IMPORTANT SAFETY INFORMATION

Do not use UNITHROID alone or in combination with other drugs for the treatment of obesity or weight loss.

If your thyroid levels are normal, doses of UNITHROID 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 take UNITHROID if you have a problem with your adrenal gland that has not been corrected. Starting thyroid hormone therapy before initiating treatment for adrenal insufficiency may cause a life-threatening condition.

Do not take UNITHROID as the first therapy or additional therapy in a weight control program.

Too much levothyroxine may affect your heart, especially if you are elderly or have cardiovascular disease. When starting UNITHROID, contact your
healthcare provider immediately if you have any signs of increased heart rate, chest pain, or an irregular heartbeat.

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

Take UNITHROID exactly as prescribed.

Take UNITHROID as a single dose, preferably on an empty stomach, ½ to 1 hour before breakfast with a full glass of water to avoid choking or gagging.

Products such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine, so UNITHROID should be taken 4 hours before
or after taking these products.

It may take several weeks before you notice an improvement in symptoms. Once your healthcare provider has found your specific dose of UNITHROID,
it is important to have periodic lab tests and clinical evaluations to assess your response.

Treatment with thyroid hormone replacement will likely be lifelong.

Before taking UNITHROID, tell your healthcare provider if you:

have diabetes. UNITHROID may worsen control of blood sugar levels. After starting, stopping, or changing UNITHROID, closely monitor your blood sugar levels and
contact your healthcare provider if there are any abnormal changes.
are taking oral blood thinners. UNITHROID may increase your response to oral blood thinners.
are pregnant, plan to become pregnant or are breastfeeding. Your dose of UNITHROID may need to be adjusted if you become pregnant.
have any other medical conditions, particularly: heart disease, adrenal or pituitary gland problems, or depression.

Talk to your healthcare provider about:

all other medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Do not change or stop any of your medicines or
start any new medicines before you talk to your healthcare provider.
your diet. Certain foods such as soybean flour, cottonseed meal, walnuts, dietary fiber, and grapefruit juice may cause your body to absorb less levothyroxine and may
reduce its effect.
taking UNITHROID before any surgery.
hair loss. Partial hair loss may occur infrequently during the first few months of UNITHROID therapy which is usually temporary.

Tell your healthcare provider if you develop any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, muscle spasm, headache, nervousness, irritability, sleeplessness, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, changes in menstrual periods, skin rash or any other unusual medical event.

These are not all the possible side effects of UNITHROID. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about your health or medicines, including side effects. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

APPROVED USE FOR UNITHROID

UNITHROID® (levothyroxine sodium) tablets is an oral prescription medicine used:

To replace a hormone usually made by the thyroid gland in adults and children with hypothyroidism
Along with surgery and radioiodine therapy to manage a certain type of thyroid cancer

UNITHROID should not be used to treat noncancerous enlargement of the thyroid in patients with normal iodine levels, or temporary hypothyroidism
due to inflammation of the thyroid (thyroiditis).

Please see Full Prescribing Information.

REFERENCES:

Mount Sinai. Hypothyroidism. Accessed December 11, 2024. https://www.mountsinai.org/health-library/diseases-conditions/hypothyroidism
Cleveland Clinic. Hypothyroidism. Accessed December 11, 2024. https://my.clevelandclinic.org/health/diseases/12120-hypothyroidism
Mayo Clinic. Hypothyroidism: does it cause joint pain? Accessed December 11, 2024. https://www.mayoclinic.org/diseases-conditions/hypothyroidism/expert-answers/hypothyroidism/faq-20057789
Mateo RCI, Hennessey JV. Endocrine. 2019;66(1):10-17.
Data on file, Amneal Pharmaceuticals.
UNITHROID [package insert].
Mayo Clinic. Diseases and conditions: hypothyroidism (underactive thyroid). Accessed December 11, 2024 https://www.mayoclinic.org/diseases-conditions/hypothyroidism/symptoms-causes/syc-20350284
US Food and Drug Administration. Guidance for Industry: levothyroxine sodium products enforcement of August 14, 2001, compliance date and submission of new applications. Updated July 2001. Accessed December 11, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august-14-2001-compliance-date-and-submission-new
US Department of Health and Human Services. Orange Book: approved drugs with therapeutic equivalence evaluations, 44th ed. Published 2024. Accessed December 11, 2024. https://www.fda.gov/media/71474/download
Reker D, Blum SM, Steiger C, et al. Sci Transl Med. 2019;11(483):eaau6753.
Benvenga S, Carlé A. Adv Ther. 2019;36(Suppl 2):59-71.
Hennessey JV, Malabanan AO, Haugen BR, Levy EG. Endocr Pract. 2010;16:357-370.
American Thyroid Association. Hypothyroidism: a booklet for patients and their families. Accessed December 11, 2024. https://www.thyroid.org/wp-content/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf
Jonklaas J, Bianco AC, Bauer AJ, et al. Thyroid. 2014;24(12):1670-1751.