TIROSINT® Capsules Dosing
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TIROSINT® Capsules Dosing
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TIROSINT offers a wide range of options for precise LT4 dosing1
Available in 15 doses1
These dose strengths are for TIROSINT Capsules only.
Please refer to the Full Prescribing Information for complete instructions about dosing and administration.
Find a starting dose for your adult patients
Healthy, nonpregnant, nonelderly adults not at risk of disease
Dosing of TIROSINT must be individualized based on your patient’s age, weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific etiology of the condition being treated.1
You can use our interactive dosing calculator to find the right starting dose for your patients, but please refer to the Full Prescribing Information for details about dosing in specific populations.
Enter your patient’s weight or use the slider to find your patient’s weight
Based on the full replacement starting dose of 1.6 mcg/kg/day.
This dose calculator applies to both TIROSINT Capsules and TIROSINT-SOL.
Dosing guidelines for primary hypothyroidism in adults and in adolescents in whom growth and puberty are complete1
Adult patients with hypothyroidism
1.6 mcg per kg per day (full replacement dose)
- Use this dose in patients who are nonelderly, or have had hypothyroidism for only a brief time (such as a few months), or who are otherwise healthy
Increments of 12.5 to 25 mcg every 4 to 6 weeks until patient is clinically euthyroid and serum TSH levels return to normal
- Doses greater than 200 mcg per day are seldom required
- An inadequate response to daily doses greater than 300 mcg per day is rare; may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors
For elderly patients or patients with underlying cardiovascular disease
12.5 to 25 mcg per day (full replacement dose may be less than 1 mcg per kg per day in elderly patients)
Increments of 12.5 to 25 mcg every 6 to 8 weeks until patient is clinically euthyroid and serum TSH levels return to normal
- In elderly patients, the full replacement dose of TIROSINT may be less than 1 mcg per kg per day
In patients with severe long-standing hypothyroidism
12.5 to 25 mcg per day
Increments of 12.5 to 25 mcg every 2 to 4 weeks until patient is clinically euthyroid and serum TSH levels return to normal
In pregnant patients with pre-existing hypothyroidism
TIROSINT dose requirements may increase during pregnancy:
- Start monitoring serum TSH and free‐T4 as soon as pregnancy is confirmed and, at a minimum, during each trimester of pregnancy
- In patients with primary hypothyroidism, continue current TIROSINT regimen to maintain serum TSH in trimester-specific reference range
For patients with serum TSH above normal trimester-specific range:
- Increase TIROSINT dosage by 12.5 to 25 mcg per day
- Measure TSH every 4 weeks until a stable TIROSINT dose is reached and serum TSH levels are within normal trimester-specific range
Immediately after delivery:
- Reduce TIROSINT dosage to prepregnancy levels
- Measure serum TSH levels 4 to 8 weeks postpartum to ensure TIROSINT dose is appropriate
In pregnant patients with new-onset hypothyroidism
- In patients with moderate to severe signs and symptoms of hypothyroidism: 1.6 mcg per kg per day (full replacement dose)
- In patients with mild hypothyroidism (TSH <10 mIU/L): 1.0 mcg per kg per day
- Increase TIROSINT dosage by 12.5 to 25 mcg per day
- Measure TSH every 4 weeks until a stable TIROSINT dose is reached and serum TSH levels are within normal trimester-specific range
Ensuring your patient gets the right dose
Each dosage strength has a unique color code that appears on the front of the carton and a unique letter imprinted on each capsule.1
TIROSINT is supplied in cartons of 30 capsules. Capsules are contained in individual “wells” labeled with the dosage strength.1
TIROSINT is made in Switzerland in a facility dedicated to TIROSINT production only, so there is no risk of cross-contamination with other products.2
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Help patients get optimal results. Give your patients access to tips to help them get the most from treatment by establishing a routine.
INDICATION AND USAGE
TIROSINT is 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:
- TIROSINT is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
IMPORTANT SAFETY INFORMATION
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
- TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency.
Warnings and Precautions
- Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT 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 TIROSINT 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 click here for Full Prescribing Information, including BOXED WARNING, for TIROSINT.
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.
References: 1. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022. 2. Data on file, Institut Biochimique SA (IBSA).
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.