Mexitil

(Generic versions may still be available.)

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 (mexiletine hcl) has a pKa of 9.2.

Chemically, MEXITIL (mexiletine hcl) is 1-methyl-2-(2, 6-xylyloxy) ethylamine hydrochloride and has the following structural formula:

MEXITIL - mexiletine hydrochloride capsule  Structural Formula Illustration

MEXITIL (mexiletine hcl) 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 (mexiletine hcl) 150 mg and 250 mg capsules also contain FD&C Yellow No. 10 and D&C Red No. 28. MEXITIL (mexiletine hcl) capsules may contain one or more of the following components: sodium lauryl sulfate, lecithin, shellac, and FD&C Blue No. 1 Aluminum Lake.

What are the possible side effects of mexiletine (Mexitil)?

If you experience any of the following serious side effects, stop taking mexiletine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a new or a worsening irregular heartbeat pattern;
  • wheezing, coughing, chest pain, or chest discomfort;
  • unusual bruising or bleeding; or
  • fever, sore throat, a sore mouth, mouth ulcers, or an infection.

Other, less serious side effects...

Read All Potential Side Effects and See Pictures of Mexitil »

What are the precautions when taking mexiletine hcl (Mexitil)?

Before taking mexiletine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other heart problems (such as heart failure, slow heartbeat, previous heart attack), liver problems, seizure disorder.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly...

Read All Potential Precautions of Mexitil »


Mexitil Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, heartburn, dizziness, lightheadedness, vision problems (such as blurred vision), headache, shaking, nervousness, or problems with muscle control (coordination difficulties) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down), signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking mexiletine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other heart problems (such as heart failure, slow heartbeat, previous heart attack), liver problems, seizure disorder.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Mexitil Patient Information Including Side Effects

Brand Names: Mexitil

Generic Name: mexiletine (Pronunciation: mex IL e teen)

  • What is mexiletine (Mexitil)?
  • What are the possible side effects of mexiletine (Mexitil)?
  • What is the most important information I should know about mexiletine (Mexitil)?
  • What should I discuss with my healthcare provider before taking mexiletine (Mexitil)?
  • How should I take mexiletine (Mexitil)?
  • What happens if I miss a dose (Mexitil)?
  • What happens if I overdose (Mexitil)?
  • What should I avoid while taking mexiletine (Mexitil)?
  • What other drugs will affect mexiletine (Mexitil)?
  • Where can I get more information?

What is mexiletine (Mexitil)?

Mexiletine affects the way that your heart beats.

Mexiletine is used to treat seriously irregular heartbeats.

Mexiletine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of mexiletine (Mexitil)?

If you experience any of the following serious side effects, stop taking mexiletine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a new or a worsening irregular heartbeat pattern;
  • wheezing, coughing, chest pain, or chest discomfort;
  • unusual bruising or bleeding; or
  • fever, sore throat, a sore mouth, mouth ulcers, or an infection.

Other, less serious side effects may be more likely to occur. Continue to take mexiletine and talk to your doctor if you experience

  • dizziness, lightheadedness, or tiredness;
  • poor coordination;
  • dry mouth;
  • upset stomach, heartburn, vomiting, or decreased appetite;
  • diarrhea or constipation;
  • headache or blurred vision;
  • weakness;
  • numbness, tingling, or tremor (shaking);
  • ringing in your ears;
  • a rash; or
  • depression.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mexiletine (Mexitil)?

Do not skip doses, change your dosing schedule, or stop taking mexiletine without talking to your doctor. Changing your schedule could make your condition much worse.

Use caution when driving, operating machinery, or performing other hazardous activities. Mexiletine may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities.

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