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Levothyroxine Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

LEVOTHYROXINE SODIUM DESCRIPTION



Levothyroxine Sodium

INACTIVE INGREDIENT































CLINICAL PHARMACOLOGY






INDICATIONS AND USAGE, PRECAUTIONSDOSAGE AND ADMINISTRATION

PHARMACOKINETICS

PRECAUTIONS, Drug InteractionsDrug-Food Interactions
PRECAUTIONS, 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 Ingredients

WARNINGS


CONTRAINDICATIONS

PRECAUTIONS

General
Drug 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





aboveTable 2
Table 2

Drug-Food Interactions


DRUG & OR LABORATORY TEST INTERACTIONS

Table 2

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY





NURSING MOTHERS



PEDIATRIC USE



DOSAGE AND ADMINISTRATIONTable 3PRECAUTIONS, Laboratory Tests


PRECAUTIONS
PRECAUTIONS, Laboratory TestsDOSAGE and ADMINISTRATION







GERIATRIC USE

WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION

LEVOTHYROXINE SODIUM ADVERSE REACTIONS

PRECAUTIONSOVERDOSAGE






OVERDOSAGE

PRECAUTIONSADVERSE 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



PRECAUTIONS, Laboratory TestsPediatric UsePregnancy



CONTRAINDICATIONSWARNINGSPRECAUTIONS


HOW SUPPLIED







































STORAGE AND HANDLING













PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Levothyroxine Sodium

Levothyroxine Sodium

















Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-334(NDC:0781-5182)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM LEVOTHYROXINE 0.075 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
purple 9 mm GG;75;333 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-334-02 30 in 1 BLISTER PACK
2 NDC:49349-334-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076752 2011-06-27


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