TEMAZEPAM capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aphena Pharma Solutions - Tennessee, LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 perinatal-postnatal study in rats, oral doses of 60 mg/kg/day r

Tuoteyhteenveto:

Temazepam Capsules USP   7.5 mg Pink opaque cap and white opaque body, imprinted “7.5 mg” on cap and “Novel 120” on the body in black ink. Bottle of 30         NDC 67877-148-30 Bottle of 100       NDC 67877-148-01 Bottle of 500       NDC 67877-148-05   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 100       NDC 67877-146-01 Bottle of 500       NDC 67877-146-05   22.5 mg Light blue opaque cap and white opaque body, imprinted “22.5 mg” on cap and “Novel 122” on the body in black ink. Bottle of 30         NDC 67877-149-30 Bottle of 100       NDC 67877-149-01 Bottle of 500       NDC 67877-149-05   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. 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 Parsippany, NJ 07054

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

TEMAZEPAM - TEMAZEPAM CAPSULE
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
TEMAZEPAM Capsules, USP CIV
(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 you

Valmisteyhteenveto

TEMAZEPAM - TEMAZEPAM CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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RX ONLY
DESCRIPTION
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:
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, 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.
16
13
2
2
_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
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