Levothyroxine Sodium Capsules

Levothyroxine is a synthetic form of the thyroid hormone thyroxine (T4) that’s used to treat an underactive thyroid, known as hypothyroidism.

Order Now

What are Levothyroxine Sodium Capsules

Levothyroxine Sodium Capsules are a hormone medication used to treat hypothyroidism, or an under active thyroid. It works to replace or provide additional thyroid hormone, as the thyroid gland does not create enough on its own. This medication is taken orally, usually once a day, and helps to manage the symptoms of hypothyroidism such as fatigue, dry skin, constipation, depression, and weight gain. It is important to take this medication exactly as prescribed by your doctor, as too much may be harmful. Levothyroxine Sodium Capsules have been approved by the FDA and are considered safe and effective when used as directed. People with hypothyroidism should work closely with their healthcare provider to determine the right dosage and monitor their condition to ensure the best possible outcome.

What are the benefits of Levothyroxine Sodium Capsules?

Limited Ingredients
Levothyroxine Sodium Capsules contain only 4 simple ingredients: Levothyroxine, gelatin, glycerin and water.
Improved Tolerability
Levothyroxine Sodium Capsules may be better tolerated and have fewer absorption issues in patients with hypothyroidism.
Reduced Excipients (inactive ingredients) in Levothyroxine Sodium Capsules
Excipients are inactive ingredients that are added to tablet formulations during the manufacturing process. These substances often include but aren’t limited to starches, preservatives, and dyes. Levothyroxine Sodium Capsules are free of potentially problematic ingredients thereby improving the digestive process.
Twelve Dosage Strengths Available
Each Levothyroxine Sodium Capsules carton is color-coded for each dosage strength and each capsule is labeled with a letter code, to make it easier for you and your pharmacy to ensure that you get the same dosage of Levothyroxine Sodium Capsules that your doctor has prescribed. This allows your doctor to accurately determine the exact dosage that is right for you.

Prescribing Information,
Including Boxed Warning

Important Safety Information

Want more information?

We Can Help

13 mcg	25 mcg	50 mcg	75 mcg
88 mcg	100 mcg	112 mcg	125 mcg
137 mcg	150 mcg	175 mcg	200 mcg

General Information About Levothyroxine Sodium Capsules

Levothyroxine Sodium Capsules?

Levothyroxine sodium capsules are indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Using Levothyroxine Sodium Capsules

How Should I Use Levothyroxine Sodium Capsules?

Administer Levothyroxine sodium capsules as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.
Administer Levothyroxine sodium capsules at least 4-hours before or after drugs known to interfere with Levothyroxine sodium capsules absorption. Speak with your doctor to evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect levothyroxine sodium capsules absorption. Be sure to swallow Levothyroxine sodium capsules whole, do not cut or crush capsules.
Please see full prescribing information, including boxed warning, at www.yaralpharma.com

How Should I Store My Levothyroxine Sodium Capsules?

Levothyroxine sodium capsules should be stored at room temperature 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Levothyroxine sodium capsules should be protected from heat, light and moisture. Keep Levothyroxine sodium capsules out of the reach of children. Do not separate the individual cavities containing the drug from the intact blister as important information may be lost (i.e., manufacturer/distributor names, distributor contact phone number, lot number, and expiration date), and do not remove the individual capsules from blister packaging until ready to use.

What Are the Possible Adverse Reactions of Levothyroxine Sodium Capsules?

Adverse reactions associated with Levothyroxine sodium capsules are primarily those of hyperthyroidism due to therapeutic overdosage including 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.
Please see full prescribing information, including boxed warning, at www.yaralpharma.com

About Hypothyroidism

What is Hypothyroidism?

Hypothyroidism, or underactive thyroid, occurs when your thyroid gland is not producing enough thyroid hormone. The thyroid gland is a gland that’s located in your neck, just below the voice box or larynx. Thyroid hormone works to regulate your metabolism, or the way your body uses energy. Many patients live with the condition for years before they seek treatment because the symptoms of hypothyroidism can disguise themselves as simple day-to-day ailments.1
Ailments Include:
• Sluggishness and fatigue
• Weight gain
• Forgetfulness
• Feeling sad or depressed
• Dry skin, brittle hair
• Constipation
• Sore muscles
• Heavy or more frequent menstrual periods
Your healthcare provider can perform the necessary testing to confirm a diagnosis of hypothyroidism.
1. American Thyroid Association. Hypothyroidism: A Booklet for Patients and Their Families.
https://www.thyroid.org/wp-content/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf. Accessed March 27, 2019.

USE & IMPORTANT SAFETY INFORMATION for Levothyroxine Sodium Capsules

INDICATIONS AND USAGE
Levothyroxine sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with:

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

LIMITATIONS OF USE

LEVOTHYROXINE SODIUM CAPSULES are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in
iodine-sufficient patients.
LEVOTHYROXINE SODIUM CAPSULES are not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including TIROSINT, 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

LEVOTHYROXINE SODIUM CAPSULES are contraindicated in patients with 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.

ADVERSE REACTIONS
Adverse reactions with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage. They include the following:

General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
Musculoskeletal: tremors, muscle weakness, muscle spasm
Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
Respiratory: dyspnea
Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
Dermatologic: hair loss, flushing, rash
Endocrine: decreased bone mineral density
Reproductive: menstrual irregularities, impaired fertility

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.

DRUG INTERACTIONS
Many drugs and some foods can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT. Administer at least 4 hours before or after drugs that are known to interfere with absorption. See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism.

Please see Important Safety Information throughout and for Full Prescribing Information, including Boxed Warning, visit www.yaralpharma.com/levothyroxine-pi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

REF-1076-v3