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Levothyroxine Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity 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.

LEVOTHYROXINE SODIUM DESCRIPTION


Levothyroxine Sodium

Inactive Ingredients

Strength (mcg)Color Additive(s)

CLINICAL PHARMACOLOGY






INDICATIONS AND USAGEPRECAUTIONSDOSAGE AND ADMINISTRATION

PHARMACOKINETICS

AbsorptionPRECAUTIONS, Drug InteractionsDrug-Food Interactions

DistributionPRECAUTIONS, Drug InteractionsDrug-Laboratory Test InteractionsPRECAUTIONS, Pregnancy

MetabolismTABLE 1

Elimination- Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces. Approximately 20% of T4 is eliminated in the stool. Urinary excretion of T4 decreases with age.

Table 1: Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients
2 Includes TBG, TBPA, and TBAHormoneRatio in ThyroglobulinBiologic Potencyt1/2 (days)Protein Binding (%)2Levothyroxine (T4)10 - 2016-7199.96Liothyronine (T3)14299.5


INDICATIONS & USAGE



Hypothyroidism

Pituitary TSH Suppression -WARNINGSPRECAUTIONSWARNINGSPRECAUTIONSWARNINGSPRECAUTIONS

LEVOTHYROXINE SODIUM CONTRAINDICATIONS

PRECAUTIONSDESCRIPTION, Inactive Ingredients

WARNINGS

WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity 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

PRECAUTIONS

General
Drug Interactions

Effects on bone mineral density

Patients with underlying cardiovascular diseaseWARNINGSPRECAUTIONS, Geriatric UseDOSAGE 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

General

PRECAUTIONS, Drug InteractionsDrug-Laboratory Test Interactions

Adults
WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION

Pediatrics

PRECAUTIONS, Pediatric UseDOSAGE AND ADMINISTRATION

Secondary (pituitary) and tertiary (hypothalamic) hypothyroidism


DRUG INTERACTIONS

Table 2
Table 2


Table 2
Table 2

Drug-Food Interactions

Drug-Laboratory Test InteractionsTable 2

Carcinogenesis, Mutagenesis, and Impairment of Fertility


Pregnancy - Category A



Nursing Mothers

PEDIATRIC USE

General

DOSAGE AND ADMINISTRATIONTable 3PRECAUTIONS, Laboratory Tests


PRECAUTIONS
PRECAUTIONS, Laboratory TestsDOSAGE AND ADMINISTRATION




Acquired Hypothyroidism in Pediatric Patients



GERIATRIC USE

WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION

LEVOTHYROXINE SODIUM ADVERSE REACTIONS

PRECAUTIONSOVERDOSAGE
General:
Central nervous system:
Musculoskeletal:
Cardiovascular:
Respiratory:
Gastrointestinal:
Dermatologic:
Endocrine:
Reproductive:





OVERDOSAGE

PRECAUTIONSADVERSE REACTIONS

Treatment of Overdosage


Acute Massive Overdosage

DOSAGE & ADMINISTRATION


General Principles:
WARNINGSPRECAUTIONSPRECAUTIONS, Laboratory Tests
PRECAUTIONS, Drug Interactions

PRECAUTIONS

Specific Patient Populations:
WARNINGSPRECAUTIONS, Laboratory Tests




PRECAUTIONS, Laboratory Tests

General Principles

PRECAUTIONS, Pediatric Use
PRECAUTIONS, Drug-Food Interactions

Newborns


Infants and Children
Table 3



PRECAUTlONS, Laboratory TestsPediatric Use
PREGNANCY





CONTRAINDICATIONSWARNINGSPRECAUTIONS



STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium

Levothyroxine Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-639(NDC:0527-1638)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM LEVOTHYROXINE 0.137 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
LACTOSE
MAGNESIUM STEARATE
cellulose, microcrystalline
STARCH, CORN
ACACIA
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 1
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
blue 7 mm JSP;564 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-639-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021210 2011-12-08


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