When it comes to hypothyroidism, not all levothyroxine medications are created equal.
Effective July 1, 2024, YARAL Pharma’s Levothyroxine Sodium Capsules — the authorized generic of Tirosint® (levothyroxine sodium) capsules – will be the only generic levothyroxine gel capsule option available in the U.S. market. Formulated to improve the tolerability of LT4 therapy1, these capsules are:
Specially formulated to contain only 4 simple ingredients: levothyroxine, gelatin, glycerin, and water.1
Free from sugars, dyes, alcohol, wheat starch (gluten), lactose, or any other excipients (inactive ingredients) commonly used to make traditional levothyroxine tablets.1
Available in twelve dosage strengths.1
Each year, millions of patients are treated with Levothyroxine to manage hypothyroidism, and for those who have trouble tolerating traditional Levothyroxine tablets, the answer may lie in the dosage form.
Levothyroxine Sodium Capsules, a unique gel-cap formulation with only four ingredients, are designed to address concerns of absorption and tolerability. This is especially important for patients with hypothyroidism who have allergies or sensitivities to ingredients commonly found in Levothyroxine tablets or for those with certain gastrointestinal conditions.3
Excipients
YARAL Levothyroxine
LT4 Tablets*
Glycerin
Gelatin
Water
Lactose
Sucrose
Povidine Iodine
Talc
Acacia
Color Additives
*Ingredients may vary by product
As a pharmacist, your expertise and counsel are invaluable. If patients struggle with traditional levothyroxine tablets, consider recommending YARAL Pharma’s capsules as an alternative. For more information, Click Here
WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including Levothyroxine Sodium Capsules, 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.
INDICATIONS AND USAGE Hypothyroidism primary (thyroidal). Secondary Levothyroxine Sodium Capsules is indicated as a replacement therapy in adults and pediatric patients 6 years and older with (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium Capsules is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer.
CONTRAINDICATIONS
Uncorrected adrenal insufficiency
WARNINGS AND PRECAUTIONS
Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease. Initiate Levothyroxine Sodium Capsules, at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.
Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of Levothyroxine Sodium Capsules, treatment.
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.
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.
Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose.
Use for the suppression of nontoxic diffuse goiter or nodular thyroid disease: Use is not recommended in iodine-insufficient patients.
LIMITATIONS OF USE
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients,
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
ADVERSE REACTIONS Common adverse reactions with levothyroxine therapy are primarily those of hypothyroidism due to therapeutic overdosage. They include the following:
ADVERSE REACTIONS IN CHILDREN Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.
HYPERSENSITIVITY REACTIONS Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid hormone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.
For Full Prescribing Information, including Boxed Warning, visit
www.yaralpharma.com/levothyroxine-pi.
To report SUSPECTED ADVERSE REACTIONS, contact
YARAL Pharma Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
For the latest updates on YARAL Pharma Inc., visit www.yaralpharma.com or scan the QR code:
GBI Research, “Endocrinology Market to 2018”, March 2012.
McMillan M, Rotenberg KS, Vora K, et al. Comorbidities, concomitant medications, and diet as factors affecting levothyroxine therapy; results of the CONTROL Surveillance Project. Drugs in R&D. 2015;16(1):53-68.
Levothyroxine Sodium Capsules, a unique gel-cap formulation with only four ingredients, are designed to address concerns of absorption and tolerability. This is especially important for patients with hypothyroidism who have allergies or sensitivities to ingredients commonly found in Levothyroxine tablets or for those with certain gastrointestinal conditions.3
