Clorazepate Dipotassium 3.75 mg/1
Clorazepate Dipotassium · TABLET · Taro Pharmaceuticals U.S.A., Inc.
Clorazepate Dipotassium is a tablet containing clorazepate dipotassium at 3.75 mg/1, taken oral. Manufactured by Taro Pharmaceuticals U.S.A., Inc..
Key Facts
- Brand Name
- Clorazepate Dipotassium
- Generic Name
- Clorazepate Dipotassium
- NDC Code (Product)
51672-4042- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Strength
- 3.75 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA075731
- Marketing Start
- 04/27/2000
Recall History
Aurobindo Pharma USA Inc.
Discoloration: Dotted and yellow spots on tablets
Aurobindo Pharma USA Inc.
Discoloration: Dotted and yellow spots on tablets
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 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 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: 1st 24 hours (Day 1) 30 mg initially; followed by 30 to 60 mg in divided doses 2nd 24 hours (Day 2) 45 to 90 mg in divided doses 3rd 24 hours (Day 3) 22.5 to 45 mg in divided doses Day 4 15 to 30 mg in divided doses Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient's condition is stab…
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including clorazepate dipotassium, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe clorazepate dipotassium concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of clorazepate dipotassium than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking clorazepate dipotassium, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of res…
Contraindications
CONTRAINDICATIONS Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
Drug Interactions
DRUG INTERACTIONS The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. If clorazepate dipotassium is to be combined with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of the agents to be employed. Animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition. Clinical studies have shown increased sedation with concurrent hypnotic medications. The actions of the benzodiazepines may be potentiated by barbiturates, narcotics, phenothiazines, monoamine oxida…
Adverse Reactions
ADVERSE REACTIONS The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech. There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit. Decrease in systolic blood pressure has been observed. To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Clorazepate Dipotassium used for?
Clorazepate Dipotassium contains Clorazepate Dipotassium. It is a tablet taken oral. Consult your doctor for specific uses.
Is Clorazepate Dipotassium a controlled substance?
Yes, Clorazepate Dipotassium is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Clorazepate Dipotassium?
The generic name for Clorazepate Dipotassium is Clorazepate Dipotassium. There are 4 other brand versions of Clorazepate Dipotassium.
What is the NDC code for Clorazepate Dipotassium 3.75 mg/1?
The NDC (National Drug Code) for Clorazepate Dipotassium 3.75 mg/1 is 51672-4042, listed by Taro Pharmaceuticals U.S.A., Inc..