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:
  • Data on file. Amneal Pharmaceuticals LLC.
  • UNITHROID [package insert].
  • Mayo Clinic. Diseases and conditions: hypothyroidism (underactive thyroid). https://www.mayoclinic.org/diseases-conditions/hypothyroidism/symptoms-causes/syc-20350284. Accessed July 14, 2021.
  • US Food and Drug Administration. Guidance for Industry: levothyroxine sodium products enforcement of August 14, 2001, compliance date and submission of new applications. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august-14-2001-compliance-date-and-submission-new. Updated July 2001. Accessed July 14, 2021.
  • American Thyroid Association. General Information/Press Room. https://www.thyroid.org/media-main/press-room/. Accessed July 14, 2021.
  • Garber JR, Cobin RH, Gharib H, et al. Clinical Practice Guidelines for Hypothyroidism in Adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988-1028.
  • Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8(6):457-469.

UNITHROID IS AVAILABLE THROUGH TELEMEDICINE

We’ve partnered with Paloma Health, a virtual medical practice that treats patients with hypothyroidism and Hashimoto’s disease through telemedicine. Paloma Health connects patients with an independent, licensed doctor who specializes in the treatment of hypothyroidism and will prescribe UNITHROID if appropriate.

GET STARTED WITH TELEMEDICINE
House with trees in the background icon
SPECIALIZED, AT-HOME
HYPOTHYROID CARE*

Manage hypothyroidism from the comfort of your home with the convenience of at-home testing and telemedicine.

*As telemedicine regulations vary from state to state, Paloma Health
allows you to search for physicians who may practice in your state.

ELIGIBLE PATIENTS WITH COMMERCIAL INSURANCE CAN STILL PAY

$ 3

FOR A 30-DAY
PRESCRIPTION

Eligibility criteria and terms and conditions apply.

HOW WORKS

You can get your UNITHROID prescription from the comfort
of your home through telemedicine in 3 steps:

  • Box icon in front of a number 1
    ORDER LABS

    Collect your sample from the comfort of your home on your own schedule with an at-home complete thyroid test kit.

  • Doctor with stethoscope icon in front of a number 2
    SCHEDULE A VISIT

    Meet with a thyroid doctor via telemedicine for a deep dive on your thyroid health. A fee is associated with the visit and Paloma Health accepts many insurance plans.

  • Pill bottle icon in front of a number 3
    PICK UP YOUR PRESCRIPTION

    If a prescription is ordered, pick it up from your pharmacy or have it delivered to your home with UNITHROID At Your Door

Use the code UNITHROID to save up to 25% off the cost of an at-home complete thyroid test kit when you order through Paloma Health.