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:

Aidarex Pharmaceuticals LLC

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composition:

CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg

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: 30 TABLET in a BOTTLE (53217-183-30) 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. Repackaged by Aidarex Pharmaceuticals,LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aidarex Pharmaceuticals 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.
•
oDo not drive, operate heavy machinery, or do
other dangerous activities until you know how
chlordiazepoxide affects you.
•
oDo 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:
•
oto treat anxiety disorders
•
ofor the short-term relief of the symptoms of
anxiety
•
oto treat withdrawal symptoms of acute alcoholism
•
opreoperatively 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 hyd

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
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, 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, sodiu