Levothyroxine 50 mcg Tablets — Generic For Synthroid — Lupin

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.

Thyroid hormones, including levothyroxine sodium tablet, should not be used for the treatment of obesity or for weight loss.

Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity (6, 10).

Recent Major Changes

Dosage and Administration, Important Considerations for Dosing (2.2) 2/2024

Dosage and Administration, Monitoring TSH and/or Thyroxine (T4) Levels (2.4) 2/2024

Indications And Usage

Levothyroxine sodium tablet is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:

Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)

Limitations of Use

Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.

Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Dosage And Administration

Administer once daily, preferably on an empty stomach, one-half to one hour before breakfast. (2.1)

Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1)

Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. (2.1)

Advise patients to stop biotin and biotin-containing supplements at least 2 days before assessing TSH and/or T4 levels. (2.2)

Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications. Peak therapeutic effect may not be attained for 4 to 6 weeks. (2.2)

See full prescribing information for dosing in specific patient populations. (2.3)

Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. (2.4)

Dosage Forms And Strengths

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

Contraindications

Uncorrected adrenal insufficiency. (4)

Warnings And Precautions

• Serious risks related to overtreatment or undertreatment with levothyroxine sodium tablet: Titrate the dose of levothyroxine sodium tablet carefully and monitor response to titration. (5.1).
• Cardiac

• Serious risks related to overtreatment or undertreatment with levothyroxine sodium tablet: Titrate the dose of levothyroxine sodium tablet carefully and monitor response to titration. (5.1).
• Cardiac

Serious risks related to overtreatment or undertreatment with levothyroxine sodium tablet: Titrate the dose of levothyroxine sodium tablet carefully and monitor response to titration. (5.1).

Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease:Initiate levothyroxine sodium tablet at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. (2.3, 5.2, 8.5)

Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. (5.3)

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

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)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

Use In Specific Populations

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

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2025