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:

Clinical Solutions Wholesale, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Product summary:

Chlordiazepoxide Hydrochloride Capsules USP, 5 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a yellow opaque body filled with white powder, imprinted in black ink “stylized barr” 158, packaged in bottles of 100 (NDC 0555-0158-02) and 500 (NDC 0555-0158-04) capsules, and blister cards of 30 (58118-1590-8). Chlordiazepoxide Hydrochloride Capsules USP, 10 mg are available as a two-piece hard gelatin capsule with a black opaque cap and a green opaque body filled with white powder, imprinted in white ink “stylized barr” 033, packaged in bottles of 100 (NDC 0555-0033-02) and 1000 (NDC 0555-0033-05) capsules. Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink “stylized barr” 159, available in bottles of 100 (NDC 0555-0159-02) and 500 (NDC 0555-0159-04) capsules. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. D 8/2016 Repackaged by: Clinical Solutions Wholesale Franklin, TN 37067

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Clinical Solutions Wholesale, LLC
----------
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.

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
CLINICAL SOLUTIONS WHOLESALE, LLC
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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
16
14
3
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,
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,