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





aboveTable 2
Table 2

Drug-Food Interactions


Drug-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:49349-368(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 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-368-02 30 in 1 BLISTER PACK
2 NDC:49349-368-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076752 2011-05-23


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