INDICATION

UNITHROID is a prescription synthetic thyroid hormone that is used to treat a condition called hypothyroidism. It is intended to replace a hormone that is normally produced by your thyroid gland. Generally, thyroid replacement therapy is to be taken for life.

IMPORTANT SAFETY INFORMATION

WARNING:
Thyroid hormones, including UNITHROID, should not be used either alone or in combination with other medicines for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of UNITHROID within the typical range used for hormone replacement are not effective for weight loss. Larger doses may result in serious or even life‑threatening effects, especially when used in combination with certain other drugs used to reduce appetite.
  • Notify your physician if you are allergic to any foods or medicines, are pregnant or intend to become pregnant, are breast-feeding or are taking any other medications, including prescription and over‑the‑counter preparations.
  • Notify your physician of any other medical conditions you may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems. Your dose of medications used to control these other conditions may need to be adjusted while you are taking UNITHROID. If you have diabetes, monitor your blood and/or urinary glucose levels as directed by your physician and immediately report any changes to your physician. If you are taking anticoagulants (blood thinners), your clotting status should be checked frequently.
  • Use UNITHROID only as prescribed by your physician. Do not discontinue or change the amount you take, or how often you take it, unless directed to do so by your physician.
  • Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets. Therefore, levothyroxine sodium tablets should not be administered within 4 hours of these agents.
  • Take UNITHROID in the morning, preferably on an empty stomach, one‑half to one hour before any food is eaten. Levothyroxine absorption is increased on an empty stomach.
  • Notify your physician if you experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.
  • Notify your physician or dentist that you are taking UNITHROID prior to any surgery.
  • After a stable response has been established, it is important to have follow‑up laboratory tests done, as ordered by your healthcare provider, at least annually.
  • Notify your physician if you become pregnant while taking UNITHROID. It is likely that your dose of UNITHROID will need to be increased while you are pregnant.

This is the most important information to know about UNITHROID. For more information, talk with your healthcare provider.

Please click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).