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

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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 UseDOSAGE AND ADMINISTRATION
WARNINGSCONTRAINDICATIONS

Associated endocrine disorders
PRECAUTIONS, Autoimmune polyglandular syndrome

Autoimmune polyglandular syndrome
PRECAUTIONS, Drug Interactions

Other associated medical conditions


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 hypothyroidismand, therefore, 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 activityaboveMiscellaneousTable 2
Table 2

Drug-Food Interactions



DRUG & OR LABORATORY TEST INTERACTIONS

Drug-Laboratory Test Interactions
Table 2

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, and Impairment of Fertility


PREGNANCY

Pregnancy




NURSING MOTHERS

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



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



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:49349-240(NDC:0781-5181)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM LEVOTHYROXINE 0.050 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
white 9 mm 50;GG;332 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-240-02 30 in 1 BLISTER PACK
2 NDC:49349-240-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076752 2011-05-03


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