FLURAZEPAM HYDROCHLORIDE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

PD-Rx Pharmaceuticals, Inc.

INN（国際名）:

FLURAZEPAM HYDROCHLORIDE

構図:

FLURAZEPAM HYDROCHLORIDE 30 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies (14)]. 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 flurazepam or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of flurazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with flurazepam. There are no adequate and well-controlled studies in pr

製品概要:

Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of flurazepam hydrochloride, USP. 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: NDC 55289-038-30 bottles of 30 capsules 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.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

FLURAZEPAM HYDROCHLORIDE- flurazepam hydrochloride capsule
PD-Rx Pharmaceuticals, Inc.
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Medication Guide
Flurazepam Hydrochloride Capsules, USP
(flur az' e pam hye" droe klor' ide)
What is the most important information I should know about flurazepam
hydrochloride capsules?
•
Flurazepam hydrochloride 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.
•
Flurazepam hydrochloride capsules may cause serious side effects that
you may not know are
happening to you. These side effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
“sleep-walking” or doing other activities when you are asleep
like:
•
eating
•
talking
•
having sex
•
driving a car
Call your healthcare provider right away if you find out that you have
done any of the above activities after
taking flurazepam hydrochloride capsules.
•
Do not take flurazepam hydrochloride 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 flurazepam hydrochloride capsules than prescribed.
What are flurazepam hydrochloride capsules?
•
Flurazepam hydrochloride capsules are a prescription medicine used to
treat certain types of
insomnia including difficulty falling asleep, waking up often during
the night, or waking up early in
the morning.
•
Flurazepam hydrochloride is a federal controlled substance (C-IV)
because it can be abused or lead to
dependence. Keep in a safe place to prevent misuse and abuse. Selling
or giving away flurazepam
hydrochloride 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 flurazepam hydrochloride capsules are safe and
effective in children.
Do no

製品の特徴

FLURAZEPAM HYDROCHLORIDE- FLURAZEPAM HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLURAZEPAM
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FLURAZEPAM HYDROCHLORIDE CAPSULES.
FLURAZEPAM HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1970
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH _[_SEE _WARNINGS AND
PRECAUTIONS (5.1), DRUG_
_INTERACTIONS (7.1)] _.
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.
RECENT MAJOR CHANGES
Warnings and Precautions: CNS Depressant Effects and
Next-Day Impairment (5.2) 12/2018
INDICATIONS AND USAGE
Flurazepam, a gamma-aminobutyric (GABA
) agonist, is indicated for the treatment of insomnia
characterized by difficulty falling asleep, frequent nocturnal
awakenings, and/or early morning awakenings.
( 1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient.
Recommended initial dose is 15 mg for women and 15 mg or 30 mg for
men. ( 2.1)
Elderly or debilitated patients: recommended dose is 15 mg. ( 2.2)
DOSAGE FORMS AND STRENGTHS
15 mg and 30 mg capsules. ( 3)
CONTRAINDICATIONS
Pregnancy ( 4)
Hypersensitivity to flurazepam or other benzodiazepines. ( 4)
WARNINGS AND PRECAUTIONS
Concomitant use with opioids: May result in profound sedation,
respiratory depression, coma and
death. Reserve concomitant prescribing of benzodiazepines and opioids
for use in patients for whom
alternative treatment options are inadequate. ( 5.1)
CNS depressant effects: Impaired alertness and motor coordination,
including risk of falling. Daytime
i