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:

Chartwell RX, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including flurazepam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [ see Warnings and Precautions ( 5.9) and Clinical Considerations]. Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to flurazepam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to HALCION during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions ( 5.9)]. Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Administration of flurazepam to pregnant animals did not indicate a risk for adverse effects on morphological development at clinically relevant doses; however, animal data for other benzodiazepines suggest that possibility of adverse developmental effects (including long-term effects on neurobehavioral and immunological function) following prenatal exposure. Risk Summary There are no data on the presence of flurazepam in human or animal milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of flurazepam on milk production are unknown. Because of the flurazepam’s long half-life, the potential for flurazepam to accumulate in breast milk, and the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with flurazepam. Safety and effectiveness in pediatric patients have not been established. Flurazepam may cause confusion and over-sedation in the elderly. Elderly patients generally should be started on a low dose of flurazepam and observed closely. Elderly or debilitated patients may be more sensitive to benzodiazepines, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Flurazepam is a Schedule IV controlled substance. Flurazepam hydrochloride capsules are a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see Warnings and Precautions ( 5.2)] . The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol) . Physical Dependence:  Flurazepam hydrochloride capsules may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life- threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see Warnings and Precautions ( 5.3)]. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage [see Dosage and Administration ( 2.3) and Warnings and Precautions ( 5.3)]. Acute Withdrawal Signs and Symptoms: Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted Withdrawal Syndrome: Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months . As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance: Tolerance to flurazepam hydrochloride capsules may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of flurazepam hydrochloride capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of Flurazepam Hydrochloride, USP. Flurazepam Hydrochloride Capsules, USP 15 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 28 ” on the body with black ink, filled with white to off-white powder. They are available as follows, Bottle of 30's - NDC 62135-736-30 Bottle of 90’s - NDC 62135-736-90 Flurazepam Hydrochloride Capsules, USP 30 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 29 ” on the body with black ink, filled with white to off-white powder. They are available as follows, Bottle of 30's - NDC 62135-737-30 Bottle of 90’s - NDC 62135-737-90 Store at 20° to 25°C (68° to 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. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Chartwell RX, LLC
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Print Medication Guides at: www.chartwellpharma.com/medguides
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(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:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation).
Do not drive or operate heavy machinery until you know how taking
flurazepam hydrochloride capsules
with opioids affect you.
•
Riskofabuse, misuse,andaddiction.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.
•
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.
•
You can develop an addiction even if you take flurazepam hydrochloride
capsules exactly
as prescribed by your healthcare provider.
•
Take flurazepam hydrochloride capsules exactly as your healthcare
provider prescribed.
•
Do not share your flurazepam hydrochloride capsules with other people.
•
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 r

Summary of Product characteristics

FLURAZEPAM HYDROCHLORIDE- FLURAZEPAM HYDROCHLORIDE CAPSULE
CHARTWELL RX, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FLURAZEPAM HYDROCHLORIDE CAPSULES, USP
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._
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.
BEFORE PRESCRIBING FLURAZEPAM HYDROCHLORIDE CAPSULES AND THROUGHOUT
TREATMENT,
ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION ( 5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF FLURAZEPAM
HYDROCHLORIDE
CAPSULES AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH CAN
BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A
GRADUAL TAPER
TO DISCONTINUE FLURAZEPAM HYDROCHLORIDE CAPSULES OR REDUCE THE DOSAGE
( 2.3, 5.3).
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