MEXILETINE HYDROCHLORIDE 200 mg/1
mexiletine hydrochloride · CAPSULE · Senores Pharmaceuticals, Inc.
MEXILETINE HYDROCHLORIDE is a capsule containing mexiletine hydrochloride at 200 mg/1, taken oral. Manufactured by Senores Pharmaceuticals, Inc..
Key Facts
- Brand Name
- MEXILETINE HYDROCHLORIDE
- Generic Name
- mexiletine hydrochloride
- NDC Code (Product)
82012-028- Manufacturer
- Senores Pharmaceuticals, Inc.
- Strength
- 200 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214089
- Marketing Start
- 11/29/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of mexiletine hydrochloride must be individualized on the basis of response and tolerance, both of which are dose-related. Administration with food or antacid is recommended. Initiate mexiletine therapy with 200 mg every eight hours when rapid control of arrhythmia is not essential. A minimum of two to three days between dose adjustments is recommended. Dose may be adjusted in 50 or 100 mg increments up or down. As with any antiarrhythmic drug, clinical and electrocardiographic evaluation (including Holter monitoring if necessary for evaluation) are needed to determine whether the desired antiarrhythmic effect has been obtained and to guide titration and dose adjustment. Satisfactory control can be achieved in most patients by 200 to 300 mg given every eight hours with food or antacid. If satisfactory response has not been achieved at 300 mg q8h, and the patient tolerates mexiletine well, a dose of 400 mg q8h may be tried. As the severity of CNS side effects increases with total daily dose, the dose should not exceed 1200 mg/day. In general, patients with renal failure will require the usual doses of mexiletine hydrochloride. Patients with sever…
Warnings
WARNINGS BOXED WARNING WARNINGS Mortality In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicentered, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3%). The average duration of treatment with encainide or flecainide in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain. Considering the known proarrhythmic properties of mexiletine and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of mexiletine as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmia. Acute Liver Injury In postmarketing experience abnormal liver function tests have bee…
Contraindications
CONTRAINDICATIONS Mexiletine hydrochloride capsules are contraindicated in the presence of cardiogenic shock or preexisting second- or third-degree AV block (if no pacemaker is present).
Adverse Reactions
ADVERSE REACTIONS Mexiletine hydrochloride commonly produces reversible gastrointestinal and nervous system adverse reactions but is otherwise well tolerated. Mexiletine has been evaluated in 483 patients in one month and three month controlled studies and in over 10,000 patients in a large compassionate use program. Dosages in the controlled studies ranged from 600 to 1200 mg/day; some patients (8%) in the compassionate use program were treated with higher daily doses (1600 to 3200 mg/day). In the three month controlled trials comparing mexiletine to quinidine, procainamide and disopyramide, the most frequent adverse reactions were upper gastrointestinal distress (41%), lightheadedness (10.5%), tremor (12.6%) and coordination difficulties (10.2%). Similar frequency and incidence were observed in the one month placebo-controlled trial. Although these reactions were generally not serious, and were dose-related and reversible with a reduction in dosage, by taking the drug with food or antacid or by therapy discontinuation, they led to therapy discontinuation in 40% of patients in the controlled trials. Table 1 presents the adverse events reported in the one-month placebo-controlled t…
Frequently Asked Questions
What is MEXILETINE HYDROCHLORIDE used for?
MEXILETINE HYDROCHLORIDE contains mexiletine hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is MEXILETINE HYDROCHLORIDE a controlled substance?
MEXILETINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for MEXILETINE HYDROCHLORIDE?
The generic name for MEXILETINE HYDROCHLORIDE is mexiletine hydrochloride. There are 5 other brand versions of mexiletine hydrochloride.
What is the NDC code for MEXILETINE HYDROCHLORIDE 200 mg/1?
The NDC (National Drug Code) for MEXILETINE HYDROCHLORIDE 200 mg/1 is 82012-028, listed by Senores Pharmaceuticals, Inc..