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CYTOMEL®Index Section (liothyronine sodium)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

1 INDICATIONS AND USAGE

1.1 Hypothyroidism

1.2 Pituitary Thyroid-Stimulating Hormone(TSH) Suppression

1.3 Thyroid Suppression Test

2 DOSAGE AND ADMINISTRATION

2.1 General Principles of Dosing

2.2 Recommended Dosage for Hypothyroidism

2.3 Recommended Dosage for TSH Suppression in Well-Differentiated Thyroid Cancer

2.4 Recommended Dosage for Thyroid Suppression Test

2.5 Switching from Levothyroxine to CYTOMEL

2.6 Monitoring TSH and Triiodothyronine (T3) Levels

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease

5.2 Myxedema Coma

5.3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency

5.4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism

5.5 Worsening of Diabetic Control

5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics

7.2 Antidiabetic Therapy

7.3 Oral Anticoagulants

7.4 Digitalis Glycosides

7.5 Antidepressant Therapy

7.6 Ketamine

7.7 Sympathomimetics

7.8 Tyrosine-Kinase Inhibitors

7.9 Drug-Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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