Drugs Details

Drugs Info of Tapazole
Drugs Details
  • Drugs Type  : FDA
  • Date : 17th Jun 2015 04:14 am
  • Brand Name : Tapazole
  • Generic Name : (methimazole) Tablets, USP
Descriptions

TAPAZOLE® (methimazole) Tablets, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5-instead of a 6-membered ring.

Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug.

Each tablet also contains lactose monohydrate, magnesium stearate, starch (corn), pregelatinized starch and talc.

The molecular weight is 114.16, and the molecular formula is C4H6N2S. The structural formula is as follows:

 

TAPAZOLE® (Methimazole) Structural Formula Illustration

What are the possible side effects of methimazole (Northyx, Tapazole)?

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

  • fever, chills, sore throat, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • blood in your urine or stools;
  • severe blistering, peeling, and red skin rash; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice...

Read All Potential Side Effects and See Pictures of Tapazole »

What are the precautions when taking methimazole (Tapazole)?

Before taking methimazole, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as agranulocytosis, thrombocytopenia), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during the first 3 months of pregnancy. It should be used only when clearly needed during the last 6 months of pregnancy. Discuss the...

This monograph has been modified to include the generic and brand name in many instances.

Indications

TAPAZOLE is indicated:

  • In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option.
  • To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.

Dosage Administration

TAPAZOLE is administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals.

Adult -The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 to 15 mg daily.

Pediatric -Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.

How Supplied

TAPAZOLE Tablets are available in:

The 5-mg tablets are round, white to off-white, scored on one side and the other side debossed with “J94”.

They are available as follows:

Bottles of 100 NDC 60793-104-01

The 10-mg tablets are round, white to off-white, scored on one side and the other side debossed with “J95”.

They are available as follows:

Bottles of 100 NDC 60793-105-01

Store at controlled room temperature, 15° to 30°C (59° to 86°F).

Distributed by: King Pharmaceuticals, Inc. Bristol, TN 37620. Manufactured by: AAI Pharma, 1726 North 23rd St., Wilmington, NC 28405. Revised February 2012


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoieses (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely.

Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy.

Read the Tapazole (methimazole) Side Effects Center for a complete guide to possible side effects

Interactions

Anticoagulants (oral)

Due to potential inhibition of vitamin K activity by methimazole, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures.

β-adrenergic blocking agents

Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.

Digitalis glycosides

Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be needed.

Theophylline

Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Congenital Malformations

Methimazole readily crosses the placental membranes and can cause fetal harm, particularly when administered in the first trimester of pregnancy. Rare instances of congenital defects, including aplasia cutis, craniofacial malformations (facial dysmorphism; choanal atresia) and gastrointestinal malformations (esophageal atresia with or without tracheoesophageal fistula; umbilical abnormalities) have occurred in infants born to mothers who received TAPAZOLE during pregnancy. If TAPAZOLE is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus.

Since the above congenital defects have been reported in offspring of patients treated with TAPAZOLE, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism, particularly during organogenesis, in the first trimester of pregnancy. If TAPAZOLE is used, the lowest possible dose to control the maternal disease should be given.

Agranulocytosis

Agranulocytosis is potentially a life-threatening adverse reaction of TAPAZOLE therapy. Patients should be instructed to immediately report to their physicians any symptoms suggestive of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, or exfoliative dermatitis and the patient's bone marrow indices should be monitored.

Liver Toxicity

Although there have been reports of hepatotoxicity (including acute liver failure) associated with TAPAZOLE, the risk of hepatotoxicity appears to be less with methimazole than with propylthiouracil, especially in the pediatric population. Symptoms suggestive of hepatic dysfunction (anorexia, pruritis, right upper quadrant pain, etc.) should prompt evaluation of liver function (bilirubin, alkaline phosphatase) and hepatocellur integrity (ALT, AST). Drug treatment should be discontinued promptly in the event of clinically significant evidence of liver abnormality including hepatic transaminase values exceeding 3 times the upper limit of normal.

Hypothyroidism

TAPAZOLE can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, methimazole can cause fetal goiter and cretinism when administered to a pregnant woman. For this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy (see PRECAUTIONS, Pregnancy).

Precautions

General

Patients who receive methimazole should be under close surveillance and should be cautioned to report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. In such cases, white-blood-cell and differential counts should be obtained to determine whether agranulocytosis has developed. Particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.

Laboratory Tests

Because methimazole may cause hypoprothrombinemia and bleeding, prothrombin time should be monitored during therapy with the drug, especially before surgical procedures. Thyroid function tests should be monitored periodically during therapy. Once clinical evidence of hyperthyroidism has resolved, the finding of a rising serum TSH indicates that a lower maintenance dose of TAPAZOLE should be employed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2 year study, rats were given methimazole at doses of 0.5, 3, and 18 mg/kg/day. These doses were 0.3, 2, and 12 times the 15 mg/day maximum human maintenance dose (when calculated on the basis of surface area). Thyroid hyperplasia, adenoma, and carcinoma developed in rats at the two higher doses. The clinical significance of these findings is unclear.

Pregnancy

Pregnancy Category D

Due to the rare occurrence of congenital malformations associated with methimazole use, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism particularly in the first trimester of pregnancy (during organogenesis).

Patients should be advised that if they become pregnant or intend to become pregnant while taking an antithyoid drug, they should contact their physician immediately about their therapy.

In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently, a reduction in dosage of anti-thyroid therapy may be possible. In some instances, use of anti-thyroid therapy can be discontinues 2 or 3 weeks before delivery. Because the drug readily crosses placental membranes, methimazole can cause fetal goiter and cretinism when administered to a pregnant woman. For this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy (see WARNINGS).

