Mexiletinedrug info
mexiletine hydrochloride 200 MG Oral Capsule
What it is used for
INDICATIONS & 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 5, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white or almost white crystalline powder, freely soluble in water, Methanol and sparingly soluble in Methylene Chloride. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is: C 11 H 17 NO. HCl M. W. 215.72 g/mole Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and partially pregelatinized maize starch. The capsule shell contains D & C Yellow #10, gelatin and titanium dioxide. The 150 mg and 250 mg also contain FD&C Blue #1, FD&C Red #40, The 150 mg and 200 mg also contain FD&C Yellow #6. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The product complies with USP Dissolution Test 2. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 5, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
See what it costs — price without insurance