Mellaril

DRUG DESCRIPTION

Mellaril® (thioridazine HCl) is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine.

Mellaril® (thioridazine HCl) Structural Formula Illustration

10 mg, 15 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg Tablets

Active Ingredient: thioridazine HCl, USP

10 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

15 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Red #7, gelatin, lactose, methylparaben, povidone, propylparaben, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

25 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, synthetic iron oxide, talc, titanium dioxide, and other ingredients.

50 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin, lactose, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

100 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Yellow #6, lactose, methylparaben, povidone, propylparaben, sodium benzoate, sorbitol, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

150 mg Tablets

Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

200 mg Tablets

Inactive Ingredients: acacia, ammonium calcium alginate, calcium sulfate dihydrate, carnauba wax, colloidal silicon dioxide, D&C Red #7, lactose, magnesium stearate, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.

30 mg/mL and 100 mg/mL Oral Solution (Concentrate)

Active Ingredient: thioridazine HCl, USP

30 mg/mL Oral Solution (Concentrate)

Inactive Ingredients: alcohol, 3.0%, flavor, methylparaben, propylparaben, purified water, and sorbitol solution. May contain sodium hydroxide or hydrochloric acid to adjust the pH.

100 mg/mL Oral Solution (Concentrate)

Inactive Ingredients: alcohol, 4.2%, flavor, glycerin, methylparaben, propylparaben, purified water, sorbitol solution, and sucrose. May contain sodium hydroxide or hydrochloric acid to adjust pH.

5 mg/mL and 20 mg/mL Oral Suspension

Active Ingredient: each mL contains thioridazine, USP, equivalent to 5 mg and 20 mg thioridazine HCl, USP, respectively.

5 mg/mL Oral Suspension

Inactive Ingredients: carbomer 934, flavor, polysorbate 80, purified water, sodium hydroxide, and sucrose.

20 mg/mL Oral Suspension

Inactive Ingredients: carbomer 934, D&C Yellow #10, FD&C Yellow #6, flavor, polysorbate 80, purified water, sodium hydroxide, and sucrose.

What are the possible side effects of thioridazine (Mellaril, Mellaril-S)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using thioridazine and call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • ...

Read All Potential Side Effects and See Pictures of Mellaril »

What are the precautions when taking thioridazine hcl (Mellaril)?

Before taking thioridazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), severe blood pressure problems.

This medication should not be given to a patient that is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood problems (e.g., low white blood...

Read All Potential Precautions of Mellaril »


Mellaril Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, difficulty urinating, restlessness, headache, and blurred vision may occur. If any of these effects persist or worsen, notify 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 if any of these serious side effects occur: shakiness (tremors), muscle stiffness, mask-like facial expression, jerking movements while walking.

Thioridazine may rarely cause a condition known as tardive dyskinesia. In some cases this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, tongue, arms or legs).

In rare cases, thioridazine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), vision changes (e.g., vision loss, sudden difficulty seeing at night, brown-tinged vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following rare but very serious side effects: rapid breathing, muscle stiffness, high fever, increased sweating, fast heartbeat, sudden mental/mood changes.

A very serious allergic reaction to this drug is unlikely. Seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 thioridazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), severe blood pressure problems.

This medication should not be given to a patient that is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood problems (e.g., low white blood cell count), Parkinson's disease, history of seizures, low enzymes needed to remove drugs from the body (slow hydroxylator).

Thioridazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using thioridazine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using thioridazine safely.

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

To decrease dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness, difficulty urinating, and heart problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Mellaril Patient Information Including Side Effects

Brand Names: Mellaril, Mellaril-S

Generic Name: thioridazine (oral) (Pronunciation: THYE oh RID a zeen)

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

What is thioridazine (Mellaril)?

Thioridazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Thioridazine is used to treat psychotic disorders such as schizophrenia.

Thioridazine is usually given after other medications have been tried without successful treatment of schizophrenia.

Thioridazine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of thioridazine (Mellaril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using thioridazine and call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • feeling like you might pass out;
  • seizure (convulsions);
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • urinating less than usual or not at all;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • dry mouth, stuffy nose, constipation;
  • blurred vision, headache;
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm;
  • increased or decreased interest in sex;
  • sleep problems (insomnia), strange dreams; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about thioridazine (Mellaril)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Thioridazine is not for use in psychotic conditions related to dementia. Thioridazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not use thioridazine if you have brain damage, bone marrow depression, severe heart disease, a heart rhythm disorder, a history of "Long QT syndrome," or if you are also using large amounts of alcohol or medicines that make you sleepy.

Do not take thioridazine together with large amounts of alcohol or medicines that make you sleepy, or with medications that can affect heart rhythm. There are many medicines that should not be taken together with thioridazine because they may cause serious medical problems. Before taking thioridazine, tell your doctor about all other medications you use.

Before you take thioridazine, tell your doctor if you have heart disease, high blood pressure, a heart rhythm disorder, low levels of calcium or potassium in your blood, past or present breast cancer, liver or kidney disease, severe asthma or breathing problems, a history of seizures, Parkinson's disease, adrenal gland tumor, enlarged prostate or urination problems, glaucoma, or if you have ever had a serious side effect while using thioridazine or a similar medication.

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