Clorazepate Dipotassium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Clorazepate Dipotassium is an antianxiety that is FDA approved for the treatment of anxiety disorders or for the short-term relief of the symptoms of anxiety. Common adverse reactions include drowsiness, dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Dosage
For the Symptomatic Relief of Anxiety
- Clorazepate dipotassium tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 15 mg to 60 mg daily in accordance with the response of the patient. In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 mg to 15 mg.
- Clorazepate dipotassium tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. After the initial dose, the response of the patient may require adjustment of subsequent dosage. Lower doses may be indicated in the elderly patient. Drowsiness may occur at the initiation of treatment and with dosage increment.
- For the Symptomatic Relief of Acute Alcohol Withdrawal
The following dosage schedule is recommended:
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clorazepate Dipotassium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Clorazepate Dipotassium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Clorazepate Dipotassium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clorazepate Dipotassium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Clorazepate Dipotassium in pediatric patients.
Contraindications
There is limited information regarding Clorazepate Dipotassium Contraindications in the drug label.
Warnings
There is limited information regarding Clorazepate Dipotassium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clorazepate Dipotassium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Clorazepate Dipotassium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Clorazepate Dipotassium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Clorazepate Dipotassium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clorazepate Dipotassium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Clorazepate Dipotassium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Clorazepate Dipotassium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Clorazepate Dipotassium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Clorazepate Dipotassium in geriatric settings.
Gender
There is no FDA guidance on the use of Clorazepate Dipotassium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Clorazepate Dipotassium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Clorazepate Dipotassium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Clorazepate Dipotassium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clorazepate Dipotassium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Clorazepate Dipotassium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Clorazepate Dipotassium Administration in the drug label.
Monitoring
There is limited information regarding Clorazepate Dipotassium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Clorazepate Dipotassium and IV administrations.
Overdosage
There is limited information regarding Clorazepate Dipotassium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Clorazepate Dipotassium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Clorazepate Dipotassium Mechanism of Action in the drug label.
Structure
There is limited information regarding Clorazepate Dipotassium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Clorazepate Dipotassium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Clorazepate Dipotassium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Clorazepate Dipotassium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Clorazepate Dipotassium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Clorazepate Dipotassium How Supplied in the drug label.
Storage
There is limited information regarding Clorazepate Dipotassium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Clorazepate Dipotassium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Clorazepate Dipotassium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Clorazepate Dipotassium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Clorazepate Dipotassium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.