Mexiletine Hcl Recall
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FDA Labeling Changes
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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.
There is currently no drug history available for this drug.
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.