Brand Name(s):

• Thyrolar®

Other Name(s):

• T3/T4Liotrix

IMPORTANT WARNING:

Statement from Forest Laboratories Re: Availability of Thyrolar:

[Posted 5/18/2012] U.S. Pharmacopeia, an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States, has mandated new specifications for a component used in the manufacturing of Thyrolar. As a result, all strengths of Thyrolar are currently on long-term back order while Forest makes the modifications necessary to meet these new specifications.

Forest is working diligently to complete these modifications. In the meantime, patients should speak with their physician regarding appropriate treatment for their condition, and check for future updates on the availability of Thyrolar through the Forest product availability toll-free hotline at(866) 927-3260.

IMPORTANT WARNING

Thyroid hormones should not be used to treat obesity in patients with normal thyroid function. Liotrix is ineffective for weight reduction in normal thyroid patients and may cause serious or life-threatening toxicity, especially when taken with amphetamines such as benzphetamine (Didrex), dextroamphetamine (Dexedrine, in Adderall), methamphetamine (Desoxyn). Talk to your doctor about the potential risks associated with this medication.

WHY is this medicine prescribed?

Liotrix is used to treat hypothyroidism (a condition that results when the thyroid gland does not produce enough thyroid hormone). Symptoms of hypothyroidism include lack of energy, depression, constipation, weight gain, hair loss, dry skin, dry coarse hair, muscle cramps, decreased concentration, aches and pains, swelling of the legs, and increased sensitivity to cold. When taken correctly, liotrix can reverse these symptoms. Liotrix is also used to treat goiter (enlarged thyroid gland). This medication is also used to test for hyperthyroidism (a condition where the thyroid gland produces too much thyroid hormone). Liotrix is in a class of medications called thyroid agents. It works by supplying the thyroid hormones normally produced by the body.

HOW should this medicine be used?

Liotrix comes as a tablet to take by mouth. It is usually taken once a day before breakfast or the first food of the day. Take liotrix at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take liotrix exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of liotrix and gradually increase your dose not more than once every 2 to 3 weeks.

Liotrix controls hypothyroidism but does not cure it. It may take several weeks before you feel the full benefit of liotrix. Continue to take liotrix even if you feel well. Do not stop taking liotrix without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking liotrix,

• tell your doctor and pharmacist if you are allergic to liothyronine, levothyroxine, thyroid hormone, any other medications, or any of the ingredients in liotrix. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: androgens such as danazol or testosterone; anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants; carbamazepine (Carbatrol, Epitol, Tegretol); diabetes medications that you take by mouth; digoxin (Lanoxin); estrogen (hormone replacement therapy); insulin; oral contraceptives containing estrogen; oral steroids such as dexamethasone (Decadron, Dexone, Dexpak); methylprednisolone (Medrol) and prednisone (Deltasone); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin, Phenytek); potassium iodide (contained in Elixophyllin-Kl, Pediacof, KIE); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); salicylate pain relievers such as aspirin and aspirin-containing products, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); and strong iodine solution (Lugol's Solution).
• if you take cholestyramine (Questran) or colestipol (Colestid), take it at least 4 hours before or after taking your thyroid medication. If you take antacids, iron-containing medications or nutritional supplements, simethicone, or sucralfate (Carafate), take them at least 4 hours before or after taking your thyroid medication.
• tell your doctor if you have or have ever had diabetes; osteoporosis; hardening or narrowing of the arteries (atherosclerosis); cardiovascular disease such as high blood pressure, high blood cholesterol and fats, angina (chest pain), arrhythmias, or heart attack; malabsorption diseases (conditions that cause a decrease in absorption from the intestine); an underactive adrenal or pituitary gland; or kidney or liver disease.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking liotrix, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking liotrix.
• you should know that if you have diabetes mellitus and begin taking liotrix, your daily requirement of insulin or oral medication may need to be adjusted. Monitor your blood sugar levels carefully and tell your doctor if you notice any changes.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed and out of reach of children. Store the tablets in the refrigerator. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to liotrix.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking liotrix.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 17, 2011.