QUINIDINE SULFATE 300 mg/1
quinidine sulfate tablet · TABLET · EPIC PHARMA, LLC
Quinidine sulfate is an oral antiarrhythmic medication used to treat certain types of irregular heart rhythms. It works by slowing electrical activity in the heart to help restore and maintain a normal heart rate.
Key Facts
- Brand Name
- QUINIDINE SULFATE
- Generic Name
- quinidine sulfate tablet
- NDC Code (Product)
42806-512- Manufacturer
- EPIC PHARMA, LLC
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA088072
- Marketing Start
- 12/15/2021
Recall History
Aidapak Services, LLC
Labeling: Label Mixup:quiNIDine SULFATE, Tablet, 200 mg may have potentially been mislabeled as the following drug: QUINAPRIL, Tablet, 40 mg, NDC 31722027090, Pedigree: AD52778_76, EXP: 5/21/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury. Dextromethorphan hydrobromide and quinidine sulfate capsules are a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of pseudobulbar affect (PBA). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting dose: one capsule daily by mouth for 7 days. ( 2.1 ) Maintenance dose: After 7 days, 1 capsule every 12 hours. ( 2.1 ) 2.1 Recommended Dose The recommended starting dose of dextromethorphan hydrobromide and quinidine sulfate capsules are one capsule daily by mouth for the initial seven days of therapy. On the eighth day of therapy and thereafter, the daily dose should be a total of two capsules a day, given as one capsule every 12 hours. The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients.
Contraindications
4 CONTRAINDICATIONS Concomitant use with quinidine, quinine, or mefloquine. ( 4.1 ) Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions. ( 4.2 ) Patients with known hypersensitivity to dextromethorphan. ( 4.2 ) Use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping dextromethorphan hydrobromide and quinidine sulfate before starting an MAOI. ( 4.3 ) Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure. ( 4.4 ) Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block. ( 4.4 ) Concomitant use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide). ( 4.4 ) 4.1 Quinidine and Related Drugs Dextromethorphan hydrobromide and quinidine sulfate capsules contain quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. 4.2 Hypersensitivity Dextromethorphan hydrobromide and quinidine sulfate capsules are contraindicated in patients with a history of dextromethorphan hydrobr…
Drug Interactions
7 DRUG INTERACTIONS Desipramine: Exposure increases 8-fold. Reduce desipramine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Paroxetine: Exposure increases 2-fold. Reduce paroxetine dose and adjust based on clinical response. ( 7.5 , 12.4 ) Digoxin: Increased digoxin substrate plasma concentration may occur. ( 7.6 ) 7.1 MAOIs Do not use dextromethorphan hydrobromide and quinidine sulfate with monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days [see Contraindications ( 4.3 )] . 7.2 Drugs that Prolong QT and are Metabolized by CYP2D6 Do not use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide) [see Contraindications ( 4.4 )] . 7.3 Drugs that Prolong QT and Concomitant CYP3A4 Inhibitors Recommend ECG in patients taking drugs with dextromethorphan hydrobromide and quinidine sulfate that prolong the QT interval and in patients taking concomitant moderate or strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.3 )] . 7.4 SSRIs and Tricyclic Antidepressants Use of dextromethorphan hydrobromide and quinidine sulfate with SSRIs or tricyclic antidepressants increases the…
Adverse Reactions
6 ADVERSE REACTIONS A total of 946 patients participated in four Phase 3 controlled and uncontrolled PBA studies and received at least one dose of the combination product of dextromethorphan/quinidine in various strengths at the recommended or higher than the recommended dose. Of those patients, 393 patients were exposed for at least 180 days and 294 patients were exposed for at least one year. Median exposure was 168 days. Controlled trials enrolled only patients with either ALS or MS. Uncontrolled studies enrolled 136 patients with PBA secondary to a wide variety of underlying neurological conditions including stroke (45 patients) and traumatic brain injury (23 patients). Consequently, patients with other underlying neurologic diseases may experience other adverse reactions not described below. The most common adverse reactions (incidence of ≥ 3% and two-fold greater than placebo) in patients taking dextromethorphan hydrobromide and quinidine sulfate are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited…
Frequently Asked Questions
What is QUINIDINE SULFATE used for?
Quinidine sulfate is an oral antiarrhythmic medication used to treat certain types of irregular heart rhythms. It works by slowing electrical activity in the heart to help restore and maintain a normal heart rate.
Is QUINIDINE SULFATE a controlled substance?
QUINIDINE SULFATE is not classified as a controlled substance by the DEA.
What is the generic name for QUINIDINE SULFATE?
The generic name for QUINIDINE SULFATE is quinidine sulfate tablet. There are no other listed brand versions of quinidine sulfate tablet.
What is the NDC code for QUINIDINE SULFATE 300 mg/1?
The NDC (National Drug Code) for QUINIDINE SULFATE 300 mg/1 is 42806-512, listed by EPIC PHARMA, LLC.
Other QUINIDINE SULFATE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)