CHLORDIAZEPOXIDE HYDROCHLORIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Chartwell RX, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Abuse 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 ef

Tóm tắt sản phẩm:

Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg: Light green and yellow, size #4 hard gelatin capsules, filled with white to off-white powder, imprinted “CE” on the cap and “81” on the body in black ink. Bottles of 60 (NDC 62135-220-60) 10 mg: Black and green, size #4 hard gelatin capsules, filled with white to off-white powder, imprinted “CE” on the cap and “82” on the body in white ink. Bottles of 60 (NDC 62135-221-60) 25 mg: Light green and white, size #4 hard gelatin capsules, filled with white to off-white powder, imprinted “CE” on the cap and “83” on the body in black ink. Bottles of 60 (NDC 62135-222-60) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: CorePharma, LLC Middlesex, NJ 08846 Manufactured for: Chartwell RX, LLC Congers, NY 10920 L70777 Rev 11/2022 Dispense with Medication Guide available at www.chartwellpharma.com/medguides

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Chartwell RX, LLC
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MEDICATION GUIDE
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
Hydrochloride can cause
physical dependence and withdrawal reactions, especially if you
continue

Đặc tính sản phẩm

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
CHARTWELL RX, LLC
----------
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. Chlordiazepoxide
Hydrochloride is among