CHLORDIAZEPOXIDE HYDROCHLORIDE- 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:

REMEDYREPACK INC.

INN (International Adı):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Kompozisyon:

CHLORDIAZEPOXIDE HYDROCHLORIDE 25 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. Chlordiazepoxide hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have oc

Ürün özeti:

Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC 43547-251-10), 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 43547-252-10), 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 43547-253-10), 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 – 30°C (59°F – 86°F). Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Distributed by: Solco Healthcare U.S., LLC Cranbury, NJ 08512 Rev. 12/2017 OE1413

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE, GELATIN
COATED
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride
Capsules, USP C-IV
What is the most important information I should know about
chlordiazepoxide?
•
Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines
with opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death.
•
Chlordiazepoxide can make you sleepy or dizzy, and can slow your
thinking and motor skills.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know
how chlordiazepoxide affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
chlordiazepoxide without first talking to your healthcare provider.
When taken with
alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide
may make your
sleepiness or dizziness much worse.
•
Do not take more chlordiazepoxide than prescribed.
What is chlordiazepoxide?
•
Chlordiazepoxide is a prescription medicine used:
•
to treat anxiety disorders
•
for the short-term relief of the symptoms of anxiety
•
to treat withdrawal symptoms of acute alcoholism
•
preoperatively to treat apprehension and anxiety
•
Chlordiazepoxide is a federal controlled substance (C-IV) because it
can be abused or lead to
dependence. Keep chlordiazepoxide in a safe place to prevent misuse
and abuse. Selling or giving
away chlordiazepoxide may harm others, and is against the law. Tell
your healthcare provider if
you have abused or been dependent on alcohol, prescription medicines
or street drugs.
•
It is not known if chlordiazepoxide is safe and effective in children
under 6 years of age.
•
It is not known if chlordiazepoxide is safe and effective for use for
longer than 4 months.
Do not take chlordiazepoxide if you are allergic to chlordiazepoxide
or to any of the ingredients in
Chlordi

Ürün özellikleri

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE, GELATIN
COATED
REMEDYREPACK INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death _[_see _Warnings, Drug Interactions]_.
• Reserve concomitant prescribing of these drugs for use 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.
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
sorbate, with the following dye
systems: 5-mg capsules – FD&C Yellow No. 6 plus D&C Yellow No. 10
and either FD&C Blue No. 1
or FD&C Green No. 3. 10-mg capsules – D&C Yellow No. 10 and either
FD&C Blue No. 1 plus
FD&C Red No. 3 or FD&C Green No. 3 plus FD&C Red No. 40. 25-mg
capsules– D&C Yellow No.
10 and either FD&C Green No. 3 or FD&C Blue No. 1.
Chlordiazepoxide Hydrochloride is
7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-
oxide hydrochloride. A white to practically white crystalline
substance, it is soluble in water. It is
unstable in solution and the powder must be protected from light. The
molecular weight is 336.22. The
structural formula of chlordiazepoxide hydrochloride is as follows:
CLINICAL PHARMACOLOGY
Chlordiazepoxide Hydrochloride has antianxiety, sedative,
appetite-stimulating