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:

ATLANTIC BIOLOGICALS CORP.

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 discon

Product summary:

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 Bingo card of 30ct (NDC 17856-0164-01) 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 DISTRIBUTED BY : ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ATLANTIC BIOLOGICALS CORP.
----------
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

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
ATLANTIC BIOLOGICALS CORP.
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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-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 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,
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
16
14
3
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