TEMAZEPAM capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

DirectRX

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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-postna

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

DirectRX
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Revised: 6/2020
Document Id: a8261a8c-cf26-d681-e053-2995a90a60ab
34391-3
Set id: 09e74fd3-223b-4476-86b3-f5eeeb5af330
Version: 3
Effective Time: 20200615
DirectRX

Caracteristicilor produsului

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