Levothyroxine Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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 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.


DESCRIPTION



DESCRIPTION


INACTIVE INGREDIENT




CLINICAL PHARMACOLOGY






INDICATIONS AND USAGEPRECAUTIONSDOSAGE AND ADMINISTRATION

PHARMACOKINETICS

PRECAUTIONS, Drug InteractionsDrug-Food Interactions
PRECAUTIONS, Drug InteractionsDrug-Laboratory Test InteractionsPRECAUTIONS, Pregnancy
Table 1




INDICATIONS & USAGE



WARNINGSPRECAUTIONSWARNINGSPRECAUTIONSWARNINGSPRECAUTIONS

CONTRAINDICATIONS

PRECAUTIONSDESCRIPTION, Inactive Ingredients

WARNINGS

Thyroid hormones, including Levothyroxine sodium tablets, USP, 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

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




Table 2
Table 2

Table 2






PEDIATRIC USE



DOSAGE AND ADMINISTRATIONTable 3PRECAUTIONS, Laboratory Tests


PRECAUTIONS
PRECAUTIONS, Laboratory TestsDOSAGE and ADMINISTRATION







GERIATRIC USE

WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

PRECAUTIONSOVERDOSAGE






OVERDOSAGE

PRECAUTIONSADVERSE REACTIONS

Treatment of Overdosage



DOSAGE & ADMINISTRATION

General Principles
WARNINGSPRECAUTIONSPRECAUTIONS, Laboratory Tests
PRECAUTIONS, Drug InteractionsInformation for Patients

PRECAUTIONS

Specific Patient Populations
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














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Levothyroxine Sodium

Levothyroxine Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-415(NDC:0781-5184)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM LEVOTHYROXINE 0.1 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
yellow 9 mm 100;GG;335 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-415-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021342 2011-07-22


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