CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aphena Pharma Solutions - Tennessee, LLC

INN (Mezinárodní Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Složení:

CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Chlordiazepoxide Hydrochloride Capsule is 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 Hydrochloride Capsule 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 Hydrochloride Capsule is 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 occurre

Přehled produktů:

Chlordiazepoxide Hydrochloride. Capsules are available in the following presentations: 5 mg hard gelatin capsules in bottles of 90 (NDC 42291-210-90), with S251 imprinted on the opaque green cap and Solco’s logo “S” imprinted on the opaque yellow body. 10 mg hard gelatin capsules in bottles of 90 (NDC 42291-211-90), with S252 imprinted on the opaque black cap and Solco’s logo “S” imprinted on the opaque green body. 25 mg hard gelatin capsules in bottles of 90 (NDC 42291-212-90), with S253 imprinted on the opaque green cap and Solco’s logo “S” imprinted on the opaque white body. Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 10/12 AV Rev. 02/15 (P)

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Aphena Pharma Solutions - Tennessee, LLC
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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.
•
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
chlordi

Charakteristika produktu

CHLORDIAZEPOXIDE HYDROCHLORIDE - CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE, GELATIN
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Chlordiazepoxide Hydrochloride Capsules, USP, the original
Chlordiazepoxide Hydrochloride and
prototype for the benzodiazepine compounds, was synthesized and
developed at Hoffmann-La Roche
Inc. It is a versatile therapeutic agent of proven value for the
relief of anxiety. Chlordiazepoxide
Hydrochloride Capsule is among the safer of the effective
psychopharmacologic compounds available,
as demonstrated by extensive clinical evidence.
Chlordiazepoxide Hydrochloride is available as capsules containing 5
mg, 10 mg or 25 mg
chlordiazepoxide hydrochloride. Each capsule also contains corn
starch, lactose monohydrate and talc.
Gelatin capsule shells may contain methyl and propyl parabens,
Titanium Dioxide, Gelatin and potassium
sorbate, with the following dye systems: 5-mg capsules - FD and C
Yellow No. 6 plus D and C Yellow
No. 10 and FD and C Green No. 3. 10-mg capsules - D and C Yellow No.
10, FD and C Blue No. 1, FD
and C Green No. 3, FD and C Yellow No.6 plus FD and C Red No. 40.
25-mg capsules - D and C
Yellow No. 10 and FD and C Green No. 3.
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
molecular weight is 336.22. The
structural formula of chlordiazepoxide hydrochloride is as follows:
CLINICAL PHARMACOLOGY
Chlordiazepoxide hydrochloride 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 leve