Thank you for visiting Levothroid.com. The thyroid is a complicated and vital part of your body, and each individual's thyroid may act somewhat differently. For this reason, any decisions regarding the use of a thyroid treatment should be made after a consultation between you and your healthcare professional. If you think you may be suffering from a thyroid disease and have not seen a doctor or other qualified healthcare professional, you should get a professional evaluation as soon as possible.
While we make every effort to provide accurate, up-to-date, and useful information on Levothroid.com, this site is not intended as a substitute for a clinical evaluation or the advice of a qualified doctor or other healthcare professional.
Indications
Contraindications
Warnings
Information for Patients
Levothroid® (levothyroxine sodium tablets, USP) is a synthetic product containing the
hormone levothyroxine (T4). It is indicated for the treatment of
hypothyroidism as a replacement or supplemental
therapy in congenital or acquired hypothyroidism of any etiology,
except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include:
primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of
the thyroid gland, or from the effects of surgery, radiation, or drugs, or without the presence of goiter.
Levothroid is also indicated for pituitary TSH suppression in the treatment or prevention
of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS in full Prescribing Information)
including thyroid nodules (see WARNINGS and PRECAUTIONS in full Prescribing Information),
subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter
(see WARNINGS and PRECAUTIONS in full Prescribing Information) and, as an adjunct to surgery and
radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Levothroid is
available in 12 strengths ranging from 25 mcg through 300 mcg to allow for proper titration of thyroid function.1
This gives your doctor a range of options to prescribe the most precise dose for your particular needs.
Levothyroxine is contraindicated in patients with subclinical (suppressed serum TSH level with normal T3 and T4 levels)
or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is
contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate
an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids (see PRECAUTIONS in full
Prescribing Information). LEVOTHROID is contraindicated in patients with hypersensitivity
to any of the inactive ingredients in LEVOTHROID tablets (see DESCRIPTION, Inactive Ingredients in full
Prescribing Information).
Levothroid tablets should be used with caution in patients with cardiovascular disease, including hypertension.
The development of chest pain or other exacerbation of cardiovascular symptoms will require a decrease in dosage.
Thyroid hormone may increase symptoms of diabetes mellitus,
diabetes insipidus, or adrenal insufficiency.
Adjustment of treatment measures for these endocrinological diseases is necessary if thyroid hormone therapy
is added. If Levothroid is used in the treatment of myxedema coma, glucocorticoids should be administered.
Thyroid hormones, including LEVOTHROID, either alone or with other therapeutic agents,
should not be used for the treatment of obesity or for weight loss. In euthyroid patients,
doses within the range of daily hormonal requirements are ineffective for weight reduction.
Larger doses may produce serious or even life threatening manifestations of toxicity,
particularly when given in association with sympathomimetic amines such as those used for
their anorectic effects.
Levothyroxine sodium should not be used in the treatment of male or female infertility unless
this condition is associated with hypothyroidism. In patients with nontoxic diffuse goiter or
nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease,
levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due
to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS).
If the serum TSH level is not suppressed, LEVOTHROID should be used with caution in conjunction with
careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for
potential associated adverse cardiovascular signs and symptoms of hyperthyroidism.
Patients should be informed of the following information to aid in the safe and effective use of LEVOTHROID:
- 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 LEVOTHROID. 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 LEVOTHROID 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 LEVOTHROID 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 LEVOTHROID 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 LEVOTHROID. It is likely that your dose of LEVOTHROID will need to be increased while you are pregnant.
- Notify your physician or dentist that you are taking LEVOTHROID prior to any surgery.
- Partial hair loss may occur rarely during the first few months of LEVOTHROID therapy, but this is usually temporary.
- LEVOTHROID should not be used as a primary or adjunctive therapy in a weight control program.
- Keep LEVOTHROID out of the reach of children. Store LEVOTHROID away from heat, moisture, and light.
- Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets. Therefore, levothyroxine sodium tablets should not be administered within 4 hrs of these agents.
Levothroid is available by prescription only.
Please see full Prescribing Information.
Click here for more information on
1. Data on file, Forest Laboratories, Inc.