Dipotassium

• 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 contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.contraindicated

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 stable. The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days. As an Adjunct to Antiepileptic Drugs In order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded. Adults The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day.

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 respiratory depression and sedation when clorazepate dipotassium is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS: Drug Interactions ).

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.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Dependence and Withdrawal Reactions ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

• Jul 17, 1987ANDAANDA071858Aurobindo Pharma
• Apr 27, 2000ANDAANDA075731Taro
• Jun 14, 2022ANDAANDA215566Corepharma
• Jun 16, 2022ANDAANDA213730Novitium Pharma
• Jun 28, 2024NDANDA210661Avyxa Holdings

1. 1Nausea1357.2%
2. 2Somnolence1286.8%
3. 3Drug Ineffective1256.6%
4. 4Drug Interaction1186.3%
5. 5Off Label Use1045.5%
6. 6Intentional Overdose975.1%
7. 7Suicide Attempt965.1%
8. 8Diarrhoea924.9%
9. 9Fatigue914.8%
10. 10Dizziness894.7%
11. 11Fall884.7%
12. 12Anxiety874.6%
13. 13Headache864.6%
14. 14Toxicity To Various Agents844.5%
15. 15Vomiting824.4%

The 10 most recently updated of 13 ClinicalTrials.gov registrations naming Dipotassium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Dipotassium Oxalate for Postoperative Sensitivity in NCCLs
  Not yet recruiting · Interventional · 64 enrolled · Postgraduate Medical Institute, Lahore
  NCT07540299updated 2026-04-22
• Skin Barrier Function and Inflammation in Aging: The BIA Study
  Recruiting · Phase 4 · Interventional · 32 enrolled · University of California, San Francisco
  NCT06750653updated 2026-03-06
• Predictors of Emergency Department Use in Frail Patients
  Recruiting · Observational · 110 enrolled · University of Pisa
  NCT07259499updated 2025-12-02
• Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
  Terminated · Phase 3 · Interventional · 323 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04726592updated 2025-09-08
• Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis
  Completed · Interventional · 120 enrolled · The Affiliated Hospital of Xuzhou Medical University
  NCT06565117updated 2024-08-21
• Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
  Completed · Interventional · 40 enrolled · University of Memphis
  NCT05592951updated 2023-09-26
• Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
  Terminated · Phase 4 · Interventional · 100 enrolled · Polish Lymphoma Research Group
  NCT02323659updated 2022-01-13
• PRP-HA Versus HA in Knee Osteoarthritis
  Unknown · Phase 2 · Phase 3 · Interventional · 132 enrolled · Singapore General Hospital
  NCT05076526updated 2021-10-13
• A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
  Completed · Interventional · 120 enrolled · Procter and Gamble
  NCT03965039updated 2020-10-30
• An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
  Completed · Interventional · 60 enrolled · University of Minnesota
  NCT02476032updated 2017-10-23

Frequently asked questions

What is Dipotassium used for?

According to FDA labeling, Dipotassium carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Dipotassium?

Dipotassium labeling lists contraindications including: Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.. Always consult the full prescribing information and a clinician.