"The US Food and Drug Administration (FDA) has approved calcifediol (Rayaldee, Opko Health, Inc) for the treatment of adults with secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency (serum total 25-hydroxyvitamin D "...
Patients should be informed of the following information to aid in the safe and effective use of NOVOTHYROX (levothyroxine sodium tablets) :
- 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 NOVOTHYROX (levothyroxine sodium tablets) . 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 NOVOTHYROX (levothyroxine sodium tablets) 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.
- The levothyroxine in NOVOTHYROX (levothyroxine sodium tablets) is intended to replace a hormone that is normally produced by your thyroid gland. Generally, replacement therapy is to be taken for life, except in cases of transient hypothyroidism, which is usually associated with an inflammation of the thyroid gland (thyroiditis).
- Take NOVOTHYROX (levothyroxine sodium tablets) as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. Levothyroxine absorption is increased on an empty stomach.
- It may take several weeks before you notice an improvement in your symptoms.
- 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 if you become pregnant while taking NOVOTHYROX (levothyroxine sodium tablets) . It is likely that your dose of NOVOTHYROX (levothyroxine sodium tablets) will need to be increased while you are pregnant.
- Notify your physician or dentist that you are taking NOVOTHYROX (levothyroxine sodium tablets) prior to any surgery.
- Partial hair loss may occur rarely during the first few months of NOVOTHYROX (levothyroxine sodium tablets) therapy, but this is usually temporary.
- NOVOTHYROX (levothyroxine sodium tablets) should not be used as a primary or adjunctive therapy in a weight control program.
- Keep NOVOTHYROX (levothyroxine sodium tablets) out of the reach of children. Store NOVOTHYROX (levothyroxine sodium tablets) away from heat, moisture, and light.
- Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine tablets. Therefore, levothyroxine sodium tablets should not be administered within 4 hours of these agents.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Novothyrox Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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