TEVA-MEXILETINE 200 MG

What is TEVA-MEXILETINE?

TEVA-MEXILETINE 200 MG contains MEXILETINE HYDROCHLORIDE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02230360, held by TEVA CANADA LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 21-Jul-2016. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TEVA-MEXILETINE used for?

TEVA-MEXILETINE (mexiletine hydrochloride) is indicated for: • the treatment of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. • the treatment of patients with documented symptomatic ventricular arrhythmias when the symptoms are of sufficient severity to require treatment. Because of the proarrhythmic effects of mexiletine, its use should be reserved for patients in whom, in the opinion of the physician, the benefit of treatment clearly outweighs the risks.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The optimal dosage should be determined individually based on the patient's response and tolerance. The suggested initial dose is 200 mg 3 times daily. This can be raised to a maximum of 1200 mg daily, given in 3 or 4 divided doses. Titration of dose should occur in steps of 100 mg 3 times daily. At least 3 days are needed between each dosage change. The dose usually producing therapeutic response is between 600–900 mg daily. A small proportion of patients and those with severe liver disease may require lower doses such as 100 mg 3–4 times daily, since these doses have been shown to produce effective plasma levels in some patients. In patients in whom rapid control of ventricular arrhythmia is needed, a loading dose of 400 mg may be given. This should be followed by 200 mg administered 3 times daily, beginning 8 hours after the administration of the loading dose. Mexiletine should be taken with ample liquid, food and/or an antacid. For patients with sustained ventricular tachycardia, mexiletine therapy should be initiated in the hospital. Hospitalization may also be required for certain other patients depending on their cardiac status and underlying cardiac disease. If patient misses a dose, it should be taken immediately unless the time is close to the next dose. In such an event, patient should wait for next scheduled dose and continue on the regular schedule. A double dose should not be taken to make up for a missed dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Bottles should be stored between 15°-30°C. Keep out of reach and sight of children.

How is it supplied?

100 mg – White powder in opaque scarlet cap and opaque orange body, size #2 hard gelatin capsules with 'N' imprinted in white on the cap and '100' on the body. Available in bottles of 100. 200 mg – White powder in opaque scarlet cap and opaque scarlet body, size #1 hard gelatin capsules with 'N' imprinted in white on the cap and '200' on the body. Available in bottles of 100.

Contraindications

TEVA-MEXILETINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Hypersensitive to local anesthetics of amide type (e.g. lidocaine) Second or third degree Atrioventricular block (AV block) in the absence of a pacemaker Cardiogenic shock

Warnings and precautions

Mortality: No antiarrhythmic drug has been shown to reduce the incidence of sudden death in patients with asymptomatic ventricular arrhythmias. Most antiarrhythmic drugs have the potential to cause dangerous arrhythmias; some have been shown to be associated with an increased incidence of sudden death. In light of the above, physicians should carefully consider the risks and benefits of antiarrhythmic therapy for all patients with ventricular arrhythmias. Acute liver Injury: Abnormalities of the liver function and rare instances of severe liver injury, including hepatic necrosis have been reported in association with mexiletine treatment. Atrioventricular (AV) Block: If a ventricular pacemaker is operative, patients with second or third degree AV block may be treated with TEVA–MEXILETINE if continuously monitored. Caution should be exercised when TEVA–MEXILETINE is used in patients with first degree AV block. Congestive Heart Failure or Hypotension: TEVA–MEXILETINE (mexiletine hydrochloride) should be used cautiously in patients with hypotension or congestive heart failure because of its potential for depressing myocardial contractility. Proarrhythmic Effects: Mexiletine has been reported to aggravate or induce arrhythmias in some patients. In the 398 patients studied in North American controlled clinical trials in whom evaluation was possible, mexiletine induced or aggravated pre-existing arrhythmias in 3.8%. The incidence as reported in the literature has ranged from 8 to 29%. Sinus Node Dysfunction: Caution should be exercised when TEVA-MEXILETINE is used in patients with pre-existing sinus node dysfunction (e.g., sick sinus syndrome).

What can be used instead?

Other Canadian products sharing ATC code C01BB02 MEXILETINE. 4 of 8 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.