Liotrix

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.

IMPORTANT NOTICE:

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.

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.

Are there OTHER USES for this medicine?

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

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.

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 what herbal products you are taking, especially St. John's wort.

• 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 if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking liotrix, call your doctor.

• 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?

Liotrix may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• shaking hands that you cannot control
• headache
• insomnia
• anxiety
• depression
• muscle or joint pain
• weight gain
• nausea
• dry or itchy skin
• temporary hair loss, particularly in children during the first month of treatment

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• chest pain (angina)
• rapid or irregular heartbeat or pulse
• excessive sweating
• sensitivity to heat
• nervousness

Liotrix may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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.