USE: SYNTHROID® (levothyroxine sodium) tablets, USP

for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

IMPORTANT SAFETY INFORMATION

  • Thyroid hormones, including SYNTHROID, should not be used either alone or in combination with other drugs for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of SYNTHROID used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.

  • Do not use SYNTHROID if you have uncorrected adrenal problems.

  • Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.

  • Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.

  • Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less SYNTHROID from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of SYNTHROID may need to be adjusted.

  • Use SYNTHROID only as ordered by your doctor. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.

  • Products such as iron and calcium supplements and antacids can lower your body’s ability to absorb levothyroxine, so SYNTHROID should be taken 4 hours before or after taking these products.

  • Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID. Your dose of SYNTHROID may need to be increased during your pregnancy.

  • It may take several weeks before you notice an improvement in your symptoms.

  • Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.

  • Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.

  • Tell your doctor or dentist that you are taking SYNTHROID before any surgery.

  • Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.

  • Partial hair loss may occur during the first few months you are taking SYNTHROID.

This is the most important safety information you should know about SYNTHROID. For more information, talk with your doctor.

Click here for full Prescribing Information or go to http://www.rxabbvie.com/pdf/synthroid.pdf.

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.

If you cannot afford your medication, contact www.pparx.org for assistance.

YOU HAVE
QUESTIONS. WE
HAVE ANSWERS.

No matter how much you already know, you may still have many questions about hypothyroidism. This section gives you simple answers to commonly asked questions. It also provides helpful educational websites about hypothyroidism. Understanding hypothyroidism and getting answers to your questions are important steps to managing your condition.

VIDEO GALLERY

DR LEVY EXPLAINS HYPOTHYROIDISM AND WHAT CAUSES IT

Learn more about hypothyroidism, the causes, and who may be at risk for it.

FAQs

About

What is hypothyroidism?

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Hypothyroidism is when the thyroid doesn’t make enough of the thyroid hormone called thyroxine. What happens next? Different parts of the body can be affected by hypothyroidism, which can cause symptoms like tiredness, feeling cold, dry skin, and hair loss.

Did I do anything to cause my hypothyroidism?

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No. One of the most common causes of hypothyroidism is Hashimoto's disease, in which your own immune system attacks the thyroid gland by mistake. Other reasons people may develop hypothyroidism are surgery that removes all or part of the thyroid gland; radiation therapy in the head or neck; or radioactive iodine, used to treat an overactive thyroid (hyperthyroidism).

Who’s at risk for hypothyroidism?

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Hypothyroidism can affect anyone, but some people have a greater risk of developing it. Here are some risk factors for developing hypothyroidism:

  • Being a woman
  • Having a close relative with thyroid disease
  • Having an autoimmune disease such as type 1 diabetes or rheumatoid arthritis

The only way to know for sure if you have hypothyroidism is to see your doctor for a proper diagnosis.

Does hypothyroidism run in families?

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A family history of thyroid disease can increase your risk of developing thyroid disease.

What if I am pregnant or plan on becoming pregnant?

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It is extremely important that women who are pregnant or plan on becoming pregnant are evaluated for hypothyroidism, since hypothyroidism can affect the development of the baby. If hypothyroidism isn’t diagnosed and treated properly during pregnancy, it could lead to serious complications including miscarriage, low birth weight, and even stillbirth. Always notify your doctor if you are pregnant or intend to become pregnant.

What are the most common symptoms of hypothyroidism?

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There is a wide range of hypothyroidism symptoms. Many are physical symptoms, such as dry skin; hair loss swollen face, hands, legs, ankles, or feet; feeling cold; aches and pains in muscles or joints; hoarse or raspy voice; constipation; heavy menstrual bleeding or irregular periods; and fatigue.

There are other symptoms of hypothyroidism so if you have symptoms or notice anything unusual you should talk to your doctor.

What is TSH?

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TSH is short for thyroid-stimulating hormone. TSH is produced by a small gland in the brain called the pituitary, and can be measured by a blood test. The amount of TSH in the blood tells the doctor what the level of thyroid-stimulating hormone is in the body.

What is the right TSH level for me?

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If you have been diagnosed with hypothyroidism, the American Association of Clinical Endocrinologists and the American Thyroid Association recommend that TSH levels be between 0.45 and 4.12 mIU/L for people diagnosed with hypothyroidism. Your doctor will determine the appropriate level within that range for you. Remember, everyone is different.

What is a TSH test?

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A TSH test is used to check the level of TSH in the blood. If you have been diagnosed with hypothyroidism, the American Association of Clinical Endocrinologists and the American Thyroid Association recommend TSH levels be between 0.45 and 4.12 mIU/L for people diagnosed with hypothyroidism. Your doctor will determine the appropriate level within that range for you. Remember, everyone is different.

Is there a cure for hypothyroidism?

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No. Once low thyroid function is detected, your body will need help to maintain appropriate levels of thyroid hormone by taking a thyroid hormone replacement medication. Generally, thyroid replacement therapy is taken for life.

About Synthroid

What is Synthroid?

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SYNTHROID is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

How does Synthroid work?

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Synthroid replaces the thyroid hormone that your thyroid gland no longer makes enough of. Synthroid comes in 12 dosage strengths to allow your physician to prescribe just the right amount of medicine for you. You will need to work with your doctor to find the correct dose. This means office visits for lab tests, especially during the first months of treatment.

