physician Therapeutics LLC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
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 asle

Summary of Product characteristics

STRAZEPAM - TEMAZEPAM, CHOLINE
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
STRAZEPAM
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:
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. 15 mg and 30 mg
Capsules Active Ingredient: temazepam USP 15 mg Capsules Inactive
Ingredients: Corn starch, lactose
anhydrous, magnesium stearate, sodium lauryl sulfate, FDandC Blue #1,
FDandC yellow # 5, FDandC
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.
Structural Formula
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