Pronunciation:

meth-IM-a-zole

Brand Names:

• Tapazole

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antithyroid Agent

Chemical—

Thionamide

Uses of This Medicine:

Methimazole is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment. Methimazole is an antithyroid medicine. It works by making it harder for the body to make thyroid hormone.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methimazole in children.

Older adults—

No information is available on the relationship of age to the effects of methimazole in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Levoketoconazole
• Methotrexate
• Tegafur

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Dicumarol
• Phenindione
• Phenprocoumon
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agranulocytosis (very low white blood cells) or
• Aplastic anemia (very low red blood cells) or
• Blood or bone marrow problems or
• Leukopenia (low white blood cells) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Breathing problems or
• Kidney disease or
• Liver disease or
• Lung disease—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine works best when there is a constant amount in the blood. Do not miss any doses. If you are taking more than one dose per day, it is best to take the doses at evenly spaced times. If you need help planning when to take your medicine, check with your doctor or pharmacist.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For hyperthyroidism:
    • Adults—At first, 15 to 60 milligrams (mg) per day, given in 3 divided doses about every 8 hours. The maintenance dose is 5 to 15 mg per day.
    • Children—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.4 mg per kilogram (kg) of body weight per day, divided in 3 equal doses and given about every 8 hours. The maintenance dose is 0.2 mg per kg of body weight per day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine during the first three months of your pregnancy can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

In very rare situations, methimazole can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause hypothyroidism (low levels of thyroid hormone in the blood). Check with your doctor right away if you have constipation, a depressed mood, dry skin and hair, feeling cold, hair loss hoarseness or husky voice, muscle cramps and stiffness, slowed heartbeat, weight gain, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools

bleeding gums

bleeding under the skin

bloody or cloudy urine

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

cough

dark urine

difficulty in breathing

dizziness or lightheadedness

drowsiness

feeling of constant movement of self or surroundings

fever

general feeling of discomfort, illness, or weakness

headache

hoarseness

itching, skin rash

light-colored stools

loss of appetite and weight

loss of consciousness

lower back or side pain

nausea

painful or difficult urination

pinpoint red spots on the skin

redness, soreness, or itching skin

sensation of spinning

sore throat

soreness of the muscles

sores, ulcers, or white spots on the lips or in the mouth

sores, welts, or blisters

stomach pain

swelling of the face, feet, or lower legs

swollen or painful glands

swollen salivary glands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain

upper right abdominal pain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Abnormal loss of hair

changes in skin coloring

difficulty in moving

heartburn

joint pain or swelling

loss of taste

muscle pain, cramps, or stiffness

pain or discomfort in the chest, upper stomach, or throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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