Nursing Mothers

Methimazole is excreted into breast milk. However, several studies found no effect on clinical status in nursing infants of mothers taking methimazole, particularly if thyroid function is monitored at frequent (weekly or biweekly) intervals. A long-term study of 139 thyrotoxic lactating mothers and their infants failed to demonstrate toxicity in infants who are nursed by mothers receiving treatment with methimazole.

Pediatric Use

Because of postmarketing reports of severe liver injury in pediatric patient treated with propylthiouracil, TAPAZOLE is the preferred choice when an antithyroid drug is required for a pediatric patient (see DOSAGE AND ADMINISTRATION).


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Signs and Symptoms

Symptoms may include nausea, vomiting, epigastric distress, headache, fever, joint pain, pruritus, and edema. Aplastic anemia (pancytopenia) or agranulocytosis may be manifested in hours to days. Less frequent events are hepatitis, nephrotic syndrome, exfoliative dermatitis, neuropathies, and CNS stimulation or depression. No information is available on the median lethal dose of the drug or the concentration of methimazole in biologic fluids associated with toxicity and/or death.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's medical status.

ContrainDications

TAPAZOLE is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Methimazole inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. The drug does not inactivate existing thyroxine and tri-iodothyronine that are stored in the thyroid or circulating in the blood nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection.

Methimazole is readily absorbed in the gastrointestinal tract, metabolized in the liver, and excreted in the urine.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

METHIMAZOLE - ORAL

 

(meh-THIM-uh-zole)

 

COMMON BRAND NAME(S): Tapazole

 

USES: Methimazole is used to treat overactive thyroid (hyperthyroidism). It works by stopping the thyroid gland from making too much thyroid hormone.

 

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day (every 8 hours).

Dosage is based on your medical condition and response to treatment. For children, the dosage is also based on their weight.

Take this medication exactly as directed. Do not increase your dose or take it more often than prescribed. Your condition will not improve faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Stomach upset, nausea, vomiting, or mild rash/itching may occur. If any of these effects persist or worsen, tell 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 immediately if any of these rare but serious side effects occur: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting, joint/muscle pain, change in the amount of urine.

This medication may rarely cause very serious blood disorders (such as a low number of red cells, white cells, and platelets), especially during the first few months of treatment. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

 

Read the Tapazole (methimazole) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking methimazole, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as agranulocytosis, thrombocytopenia), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during the first 3 months of pregnancy. It should be used only when clearly needed during the last 6 months of pregnancy. Discuss the risks and benefits with your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), digoxin, theophylline.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood counts, liver/thyroid function tests, prothrombin time) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Storage temperature ranges differ according to different manufacturers, so consult your pharmacist for more information. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Northyx, Tapazole

Generic Name: methimazole (Pronunciation: me THIM a zole)

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

What is methimazole (Tapazole)?

Methimazole prevents the thyroid gland from producing too much thyroid hormone.

Methimazole is used to treat hyperthyroidism (overactive thyroid). It is also used before thyroid surgery or radioactive iodine treatment.

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

Methimazole 10 mg-EON

round, white, imprinted with E 210

What are the possible side effects of methimazole (Tapazole)?

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

  • fever, chills, sore throat, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • blood in your urine or stools;
  • severe blistering, peeling, and red skin rash; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, drowsiness, dizziness;
  • mild nausea, vomiting, or stomach upset;
  • itching, minor skin rash;
  • muscle, joint, or nerve pain;
  • swelling; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tapazole (methimazole) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about methimazole (Tapazole)?

Do not use methimazole if you are pregnant. It could harm the unborn baby.

Do not take methimazole if you are breast-feeding a baby.

Methimazole can increase your risk of bleeding. If you need to have surgery, tell the surgeon ahead of time that you are using this medication.

Methimazole can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Do not receive a "live" vaccine while you are being treated with methimazole, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Keep using this medication even if you feel fine or have no symptoms of hyperthyroidism. You may need to keep taking methimazole long term to control your condition. Stopping the medication could cause your symptoms to return.

Side Effects Centers
  • Tapazole

Patient Detailed How Take

What should I discuss with my healthcare provider before taking methimazole (Tapazole)?

Do not use this medication if you are allergic to methimazole.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

  • liver disease;
  • a blood cell disorder; or
  • a weak immune system.

FDA pregnancy category D. Do not use methimazole if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Methimazole can pass into breast milk and may harm a nursing baby. Do not use methimazole if you are breast-feeding a baby.

How should I take methimazole (Tapazole)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take methimazole with a full glass of water.

Methimazole can be taken with or without food, but you should take it the same way each time.

Methimazole can increase your risk of bleeding. If you need to have any type of surgery, tell the surgeon ahead of time that you are using this medication.

Methimazole can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

It is important to use methimazole regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Keep using this medication even if you feel fine or have no symptoms of hyperthyroidism. You may need to keep taking methimazole long term to control your condition. Stopping the medication could cause your symptoms to return.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Tapazole

Patient Detailed Avoid Taking

What happens if I miss a dose (Tapazole)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Tapazole)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, upset stomach, headache, joint pain, fever, itching, swelling, or pale skin and easy bruising or bleeding.

What should I avoid while taking methimazole (Tapazole)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using methimazole, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What other drugs will affect methimazole (Tapazole)?

Tell your doctor about all other medicines you use, especially:

  • theophylline (Theo-Dur, Elixophyllin, Uniphyl, and others);
  • a blood thinner such as warfarin (Coumadin);
  • digoxin (digitalis, Lanoxin); or
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with methimazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about methimazole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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