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QUINIDINE GLUCONATE
QUINIDINE GLUCONATE is a drug. It is currently FDA-approved (first approved 1950).
Quinidine Gluconate is a small molecule that belongs to the drug class of blockers, specifically acting as a sodium channel alpha subunit blocker. It has been studied in clinical trials for various conditions, including major depressive disorder, episodic migraine, Alzheimer's disease, pseudobulbar affect, and as a combination with other medications.
At a glance
| Generic name | QUINIDINE GLUCONATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1950 |
Approved indications
Boxed warnings
- In many trials of antiarrhythmic therapy for non-life-threatening arrhythmias, active antiarrhythmic therapy has resulted in increased mortality; the risk of active therapy is probably greatest in patients with structural heart disease. In the case of quinidine used to prevent or defer recurrence of atrial flutter/fibrillation, the best available data come from a meta-analysis described under CLINICAL PHARMACOLOGY/Clinical Effects above. In the patients studied in the trials there analyzed, the mortality associated with the use of quinidine was more than three times as great as the mortality associated with the use of placebo. Another meta-analysis, also described under CLINICAL PHARMACOLOGY/Clinical Effects , showed that in patients with various non-life-threatening ventricular arrhythmias, the mortality associated with the use of quinidine was consistently greater than that associated with the use of any of a variety of alternative antiarrhythmics.
Common side effects
- Diarrhea
- Fever
- Rash
- Arrhythmia
- Abnormal electrocardiogram
- Nausea/Vomiting
- Dizziness
- Headache
- Asthenia
- Cerebral ischemia
- Heartburn/Esophagitis
- Tinnitus
Serious adverse events
- Hepatotoxicity/Granulomatous hepatitis
- Hemolytic anemia
- Thrombocytopenia
- Thrombocytopenic purpura
- Agranulocytosis
- Syncope
- Convulsions
- Acute psychotic reactions
- Bronchospasm
- Angioedema
Key clinical trials
- A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women (PHASE1)
- A Study of Imlunestrant (LY3484356) in Female Healthy Participants (PHASE1)
- Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury (PHASE2)
- Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants (PHASE1)
- A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants. (PHASE1)
- A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine (PHASE1)
- A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- QUINIDINE GLUCONATE CI brief — competitive landscape report
- QUINIDINE GLUCONATE updates RSS · CI watch RSS
Frequently asked questions about QUINIDINE GLUCONATE
What is QUINIDINE GLUCONATE?
QUINIDINE GLUCONATE is a Small molecule drug.
When was QUINIDINE GLUCONATE approved?
QUINIDINE GLUCONATE was first approved on 1950.
What development phase is QUINIDINE GLUCONATE in?
QUINIDINE GLUCONATE is FDA-approved (marketed).
What are the side effects of QUINIDINE GLUCONATE?
Common side effects of QUINIDINE GLUCONATE include Diarrhea, Fever, Rash, Arrhythmia, Abnormal electrocardiogram, Nausea/Vomiting. Serious adverse events: Hepatotoxicity/Granulomatous hepatitis, Hemolytic anemia, Thrombocytopenia, Thrombocytopenic purpura.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing