Tirosint-SOL Important Safety Information
IMPORTANT SAFETY INFORMATION for TIROSINT-SOL (levothyroxine sodium) ORAL SOLUTION
WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including TIROSINT-SOL, 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.
Contraindications
- Hypersensitivity to glycerol
- Uncorrected adrenal insufficiency
Warnings and Precautions
- Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation
- Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma
- Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT-SOL treatment
- Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism
- Worsening of diabetic control: 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 thyroid hormone therapy
- Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose
Limitations of Use
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
- Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis
Adverse Reactions
Adverse reactions associated with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash
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