Thioridazine oral concentrate

What is this medication?

THIORIDAZINE (thye oh RID a zeen) is used to treat schizophrenia. This medicine should only be used when other medications have not worked, because it can cause serious heart-related side effects.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mellaril, Mellaril Concentrate

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blockage in your bowel
• brain tumor
• dementia
• diabetes
• difficulty swallowing
• glaucoma
• have trouble controlling your muscles
• head injury
• heart disease
• history of irregular heartbeat
• if you often drink alcohol
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• low blood pressure
• lung or breathing disease, like asthma
• Parkinson's disease
• prostate disease
• seizures
• trouble passing urine
• an unusual or allergic reaction to thioridazine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked dropper to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. Mix the oral concentrate with half a glass (4 fluid ounces) of water, orange, or grapefruit juice. Do not mix with any drink containing caffeine (coffee, cola), tea, or apple juice. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• berotralstat
• certain medicines for irregular heart beat like amiodarone, dofetilide, dronedarone, encainide, flecainide, propafenone, quinidine
• cisapride
• fluoxetine
• fluvoxamine
• gefitinib
• metoclopramide
• other medicines that prolong the QT interval (an abnormal heart rhythm) like dacomitinib, degarelix, encorafenib, entrectinib, eribulin, goserelin, lapatinib
• paroxetine
• pimozide
• pindolol
• propranolol
• saquinavir
• viloxazine

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough, and cold
• atropine
• certain medicines for anxiety or sleep
• certain medicines for bladder problems like oxybutynin, tolterodine
• certain medicines for depression
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• certain medicines for travel sickness like scopolamine
• epinephrine
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• ipratropium
• levodopa or other medicines for Parkinson's disease
• lithium
• medicines for blood pressure
• medicines for seizures like phenobarbital, primidone, phenytoin
• medicines that relax muscles for surgery
• narcotic medicines for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase possible dizziness or drowsiness. Avoid alcoholic drinks.

This drug can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your health care provider right away.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• abnormal production of milk
• breast enlargement in both males and females
• changes in vision
• chest pain
• confusion
• fast, irregular heartbeat
• fever, chills, sore throat
• seizures
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• trouble passing urine or change in the amount of urine
• trouble swallowing
• uncontrollable movements of the arms, face, head, mouth, neck, or upper body
• unusual bruising or bleeding
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• drowsiness
• dry mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature below 30 degrees C (86 degrees F). Do not freeze. Protect from light. Dilute immediately before use, and do not store diluted solution. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, pour the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.