( 5.6)įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 General Administration Information 2.2 General Principles of Dosing 2.3 Dosing in Specific Patient Populations 2.4 Monitoring TSH and/or Thyroxine (T4) Levels 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease 5.2 Myxedema Coma 5.3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency 5.4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism 5.5 Worsening of Diabetic Control 5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics 7.2 Antidiabetic Therapy 7.3 Oral Anticoagulants 7.4 Digitalis Glycosides 7.5 Antidepressant Therapy 7.6 Ketamine 7.7 Sympathomimetics 7.8 Tyrosine-Kinase Inhibitors 7.9 Drug-Food Interactions 7.10 Drug-Laboratory Test Interactions 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.Īdminister levothyroxine sodium tablets as a single daily dose, on an empty stomach, one-half to one hour before breakfast.Īdminister levothyroxine sodium tablets at least 4 hours before or after drugs known to interfere with levothyroxine sodium tablets absorption. Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density.Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements.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.Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of levothyroxine sodium tablets treatment.Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate levothyroxine sodium tablets at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
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