CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Golden State Medical Supply, Inc.

INN (International Adı):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Kompozisyon:

CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. Controlled Substance 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.

Ürün özeti:

Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC 60429-554-01), with S251 imprinted on the opaque green cap and Solco’s logo "S" imprinted on the opaque yellow body. 10 mg hard gelatin capsules in bottles of 100 (NDC 60429-555-01), with S252 imprinted on the opaque black cap and Solco’s logo "S" imprinted on the opaque green body. 25 mg hard gelatin capsules in bottles of 100 (NDC 60429-556-01, with S253 imprinted on the opaque green cap and Solco’s logo "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). Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Distributed by: Solco Healthcare U.S., LLC Cranbury, NJ 08512 Rev. 01/2021 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

CHLORDIAZEPOXIDE HYDROCHLORIDE- chlordiazepoxide hydrochloride
capsule, gelatin
coated
Golden State Medical Supply, Inc.
----------
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:
•
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
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.
•
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.
•
You can develop an addiction even if you take chlordiazepoxide
hydrochloride exactly as
prescribed by your healthcare provider.
•
Take chlordiazepoxide hydrochloride exactly as your healthcare
provider prescribed.
•
Do not share your chlordiazepoxide hydrochloride with other people.
•
Keep chlordiazepoxide hydrochloride in a safe place and away from
children.
•
Physical dependence and withdrawal reactions. Chlordiazepoxide
Hydroch

Ürün özellikleri

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE, GELATIN COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
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 HIGHER DAILY DOSE. ABRUPT
DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CHLORDIAZEPOXIDE
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
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES OR REDUCE THE DOSAGE (SEE
DOSAGE AND ADMINISTRATION AND WARNINGS).
DESCRIPTION
Chlordiazepoxide Hydrochloride, is the prototype for the
benzodiazepine compounds. It
is a versatile therapeutic agent of proven value for the relief of
anxiety. Chlordia