CHLORDIAZEPOXIDE HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

A-S Medication Solutions

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Chlordiazepoxide HCl 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 HCl 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 HCl 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 occurred following abrupt discon

產品總結:

Product: 50090-0328 NDC: 50090-0328-3 30 CAPSULE in a BOTTLE

授权状态:

Abbreviated New Drug Application

资料单张

A-S Medication Solutions
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MEDICATION GUIDE
MEDICATION GUIDE
Chlordiazepoxide (KLOR-dye-AZ-e-POX-ide)
Hydrochloride Capsules, 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
chlordiazepoxide hydrochloride capsules.
See the e

产品特点

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
A-S MEDICATION SOLUTIONS
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES USP CIV
RX ONLY
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 7-chloro-2-
(methylamino)-5-phenyl-3_H_-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 structural formula is:
C
H
ClN O • HCl M.W. 336.22
Each capsule, for oral administration, contains either 5 mg, 10 mg or
25 mg of
chlordiazepoxide hydrochloride, USP and has the following inactive
ingredients:
anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, FD&C blue no. 1
aluminum lake,
16
14
3
gelatin, hydrogenated vegetable oil, microcrystalline cellulose,
pharmaceutical glaze, and
titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10
aluminum lake,
FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake,
propylene glycol, and
synthetic black iron oxide. In addition, the 5 mg contains D&C red no.
33 and the 10 mg
also contains butyl paraben, edetate calcium disodium, dimethyl
polysiloxane, ethylene
glycol monoethyl ether, FD&C red no. 40, methyl paraben, propyl
paraben, sodium,
sodium la