FLURAZEPAM HYDROCHLORIDE capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

FLURAZEPAM HYDROCHLORIDE (UNII: 756RDM536M) (FLURAZEPAM - UNII:IHP475989U)

Доступна с:

Physicians Total Care, Inc.

ИНН (Международная Имя):

FLURAZEPAM HYDROCHLORIDE

состав:

FLURAZEPAM HYDROCHLORIDE 15 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Flurazepam hydrochloride is a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam hydrochloride capsules can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that flurazepam hydrochloride capsules are effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient. Flurazepam hydrochloride capsules are contraindicated in patients with known hypersensitivity to the drug. Usage in Pregnancy Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malfo

Обзор продуктов:

Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of flurazepam hydrochloride, USP. The 15 mg capsule is a hard-shell gelatin capsule with a white opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with MYLAN over 4415 in black ink on both the cap and body. They are available as follows: The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with MYLAN over 4430 in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

FLURAZEPAM HYDROCHLORIDE - FLURAZEPAM HYDROCHLORIDE CAPSULE
Physicians Total Care, Inc.
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MEDICATION GUIDE FLURAZEPAM
HYDROCHLORIDE CAPSULES, USP
Flurazepam Hydrochloride Capsules USP, 15 mg and 30 mg are a
Sedative-Hypnotic Indicated for
Insomnia
Read this Medication Guide carefully before you start taking your
medicine and each time you get more,
since there may be new information. It does not contain all the
information about your medicine that you
may need to know, so please ask your doctor, nurse or pharmacist if
you have any questions.
IMPORTANT
YOUR DOCTOR HAS PRESCRIBED THIS DRUG FOR YOUR USE ONLY. DO NOT LET
ANYONE ELSE USE IT. KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN
AND
PETS. If a child puts a flurazepam hydrochloride capsule in his or her
mouth or swallows it, call your
local Poison Control Center or go immediately to the nearest emergency
room.
What is the most important information I should know about
sedative-hypnotic drugs?
After taking a sedative-hypnotic drug, 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 medications that make you sleepy with a sedative-hypnotic drug.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1.
Take a sedative-hypnotic drug exactly as prescribed:
•
Do not take more sedative-hypnotic drugs than prescribed.
•
Take the sedative-hypnotic drug right before you get in bed, not
sooner.
2.
Do not take a sedative-hypnotic drug 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 a
sedative-hypnotic drug with your
other medicines
•
cannot get a full night sleep
3.
Call your doctor right away if you find out that

Характеристики продукта

FLURAZEPAM HYDROCHLORIDE - FLURAZEPAM HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Flurazepam hydrochloride is chemically
7-chloro-1-[2-(diethylamino)ethyl]-5-(_o_-fluoro-phenyl)-
1,3dihydro-2_H_-1,4-benzodiazepin-2-one dihydrochloride. It is a pale
yellow, crystalline compound,
freely soluble in alcohol and very soluble in water. It has a
molecular weight of 460.81 and the
following structural formula:
Each capsule for oral administration contains either 15 mg or 30 mg of
flurazepam hydrochloride, USP
and the following inactive ingredients: colloidal silicon dioxide,
magnesium stearate, microcrystalline
cellulose, powdered cellulose and sodium lauryl sulfate. The empty
gelatin capsule contains FD&C
Blue No. 1, FD&C Red No. 3, gelatin and titanium dioxide.
The imprinting ink contains black iron oxide, D&C Yellow No. 10
Aluminum Lake, FD&C Blue No. 1
Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum
Lake, propylene
glycol and shellac glaze.
CLINICAL PHARMACOLOGY
Flurazepam hydrochloride is rapidly absorbed from the G.I. tract.
Flurazepam is rapidly metabolized and
is excreted primarily in the urine. Following a single oral dose, peak
flurazepam plasma concentrations
ranging from 0.5 to 4.0 ng/mL occur at 30 to 60 minutes post-dosing.
The harmonic mean apparent half-
life of flurazepam is 2.3 hours. The blood level profile of flurazepam
and its major metabolites was
determined in man following the oral administration of 30 mg daily for
2 weeks. The N -hydroxyethyl-
flurazepam was measurable only during the early hours after a 30 mg
dose and was not detectable after
24 hours. The major metabolite in blood was N -desalkyl-flurazepam,
which reached steady-state
(plateau) levels after 7 to 10 days of dosing, at levels approximately
5- to 6-fold greater than the 24-
hour levels observed on Day 1. The half-life of elimination of N
-desalkyl-flurazepam ranged from 47
to 100 hours. The major urinary metabolite is conjugated N
-hydroxyethyl-flurazepam which accounts
for 22% t