Mexiletine Hcl
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FDA Labeling Changes
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Uses
Mexiletine Hydrochloride Capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement 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.
History
There is currently no drug history available for this drug.
Other Information
Mexiletine hydrochloride is an orally active antiarrhythmic agent available as 150 mg, 200 mg and 250 mg capsules. 100 mg of mexiletine hydrochloride is equivalent to 83.31 mg of mexiletine base. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride has a pKa of 9.2.
Chemically, mexiletine hydrochloride is (±)-1-methyl-2-(2, 6-xylyloxy) ethylamine hydrochloride. Its molecular formula is C11H17NO•HCI and molecular weight is 215.72.
Following is its structural formula:
Each capsule, for oral administration contains 150 mg, 200 mg, or 250 mg mexiletine hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Mexiletine hydrochloride capsules 150 mg also contain black iron oxide, red iron oxide, and yellow iron oxide. Mexiletine hydrochloride capsules 250 mg also contain FD&C Green No. 3.
Sources
Mexiletine Hcl Manufacturers
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Watson Laboratories, Inc.
![Mexiletine Hcl (Mexiletine Hydrochloride) Capsule [Watson Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mexiletine Hcl | Watson Laboratories, Inc.
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 severe liver disease, however, may require lower doses and must be monitored closely. Similarly, marked right-sided congestive heart failure can reduce hepatic metabolism and reduce the needed dose. Plasma level may also be affected by certain concomitant drugs (seePRECAUTIONS: Drug Interactions).
Loading Dose: When rapid control of ventricular arrhythmia is essential, an initial loading dose of 400 mg of mexiletine hydrochloride may be administered, followed by a 200 mg dose in eight hours. Onset of therapeutic effect is usually observed within 30 minutes to two hours.
Q12H Dosage Schedule: Some patients responding to mexiletine may be transferred to a 12 hour dosage schedule to improve convenience and compliance. If adequate suppression is achieved on a mexiletine hydrochloride dose of 300 mg or less every eight hours, the same total daily dose may be given in divided doses every 12 hours while carefully monitoring the degree of suppression of ventricular ectopy. This dose may be adjusted up to a maximum of 450 mg every 12 hours to achieve the desired response.
Transferring to Mexiletine hydrochloride: The following dosage schedule, based on theoretical considerations rather than experimental data, is suggested for transferring patients from other Class 1 oral antiarrhythmic agents to mexiletine: Mexiletine hydrochloride treatment may be initiated with a 200 mg dose, and titrated to response as described above, 6 to 12 hours after the last dose of quinidine sulfate, 3 to 6 hours after the last dose of procainamide, 6 to 12 hours after the last dose of disopyramide or 8 to 12 hours after the last dose of tocainide.
In patients in whom withdrawal of the previous antiarrhythmic agent is likely to produce life-threatening arrhythmias, hospitalization of the patient is recommended.
When transferring from lidocaine to mexiletine, the lidocaine infusion should be stopped when the first oral dose of mexiletine hydrochloride is administered. The infusion line should be left open until suppression of the arrhythmia appears to be satisfactorily maintained. Consideration should be given to the similarity of the adverse effects of lidocaine and mexiletine and the possibility that they may be additive.
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