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.