Mellaril

Unless your doctor tells you otherwise, continue your usual diet.

Thioridazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• blurred vision
• dry mouth
• nausea
• vomiting
• diarrhea
• constipation
• changes in appetite
• weight gain
• stuffed nose
• pale skin
• darkening of the skin or eyes
• swelling of the arms, hands, feet, ankles, or lower legs
• blank facial expression
• shuffling walk
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• unusual dreams
• breast milk production
• breast enlargement
• missed menstrual periods
• decreased sexual ability in men
• difficulty urinating

Some side effects may be serious. If you experience any of the following symptoms or the ones listed in the IMPORTANT WARNING section, call your doctor immediately:

• fever
• muscle stiffness
• confusion
• sweating
• neck cramps
• tightness in the throat
• difficulty breathing or swallowing
• tongue that sticks out of the mouth
• fine, worm-like tongue movements
• uncontrollable, rhythmic face, mouth, or jaw movements
• vision loss, especially at night
• seeing everything with a brown tint
• yellowing of the skin and eyes
• rash
• hives
• erection that lasts for hours

Thioridazine may cause other side effects. Call your doctor if you have any unusual problems while you are taking thioridazine.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Mechanism of Action

Piperazine phenothiazine agent; antagonist for the postsynaptic mesolimbic dopaminergic D2 receptors in the brain; decreases the release of hypothalamic and hypophyseal hormones

Pharmacokinetics

Half-Life elimination: 24 hr

Metabolism: Hepatic P450 enzyme CYP2D6

Enzymes inhibited: CYP2D6

Protein bound: 95%

Duration: 4-5 days

Serious side effects have been reported with Mellaril including the following:

• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking thioridazine. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:
  • feeling faint
  • lightheadedness
  • dizziness
  • feeling like your heart is beating irregularly or quickly
• Tardive Dyskinesia. This is a condition that causes the body to move involuntarily (twitching). It mostly tends to affect the mouth and lower part of the face. Tell your healthcare provider right away if you have any signs or symptoms of tardive dyskinesia:
  • finger movements or twitching
  • involuntary movements, or twitching of the mouth
  • constantly sticking out the tongue, or tongue thrusting
  • repetitive chewing
  • swinging of the jaw
• Neuroleptic Malignant Syndrome (NMS). NMS is a life-threatening condition that is can be caused by side effects to drugs that work in the brain. Tell your healthcare provider right away if you have any signs or symptoms of NMS:
  • high fevers
  • sweating
  • fluctuating blood pressure
  • confusion
  • having rigid or stiff muscles
• Low white blood cell count. Your white blood cells are responsible for protecting the body from infections. Tell your healthcare provider right away if you have any signs or symptoms of having a low white blood cell count:
  • Getting infections easily
  • Fever
  • Sore throat
  • Severe chills
• Seizures

Mellaril can cause drowsiness. Do not drive or operate heavy machinery until you know how Mellaril affects you.

Do not take Mellaril if you:

• are allergic to Mellaril or to any of its ingredients
• take drugs that can cause an arrhythmia called Torsades des Pointes
• take medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• take medications that severely reduce alertness, or are in a coma
• have very high blood pressure, or have very low blood pressure

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• The dose your doctor recommends may be based on the following:
• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The usual starting dose for Mellaril (thioridazine) is 50 mg to 100 mg 3 times a day. The maximum dose should be 200 mg 4 times a day, or 400 mg 2 times a day.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using thioridazine, you may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

If you need surgery, tell the surgeon ahead of time that you are using thioridazine.

Store at room temperature away from moisture, heat, and light.

Thioridazine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. Dangerous side effects could occur.

Applies to thioridazine: oral tablet

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Loose stools (diarrhea).
• Dry mouth.
• Feeling sleepy.
• Stuffy nose.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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