Levothyroxine Sodium
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- LEVOTHYROXINE SODIUM DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- INDICATIONS & USAGE
- LEVOTHYROXINE SODIUM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- PEDIATRIC USE
- GERIATRIC USE
- LEVOTHYROXINE SODIUM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
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.
LEVOTHYROXINE SODIUM DESCRIPTION
Inactive Ingredients
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGEPRECAUTIONSDOSAGE AND ADMINISTRATION
PHARMACOKINETICS
AbsorptionPRECAUTIONS, Drug InteractionsDrug-Food InteractionsDistributionPRECAUTIONS, Drug InteractionsDrug-Laboratory Test InteractionsPRECAUTIONS, Pregnancy
MetabolismTable 1
Elimination
INDICATIONS & USAGE
Hypothyroidism
Pituitary TSH SuppressionWARNINGSPRECAUTIONSWARNINGSPRECAUTIONSWARNINGSPRECAUTIONS
LEVOTHYROXINE SODIUM CONTRAINDICATIONS
PRECAUTIONSDESCRIPTION, Inactive IngredientsWARNINGS
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.
CONTRAINDICATIONS
PRECAUTIONS
GeneralDrug Interactions
Effects on bone mineral density-
Patients with underlying cardiovascular disease-WARNINGSPRECAUTIONS, Geriatric UseDOSAGE AND ADMINISTRATION
Patients with nontoxic diffuse goiter or nodular thyroid disease-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
Table 2
Table 2
PEDIATRIC USE
DOSAGE AND ADMINISTRATIONTable 3PRECAUTIONS, Laboratory Tests
PRECAUTIONS
PRECAUTIONS, Laboratory TestsDOSAGE and ADMINISTRATION
GERIATRIC USE
WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATIONLEVOTHYROXINE SODIUM ADVERSE REACTIONS
PRECAUTIONSOVERDOSAGEGeneral:
Central nervous system:
Musculoskeletal:
Cardiovascular:
Respiratory:
Gastrointestinal:
Dermatologic:
Endocrine:
Reproductive:
OVERDOSAGE
PRECAUTIONSADVERSE REACTIONSTreatment of Overdosage
Acute Massive Overdosage
DOSAGE & ADMINISTRATION
General PrinciplesWARNINGSPRECAUTIONSPRECAUTIONS, 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
Levothyroxine SodiumLevothyroxine Sodium TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
