Indication and Important Safety Information for Synthroid

Indication¹

Hypothyroidism
SYNTHROID^® (levothyroxine sodium) tablets, for oral use is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression
SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitation of Use¹

SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with SYNTHROID may induce hyperthyroidism.

SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Important Safety Information¹

WARNING:

• SYNTHROID is contraindicated in patients with uncorrected adrenal insufficiency.
• In the elderly and in patients with cardiovascular disease, SYNTHROID should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease. If cardiac symptoms develop or worsen, the SYNTHROID dose should be reduced or withheld for one week and restarted at a lower dose.
• Patients with coronary artery disease who are receiving SYNTHROID should be monitored closely during surgical procedures for cardiac arrhythmias. Monitor patients during concomitant administration of SYNTHROID and sympathomimetic agents for signs and symptoms of coronary insufficiency.
• Use of oral thyroid hormone is not recommended in myxedema coma. Products formulated for IV administration should be used to treat myxedema coma.
• Patients with adrenal insufficiency should be treated with replacement glucocorticoids prior to initiating treatment with SYNTHROID. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated.
• SYNTHROID has a narrow therapeutic index. Regardless of the indication for use, careful dosage titration is necessary to avoid the consequences of over- or under-treatment.
• Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing SYNTHROID.
• Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, patients receiving SYNTHROID should be given the minimum dose necessary that achieves the desired response.  
• Adverse reactions associated with SYNTHROID therapy are primarily those of hyperthyroidism due to therapeutic overdosage.
• Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to SYNTHROID. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with SYNTHROID.
• SYNTHROID should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and SYNTHROID dose adjusted as needed.

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