CHLORDIAZEPOXIDE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide HCI 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 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 HCI Capsules are contraindicated in patients with known hypersensitivity to the drug. Chlordiazepoxide HCI 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 discontinuance of chlordiazep

Product summary:

Chlordiazepoxide HCI Capsules is available as: 30 Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE
Contract Pharmacy Services-PA
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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 hydrochlo

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE
CONTRACT PHARMACY SERVICES-PA
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP
1000330103
RX ONLY
DESCRIPTION:
Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine
compounds.
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 of
chlordiazepoxide hydrochloride is as follows:
Available as capsules for oral administration containing either 5 mg,
10 mg or 25 mg of
chlordiazepoxide hydrochloride.
INACTIVE INGREDIENTS:
Hydrogenated vegetable oil, lactose anhydrous, microcrystalline
cellulose.
ACTIONS:
Chlordiazepoxide HCI has antianxiety, sedative, appetite-stimulating
and weak analgesic actions. The
precise mechanism of action is not known. The drug blocks EEG arousal
from stimulation of the brain
stem reticular formation. It takes several hours for peak blood levels
to be reached and the half-life of
the drug is between 24 and 48 hours. After the drug is discontinued
plasma levels decline slowly over a
period of several days. Chlordiazepoxide is excreted in the urine,
with 1 to 2% unchanged and 3 to 6%
as a conjugate.
ANIMAL PHARMACOLOGY:
The drug has been studied extensively in many species of animals and
these studies are suggestive of
action on the limbic system of the brain, which recent evidence
indicates is involved in emotional
responses.
Hostile monkeys were made tame by oral drug doses which did not cause
sedation. Chlordiazepoxide
revealed a “taming” action with the elimination of fear and
aggression. The taming effect of
chlordiazepoxide was further demonstrated in rats made vicious by
lesions in the septal area of the
brain. The drug dosage which effectively blocked the vicious reaction
was well below the dose which
caused sedation in these animals.
The LD
of parenterally a