Levothyroxine Sodium
FULL PRESCRIBING INFORMATION: CONTENTS*
- LEVOTHYROXINE SODIUM DESCRIPTION
- INACTIVE INGREDIENT
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- INDICATIONS & USAGE
- LEVOTHYROXINE SODIUM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- LEVOTHYROXINE SODIUM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
LEVOTHYROXINE SODIUM DESCRIPTION
INACTIVE INGREDIENT
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE, PRECAUTIONSDOSAGE AND ADMINISTRATION
PHARMACOKINETICS
PRECAUTIONS, Drug InteractionsDrug-Food InteractionsPRECAUTIONS, Drug InteractionsDrug-Laboratory Test InteractionsPRECAUTIONS, Pregnancy
Table 1
Table 1: Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients
INDICATIONS & USAGE
WARNINGSPRECAUTIONSWARNINGSPRECAUTIONSWARNINGSPRECAUTIONS
LEVOTHYROXINE SODIUM CONTRAINDICATIONS
PRECAUTIONSDESCRIPTION, Inactive IngredientsWARNINGS
WARNINGSCONTRAINDICATIONS
PRECAUTIONS
GeneralDrug Interactions
WARNINGSPRECAUTIONS, Geriatric Use, andDOSAGE AND ADMINISTRATION). If cardiac symptoms develop or worsen, the levothyroxine dose should be reduced or withheld for one week and then cautiously restarted at a lower dose. Overtreatment with levothyroxine sodium may have adverse cardiovascular effects such as an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias. Patients with coronary artery disease who are receiving levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in those treated with levothyroxine. Concomitant administration of levothyroxine and sympathomimetic agents to patients with coronary artery disease may precipitate coronary insufficiency.
Patients with nontoxic diffuse goiter or nodular thyroid disease- Exercise caution when administering levothyroxine to patients with nontoxic diffuse goiter or nodular thyroid disease in order to prevent precipitation of thyrotoxicosis (seeWARNINGS). If the serum TSH is already suppressed, levothyroxine sodium should not be administered (seeCONTRAINDICATIONS).
Associated endocrine disorders
Hypothalamic/pituitary hormone deficiencies- In patients with secondary or tertiary hypothyroidism, additional hypothalamic/pituitary hormone deficiencies should be considered, and, if diagnosed, treated (seePRECAUTIONS, Autoimmune polyglandular syndromefor adrenal insufficiency).
Autoimmune polyglandular syndrome
Occasionally, chronic autoimmune thyroiditis may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulin-dependent diabetes mellitus. Patients with concomitant adrenal insufficiency should be treated with replacement glucocorticoids prior to initiation of treatment with levothyroxine sodium. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated, due to increased metabolic clearance of glucocorticoids by thyroid hormone. Patients with diabetes mellitus may require upward adjustments of their antidiabetic therapeutic regimens when treated with levothyroxine (seePRECAUTIONS, Drug Interactions).
Other associated medical conditions
Infants with congenital hypothyroidism appear to be at increased risk for other congenital anomalies, with cardiovascular anomalies (pulmonary stenosis, atrial septal defect, and ventricular septal defect) being the most common association.
INFORMATION FOR PATIENTS
LABORATORY TESTS
PRECAUTIONS, Drug InteractionsDrug-Laboratory Test Interactions
WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION
PRECAUTIONS, Pediatric UseDOSAGE AND ADMINISTRATION
DRUG INTERACTIONS
Table 2: Drug-Thyroidal Axis InteractionsDrug or Drug Class EffectDrugs that may reduce TSH secretionhypothyroidism does not occurDrugs that alter thyroid hormone secretionDrugs that may decrease thyroid hormone secretion, which may result in hypothyroidismDrugs that may increase thyroid hormone secretion, which may result in hyperthyroidismDrugs that may decrease T4 absorption, which may result in hypothyroidismtherefore, the patient remains euthyroidDrugs that mayDrugs that may decrease serum TBG concentrationincrease serumTBG concentrationDrugs that may cause protein-binding site displacementDrugs that may alter T4 and T3 metabolismDrugs that may increase hepatic metabolism, which may result in hypothyroidismDrugs that may decrease T4 5'-deiodinase activity>aboveMiscellaneousTable 2
Table 2
Drug-Food Interactions
DRUG & OR LABORATORY TEST INTERACTIONS
Table 2CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis, Mutagenesis, and Impairment of FertilityPREGNANCY
PregnancyNURSING MOTHERS
Nursing MothersPEDIATRIC USE
DOSAGE AND ADMINISTRATIONTable 3PRECAUTIONS, Laboratory Tests
PRECAUTIONS
PRECAUTIONS, Laboratory TestsDOSAGE and ADMINISTRATION
GERIATRIC USE
WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATIONLEVOTHYROXINE SODIUM ADVERSE REACTIONS
PRECAUTIONSOVERDOSAGEOVERDOSAGE
OVERDOSAGEPRECAUTIONSADVERSE REACTIONS
DOSAGE & ADMINISTRATION
WARNINGSPRECAUTIONSPRECAUTIONS, Laboratory Tests
PRECAUTIONS, Drug InteractionsInformation for Patients
PRECAUTIONS
WARNINGSPRECAUTIONS, Laboratory Tests
PRECAUTIONS, Laboratory Tests
PRECAUTIONS, Pediatric Use
PRECAUTIONS , Drug-Food Interactions
Table 3
Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric HypothyroidismAGEDaily Dose Per Kg Body Weighta0-3 months10-15 mcg/kg/day3-6 months8-10 mcg/kg/day6-12 months6-8 mcg/kg/day1-5 years5-6 mcg/kg/day6-12 years4-5 mcg/kg/day>12 years but growth and puberty incomplete2-3 mcg/kg/dayGrowth and puberty complete1.7 mcg/kg/dayPRECAUTIONS, Laboratory TestsPediatric UsePregnancy
CONTRAINDICATIONSWARNINGSPRECAUTIONS
HOW SUPPLIED
STORAGE AND HANDLING
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:MAGNESIUM STEARATE
Microcrystalline Cellulose
Colloidal Silicone Dioxide
Sodium Starch Glycolate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Levothyroxine SodiumLevothyroxine Sodium TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
