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 use iodine to make thyroid hormone. It does not block the effects of a thyroid hormone that was made by the body before its use was begun.

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.

Pregnancy—

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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:

• Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia)—Use with caution. May make these conditions worse.

• Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. 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. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Food in your stomach may change the amount of methimazole that is able to enter the bloodstream. To make sure that you always get the same effects, try to take methimazole at the same time in relation to meals every day. That is, always take it with meals or always take it on an empty stomach.

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 treatment of hyperthyroidism (overactive thyroid):
    • Adults—At first, 15 to 60 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is 5 to 15 mg daily.
    • 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 into 3 equal doses and given every 8 hours. The maintenance dose is 0.2 mg/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 progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Methimazole can temporarily lower the number of white blood cells in your blood, increasing 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.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

While you are being treated with methimazole, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methimazole may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking methimazole together with medicines used during surgery may increase the risk of side effects.

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:

More common

Black, tarry stools

chest pain

chills

cough

fever

painful or difficult urination

shortness of breath

sore throat

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

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Backache

increase or decrease in urination

swelling of the feet or lower legs

Incidence not known

Abdominal or stomach pain

bleeding gums

bleeding under the skin

blood in the urine or stools

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

cough or hoarseness

dark urine

difficulty with moving

fever with or without chills

general feeling of discomfort, illness, or weakness

general feeling of tiredness or weakness

headache

joint pain

light-colored stools

loss of appetite and weight

lower back or side pain

muscle aching or cramping

muscle pain or stiffness

nausea and vomiting

numbness or tingling of the hands, feet, or face

pinpoint red spots on the skin

soreness of the muscles

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

swollen joints

swollen salivary glands

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

tightness in the chest

upper right abdominal pain

wheezing

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Cloudy or bloody urine

cracks in the skin

high blood pressure

loss of heat from the body

red, swollen skin

scaly skin

sensation of pins and needles

stabbing pain

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

dizziness or lightheadedness

feeling of constant movement of self or surroundings

heartburn

hives or welts

itching

loss of taste

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

redness of the skin

sensation of spinning

skin rash

sleepiness

vomiting

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.