FLURAZEPAM HYDROCHLORIDE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Pharmaceuticals Inc.

INN (nemzetközi neve):

FLURAZEPAM HYDROCHLORIDE

Összetétel:

FLURAZEPAM HYDROCHLORIDE 15 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 pregnant women. Available human

Termék összefoglaló:

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: NDC 0378-4415-01 bottles of 100 capsules 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 0378-4430-01 bottles of 100 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Flurazepam Hydrochloride Capsules, USP CIV
(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 (CNS)
depressants (including street
drugs) can cause severe drowsiness, breathing problems (respiratory
depression), coma and death.
Get emergency help right away if any of the following happens:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation).
Do not drive or operate heavy machinery until you know how taking
flurazepam hydrochloride
capsules with opioids affect you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including flurazepam hydrochloride capsules, which
can lead to overdose and
serious side effects including coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including flurazepam hydrochloride capsules.
These serious side
effects may also include delirium, paranoia, suicidal thoughts or
actions, seizures, and
difficulty breathing. Call your healthcare provider or go to the
nearest hospital emergency
room right away if you get any of these serious side effects.
o
You can develop an addiction even if you take flurazepam hydrochloride
capsules exactly as
prescribed by your healthcare provider.
o
Take flurazepam hydrochloride capsules exactly as your healthcare
provider prescribed.
o
Do not share your flurazepam hydrochloride capsules with other people.
o
Keep flurazepam hydrochloride capsules in a safe place and away from
children.
•
Physical dependence and withdrawal reactions. Flurazepam hydrochloride
capsules can cause
physical dependence and withdrawal reactions, especially if you
continue to take flurazepam

Termékjellemzők

FLURAZEPAM HYDROCHLORIDE- FLURAZEPAM HYDROCHLORIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
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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 CIV
INITIAL U.S. APPROVAL: 1970
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 2/2021
Dosage and Administration (2.3) 2/2021
Warnings and Precautions (5.1, 5.2, 5.3) 2/2021
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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS 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
(5.1, 7.1).
THE USE OF BENZODIAZEPINES, INCLUDING FLURAZEPAM HYDROCHLORIDE
CAPSULES,
EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD
TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS
ASSOCIATED WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES.
BEFORE
PRESCRIBING FLURAZEPAM HYDROCHLORIDE CAPSULES, AND THROUGHOUT
TREATMENT, ASSESS
EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (5.2).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING FLURAZEPAM
HYDROCHLORIDE
CAPSULES, MAY LEA