Product Description.:
N 739, 150
capsule , peach tan , oblong oblong
Black ink
MEXITIL
(mexiletine hydrochloride) Capsule
Capsules of 150 mg, 200 mg and 250 mg
Oral Antiarrhythmic
DRUG DESCRIPTION
MEXITIL? (mexiletine hydrochloride, USP) 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. MEXITIL has a pKa of 9.2.
MEXITIL capsules contain the following excipients: colloidal silicon dioxide, corn starch, magnesium stearate, titanium dioxide, gelatin, pharmaceutical glaze, simethicone, FD&C Red No. 40, and FD&C Blue No. 1 the MEXITIL 150 mg and 250 mg capsules also contain FD&C Yellow No. 10 and D&C Red No. 28. MEXITIL capsules may contain one or more of the following components: sodium lauryl sulfate, lecithin, shellac, and FD&C Blue No. 1 Aluminum Lake.
INDICATIONS
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, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of MEXITIL 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.
SIDE EFFECTS
MEXITIL (mexiletine hydrochloride, USP) commonly produces reversible gastrointestinal and nervous system adverse reactions but is otherwise well tolerated. MEXITIL 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 600-1200 mg/day some patients (8%) in the compassionate use program were treated with higher daily doses (1600-3200 mg/day). In the three-month controlled trials comparing MEXITIL 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.
