FLURAZEPAM- flurazepam hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

FLURAZEPAM HYDROCHLORIDE

Composition:

FLURAZEPAM HYDROCHLORIDE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Flurazepam Hydrochloride Capsules are 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. Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated wi

Product summary:

Flurazepam Hydrochloride Capsules USP 30 mg: Blue/blue, No. 2 hard gelatin capsule printed “West-ward Flurazepam 30”.NDC 21695-363-30 Bottles of 30 capsules                                       Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLURAZEPAM- FLURAZEPAM HYDROCHLORIDE CAPSULE
Rebel Distributors Corp
----------
MEDICATION GUIDE
Flurazepam (flew-raz-e-pam) HCl Capsules, 15 mg and 30 mg, are a
Sedative-Hypnotic indicated for
Insomnia
CIV
Rx Only
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 you have done any
of the above activi

Summary of Product characteristics

FLURAZEPAM- FLURAZEPAM HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
----------
FLURAZEPAM HYDROCHLORIDE CAPSULES, USP
CIV
Rev. 06/09
RX ONLY
DESCRIPTION
Flurazepam hydrochloride is chemically
7-chloro-1-[2(diethylamino)ethyl]-5-(_o_-fluorophenyl)-1,3-
dihydro-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 15 mg or 30 mg of
flurazepam hydrochloride. In addition,
each capsule contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
pregelatinized starch , and sodium starch glycolate. Capsules shells
may contain: colloidal silicon
dioxide, FD&C Blue No. 1, FD&C Red No. 3, gelatin, silicon dioxide,
sodium lauryl sulfate, and
titanium dioxide.
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
five- to sixfold 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 to 55 percent of the dose. Less than 1% of the dose is excreted
in the urine as N -desalkyl-
flurazepam.
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