CLORAZEPATE DIPOTASSIUM- clorazepate dipotassium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)

Available from:

Bryant Ranch Prepack

INN (International Name):

CLORAZEPATE DIPOTASSIUM

Composition:

CLORAZEPATE DIPOTASSIUM 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

Product summary:

Clorazepate Dipotassium Tablets USP are available as tablets containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP. The 3.75 mg tablets are round flat beveled edge, pale violet colored slightly mottled tablet. One side is scored and engraved with "T" above the score and "45" below the score. Other side is plain. Bottles of 100 (NDC 51672-4042-1) Bottles of 500 (NDC 51672-4042-2) Bottles of 1,000 (NDC 51672-4042-3) The 7.5 mg tablets are round flat beveled edge, orange colored, slightly mottled tablet. One side is scored and engraved with "T" above the score and "46" below the score. Other side is plain. Bottles of 100 (NDC 51672-4043-1) Bottles of 500 (NDC 51672-4043-2) Bottles of 1,000 (NDC 51672-4043-3) The 15 mg tablets are round flat beveled edge, pale pink colored, slightly mottled tablet. One side is scored and engraved with "T" above the score and "47" below the score. Other side is plain. Bottles of 100 (NDC 51672-4044-1) Bottles of 500 (NDC 51672-4044-2) Bottles of 1,000 (NDC 51672-4044-3) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Protect from moisture. Keep bottle tightly closed. Dispense in a USP tight, light-resistant container. Keep this and all medications out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
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MEDICATION GUIDE
CLORAZEPATE DIPOTASSIUM TABLETS, USP CIV
Read this Medication Guide before you start taking clorazepate
dipotassium tablets and each time you get
a refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about clorazepate
dipotassium tablets?
Do not stop taking clorazepate dipotassium tablets without first
talking to your healthcare provider.
Stopping clorazepate dipotassium tablets suddenly can cause serious
problems.
Clorazepate dipotassium tablets can cause serious side effects,
including:
1. Clorazepate dipotassium tablets 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
clorazepate dipotassium tablets affect you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clorazepate dipotassium tablets without first talking to your
healthcare provider. When taken with
alcohol or drugs that cause sleepiness or dizziness, clorazepate
dipotassium tablets may make your
sleepiness or dizziness much worse.
2. Clorazepate dipotassium tablets can cause abuse and dependence.
•
Do not stop taking clorazepate dipotassium tablets all of a sudden.
Stopping clorazepate
dipotassium tablets suddenly can cause seizures that do not stop,
hearing or seeing things that are
not there (hallucinations), shaking, and stomach and muscle cramps.
•
Talk to your doctor about slowly stopping clorazepate dipotassium
tablets to avoid getting
sick with withdrawal symptoms.
•
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell
you more about the differences between physical dependence and drug
addiction.
Clorazepate dipotassium tablets are a federally controlled substance
(C-IV) because it can be abused or
lead to dependence. Keep clorazepate di

Summary of Product characteristics

CLORAZEPATE DIPOTASSIUM- CLORAZEPATE DIPOTASSIUM TABLET
BRYANT RANCH PREPACK
----------
CLORAZEPATE
DIPOTASSIUM TABLETS USP,
3.75 MG, 7.5 MG, & 15 MG
CIV
RX ONLY
DESCRIPTION
Chemically, clorazepate dipotassium USP is a benzodiazepine. The
empirical formula is
C
H CIK N O ; the molecular weight is 408.92; 1_H_-1,
4-Benzodiazepine-3-carboxylic acid, 7-
chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with
potassium hydroxide (1:1) and the
structural formula may be represented as follows:
The compound occurs as a fine, light yellow, practically odorless
powder. It is insoluble in the
common organic solvents, but very soluble in water. Aqueous solutions
are unstable, clear, light
yellow, and alkaline.
Clorazepate dipotassium tablets USP contain 3.75 mg, 7.5 mg or 15 mg
of clorazepate dipotassium USP.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, magnesium
oxide heavy, magnesium stearate, microcrystalline cellulose, potassium
carbonate anhydrous, potassium
chloride, talc and the following coloring agents:
3.75 mg - D&C Blue No. 2 Lake and FD&C Red No. 40 Lake
7.5 mg - D&C Red No. 6 Lake and D&C Yellow No. 10 Lake
15 mg - D&C Red No. 6 Lake and FD&C Red No. 40 Lake
CLINICAL PHARMACOLOGY
Pharmacologically, clorazepate dipotassium has the characteristics of
the benzodiazepines. It has
depressant effects on the central nervous system. The primary
metabolite, nordiazepam, quickly appears
in the blood stream. The serum half-life is about 2 days. The drug is
metabolized in the liver and
excreted primarily in the urine.
Studies in healthy men have shown that clorazepate dipotassium has
depressant effects on the central
nervous system. Prolonged administration of single daily doses as high
as 120 mg was without toxic
effects. Abrupt cessation of high doses was followed in some patients
by nervousness, insomnia,
16
11
2
2
4
effects. Abrupt cessation of high doses was followed in some patients
by nervousness, insomnia,
irritability, diarrhea, muscle aches, or memory i