TEMAZEPAM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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/kg/da

Produkt oppsummering:

Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and  on the other side in red, and a blue cap imprinted “7.5 mg” twice in red.                   Bottle of 100 . . . . . . . . .NDC 0406-9960-01 Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and  on the other side in red, and an opaque blue cap imprinted “22.5 mg” twice in red.                   Bottle of 30 . . . . . . . . . .NDC 0406-9959-03 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 trademark of Hoffman-LaRoche Inc. **Trademark of Medical Economics Company, Inc. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo,   and other brands are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt. Rev 02/2017 MallinckrodtTM Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20T06.pdf or by calling 1-800-778-7898 for alternate delivery options.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Temazepam (te-maz'ĕ-pam) Capsules, C-IV
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:
o driving a car (“sleep-driving”)
o making and eating food
o talking on the phone
o having sex
o 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 (C-IV) 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 temazepam capsules are safe and effecti

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 Capsules USP are benzodiazepine hypnotic agents. 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 is a white, crystalline substance, very slightly soluble in
water and sparingly soluble in
alcohol USP.
Temazepam Capsules USP, 7.5 mg and 22.5 mg, are for oral
administration.
_7.5 MG AND 22.5 MG CAPSULES_
_Active Ingredient:_ temazepam USP
_7.5 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, iron oxide red, shellac, shellac
glaze, SD-35A alcohol.
_22.5 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF
Aluminum Lake, iron oxide red,
isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A
alcohol, SD-45 alcohol.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
H labeled drug, Restoril (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
d