"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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MEXITIL (mexiletine hydrochloride, USP) is 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 MEXITIL (mexiletine hcl) , its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of MEXITIL (mexiletine hcl) 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 AND ADMINISTRATION
The dosage of MEXITIL (mexiletine hydrochloride, USP) must be individualized on the basis of response and tolerance, both of which are dose-related. Administration with food or antacid is recommended. Initiate MEXITIL (mexiletine hcl) 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 MEXITIL (mexiletine hcl) 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 MEXITIL (mexiletine hcl) . 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 (see PRECAUTIONS: DRUG INTERACTIONS).
When rapid control of ventricular arrhythmia is essential, an initial loading dose of 400 mg of MEXITIL (mexiletine hcl) 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 MEXITIL (mexiletine hcl) may be transferred to a 12-hour dosage schedule to improve convenience and compliance. If adequate suppression is achieved on a MEXITIL (mexiletine hcl) 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 Mexitil (mexiletine hcl)
The following dosage schedule, based on theoretical considerations rather than experimental data, is suggested for transferring patients from other Class I oral antiarrhythmic agents to MEXITIL (mexiletine hcl) : MEXITIL (mexiletine hcl) treatment may be initiated with a 200 mg dose, and titrated to response as described above, 6-12 hours after the last dose of quinidine sulfate, 3-6 hours after the last dose of procainamide, 6-12 hours after the last dose of disopyramide or 8-12 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 MEXITIL (mexiletine hcl) , the lidocaine infusion should be stopped when the first oral dose of MEXITIL (mexiletine hcl) 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 MEXITIL (mexiletine hcl) and the possibility that they may be additive.
MEXITIL (mexiletine hydrochloride, USP) is supplied in bottles of 100 hard gelatin capsules containing 150 mg, 200 mg or 250 mg of mexiletine hydrochloride:
MEXITIL (mexiletine hcl) 150 mg capsules are red and caramel with the marking Bl 66 (NDC 0597-0066-01).
MEXITIL (mexiletine hcl) 200 mg capsules are red with the marking Bl 67 (NDC 0597-0067-01).
MEXITIL (mexiletine hcl) 250 mg capsules are red and aqua green with the marking Bl 68 (NDC 0597-0068-01).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature].
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut 06877 USA. Rev: 05/30/03
Last reviewed on RxList: 4/8/2009
This monograph has been modified to include the generic and brand name in many instances.
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