Levothyroxine 50 mcg Tablets — Generic For Synthroid — Lannett

These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS.

LEVOTHYROXINE SODIUM tablets, for oral use

Initial U.S. Approval: 2002

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

See full prescribing information for complete boxed warning

Indications And Usage

Levothyroxine sodium tablets is L-thyroxine (T4) indicated for:

Limitations of Use:

(1)

Dosage And Administration

(2)

Dosage Forms And Strengths

Tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg (3) (3)

Contraindications

(4)

Uncorrected adrenal insufficiency. (4)

(4)

Warnings And Precautions

• (5)
• Cardiac

• (5)
• Cardiac

(5)

Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate levothyroxine sodium tablets at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. (2.3, 5.1, 8.5)

Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. (5.2)

Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of levothyroxine sodium tablets treatment. (5.3)

Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. (5.4)

Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. (5.5)

Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density. Give the lowest effective dose. (5.6)

(5)

Adverse Reactions

Adverse reactions associated with levothyroxine sodium tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash. (6) (6)

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

Drug Interactions

See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to levothyroxine sodium tablets. (7) (7)

Use In Specific Populations

Pregnancy may require the use of higher doses of levothyroxine sodium tablets. (2.3, 8.1) (8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2020