How often do I have to have my TSH levels checked when I start taking Synthroid?

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When you first start taking Synthroid, it’s very important for your doctor to monitor you closely. He or she will usually test your TSH levels every 6 to 8 weeks to make sure you’re on the right dose. Finding the right Synthroid dose for you may take some time. Keep in mind that everyone is unique.

ABOUT YOUR SYNTHROID ROUTINE

How do I take Synthroid?

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Take your Synthroid with water every morning when you wake up, on an empty stomach. Wait 30 minutes to 1 hour before breakfast. Make Synthroid part of your morning routine.

What should I do if I miss a dose of Synthroid?

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Call your doctor for advice on what you should do.

What are some possible side effects of Synthroid?

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Side effects can occur with Synthroid. Side effects of Synthroid may be caused by your body not getting enough medicine or getting too much medicine. Go to “Side Effects” on this website for more information.

When should I stop taking Synthroid?

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Missing your doses of Synthroid can affect your hormone levels. Do not stop taking Synthroid or change the way you take it unless instructed by your doctor.

ABOUT FOOD AND SUPPLEMENTS

Are there certain foods that can interfere with Synthroid?

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Yes, certain foods such as soy, fiber, cottonseed meal, walnuts and grapefruit juice can affect the absorption of Synthroid in your body. If you eat any of these on a regular basis, check with the doctor. They might have to adjust your dose of Synthroid.

Can I take Synthroid with my supplements and other medicines?

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Some dietary supplements and medications can interfere with the way Synthroid works. Some examples are iron supplements and multivitamins with iron, calcium supplements, and antacids. Take these specific supplements 4 hours before or after taking Synthroid.

Be sure to tell your doctor about all medications and supplements you are taking.

ABOUT DOSE CHANGES

Why does my doctor need to change my dose of Synthroid?

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Your dose of Synthroid may need to be adjusted for various reasons. In the beginning months of treatment, your dose might need to be changed a few times to get you to the dose that will keep your thyroid hormone thyroxine in balance. Throughout your lifetime, you might need dose adjustments because your thyroid function may change. For instance, if you become pregnant, your doctor may need to adjust your dose. This is why it is important to work with your doctor to monitor your thyroid hormone levels.

As I get older, will my Synthroid dose change?

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As people age, they might not need as much Synthroid to keep the thyroid hormone in balance. Because with aging, people might become more sensitive to medication and medications tend to clear from their systems more slowly. If you are elderly and are just starting treatment for hypothyroidism, the doctor may start you on a lower dose of medicine, check your TSH levels after 6 to 8 weeks, then adjust your dosage slowly until you’re at the dose your body needs.

I’m pregnant. Should I let my doctor know?

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Be sure to tell the doctor if you are pregnant or plan on becoming pregnant. To keep thyroid hormone levels in balance during pregnancy, you might need a different dose of levothyroxine (active ingredient in Synthroid).

About Cost

How much does Synthroid cost?

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Synthroid is affordable for many people and is covered by most insurance plans. There are many ways to save on Synthroid. One way is signing up for the Before Breakfast Club to receive Synthroid Coupons or the Synthroid Co-pay Card. (Eligibility restrictions apply. See co-pay card for details.)

ABOUT MAKING SURE YOU’RE GETTING THE SYNTHROID YOUR DOCTOR PRESCRIBED

How can I be sure I’m always getting the Synthroid my doctor prescribed?

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First, ask your pharmacist for Synthroid by name. Then check your Synthroid pill at every refill. After picking up your medicine at the pharmacy, check your Synthroid pill to make sure you’re getting the Synthroid you or your doctor prefers. And always look for the embossed name “SYNTHROID” on every pill. If it doesn’t have it, it’s not Synthroid.

The Food and Drug Administration has determined that certain levothyroxine products are interchangeable.
The FDA has determined that drugs that are classified as interchangeable can be substituted at the pharmacy. A levothyroxine product that is not interchangeable with Synthroid might not have the exact same effect on your TSH as Synthroid.

USE

SYNTHROID® (levothyroxine sodium) tablets, for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

IMPORTANT SAFETY INFORMATION

  • Thyroid hormones, including SYNTHROID, should not be used either alone or in combination with other drugs for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of SYNTHROID used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.

  • Do not use SYNTHROID if you have uncorrected adrenal problems.

  • Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.

  • Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.

  • Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less SYNTHROID from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of SYNTHROID may need to be adjusted.

  • Use SYNTHROID only as ordered by your doctor. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.

  • Products such as iron and calcium supplements and antacids can lower your body’s ability to absorb levothyroxine, so SYNTHROID should be taken 4 hours before or after taking these products.

  • Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID. Your dose of SYNTHROID may need to be increased during your pregnancy.

  • It may take several weeks before you notice an improvement in your symptoms.

  • Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.

  • Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.

  • Tell your doctor or dentist that you are taking SYNTHROID before any surgery.

  • Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.

  • Partial hair loss may occur during the first few months you are taking SYNTHROID.

This is the most important safety information you should know about SYNTHROID. For more information, talk with your doctor.

Click here for full Prescribing Information or go to http://www.rxabbvie.com/pdf/synthroid.pdf.

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.

If you cannot afford your medication, contact www.pparx.org for assistance.

SYNTHROID TABLETS ARE A PRESCRIPTION MEDICATION.