CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)

Доступно од:

Epic Pharma LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Chlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide hydrochloride capsules in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Chlordiazepoxide Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to the drug. Chlordiazepoxide is a Schedule IV controlled substance. Chlordiazepoxide is 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 intent

Резиме производа:

Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC 42806-561-01), with S251 imprinted on the opaque green cap and “S” imprinted on the opaque yellow body. 10 mg hard gelatin capsules in bottles of 100 (NDC 42806-562-01), with S252 imprinted on the opaque black cap and “S” imprinted on the opaque green body. 25 mg hard gelatin capsules in bottles of 100 (NDC 42806-563-01), with S253 imprinted on the opaque green cap and “S” imprinted on the opaque white body. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 04-2021-00 MF561REV04/21 LN0002

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Epic Pharma LLC
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Medication Guide
Chlordiazepoxide Hydrochloride
(klor″ dye az″ e pox′ ide hye″droe klor′ ide)
Capsules USP, C-IV
What is the most important information I should know about
chlordiazepoxide hydrochloride?
•
Chlordiazepoxide Hydrochloride is a benzodiazepine medicine. Taking
benzodiazepines with opioid
medicines, alcohol, or other central nervous system depressants (CNS)
(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
chlordiazepoxide hydrochloride
with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including chlordiazepoxide hydrochloride, 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 chlordiazepoxide hydrochloride. 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 chlordiazepoxide
hydrochloride exactly as prescribed
by your healthcare provider.
o
Take chlordiazepoxide hydrochloride exactly as your healthcare
provider prescribed.
o
Do not share your chlordiazepoxide hydrochloride with other people.
o
Keep chlordiazepoxide hydrochloride in a safe place and away from
children.
•
Physical dependence and withdrawal reactions. Chlordiazepoxide
Hydrochloride can cause physical
dependence and withdrawal reactions, especially if you continue to
take chlordiazepoxide
hydrochlor

Карактеристике производа

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE, GELATIN COATED
EPIC PHARMA LLC
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Chlordiazepoxide Hydrochloride, is the prototype for the
benzodiazepine compounds. It
is a versatile therapeutic agent of proven value for the relief of
anxiety. Chlordiazepoxide
Hydrochloride is among the safer of the effective psychopharmacologic
compounds
available, as demonstrated by extensive clinical evidence.
Chlordiazepoxide Hydrochloride is available as capsules containing 5
mg, 10 mg or 25
mg chlordiazepoxide hydrochloride. Each capsule also contains corn
starch, lactose and
talc. Gelatin capsule shells may contain methyl and propyl parabens
and potassium
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULES, EXPOSES USERS TO RISK 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 CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES AND THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULES, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL
DEPENDENCE. THE RISK OF DEPENDENCE AND WITHDRAWAL INCREASE WITH
LONGER TREATMENT DURATION AND HIGH