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:

Apotex Corp.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clorazepate dipotassium tablets are 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. Controlled Substance Clorazepate dipot

Product summary:

3.75 mg Tablets Clorazepate dipotassium tablets, USP are available as light blue colored, round, mottled uncoated tablets, debossed with "C" above the bisect, "19" below the bisect on one side and plain on other side. Each tablet contains 3.75 mg of clorazepate dipotassium. Bottles of 30 (NDC 60505-4754-3) Bottles of 100 (NDC 60505-4754-1) Bottles of 500 (NDC 60505-4754-5) Bottles of 1000 (NDC 60505-4754-7) 7.5 mg Tablets Clorazepate dipotassium tablets, USP are available as light peach colored, round, mottled uncoated tablets, debossed with "C" above the bisect, "20" below the bisect on one side and plain on other side. Each tablet contains 7.5 mg of clorazepate dipotassium. Bottles of 30 (NDC 60505-4755-3) Bottles of 100 (NDC 60505-4755-1) Bottles of 500 (NDC 60505-4755-5) Bottles of 1000 (NDC 60505-4755-7) 15 mg Tablets Clorazepate dipotassium tablets, USP are available as pink colored, round, mottled uncoated tablets, debossed with "C" above the bisect, "21" below the bisect on one side and plain on other side. Each tablet contains 15 mg of clorazepate dipotassium. Bottles of 30 (NDC 60505-4756-3) Bottles of 100 (NDC 60505-4756-1) Bottles of 500 (NDC 60505-4756-5) Bottles of 1000 (NDC 60505-4756-7) Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. APOTEX INC. Clorazepate Dipotassium Tablets, USP 3.75 mg, 7.5 mg and 15 mg Revised: May 2023 Rev: 4

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Apotex Corp.
----------
MEDICATION GUIDE
Clorazepate Dipotassium Tablets, USP CIV
(klor az’ e pate dye" poe tas’ ee um)
What is the most important information I should know about clorazepate
dipotassium tablets?
•
Clorazepate dipotassium is a benzodiazepine medicine. Taking
benzodiazepines with opioid
medicines, alcohol, or other central nervous system (CNS) depressants
(including street drugs) can
cause severe drowsiness, breathing problems (respiratory depression),
coma and death. Get
emergency help right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clorazepate
dipotassium tablets and opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including clorazepate dipotassium tablets which can
lead to overdose and serious
side effects including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including clorazepate dipotassium tablets.
These serious side
effects may also include delirium, paranoia, suicidal thoughts or
actions, seizures, and
difficulty breathing. Call your healthcare provider or go to the
nearest hospital emergency
room right away if you get any of these serious side effects.
•
You can develop an addiction even if you take clorazepate dipotassium
tablets as
prescribed by your healthcare provider
•
Take clorazepate dipotassium tablets exactly as your healthcare
provider prescribed.
•
Do not share your clorazepate dipotassium tablets with other people.
•
Keep clorazepate dipotassium tablets in a safe place and away from
children.
•
Physical dependence and withdrawal reactions. Clorazepate dipotassium
tablets can cause physical
dependence and withdrawal reactions,.
•
Do not suddenly stop taking clorazepate dipotassium tablets. Stopping
cloraze

Summary of Product characteristics

CLORAZEPATE DIPOTASSIUM- CLORAZEPATE DIPOTASSIUM TABLET
APOTEX CORP.
----------
CLORAZEPATE DIPOTASSIUM TABLETS, USP CIV 3.75 MG, 7.5 MG, 15 MG
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS 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 (SEE WARNINGS
AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CLORAZEPATE DIPOTASSIUM
TABLETS, EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION,
WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE AND MISUSE OF
BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF OTHER
MEDICATIONS, ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS ASSOCIATED
WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES. BEFORE
PRESCRIBING CLORAZEPATE DIPOTASSIUM TABLETS AND THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLORAZEPATE
DIPOTASSIUM TABLETS, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL
DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL INCREASE WITH
LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT
DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CLORAZEPATE DIPOTASSIUM
TABLETS AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF
WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE CLORAZEPATE
DIPOTASSIUM TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND
ADMINISTRATION AND WARNINGS).
DESCRIPTION
Chemically, clorazepate dipotassium is a benzodiazepine. The molecular
formula is
C
H
ClK N O ; the molecular weight is 408.92 g/mol; 1_H_-1, 4
Benzodiazepine-3-
carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt
compound with