These Highlights Do Not Include All The Information Needed To Use Tirosint® Safely And Effectively. See Full Prescribing Information For Tirosint.

These Highlights Do Not Include All The Information Needed To Use Tirosint® Safely And Effectively. See Full Prescribing Information For Tirosint.
SPL v12
SPL
SPL Set ID 7a7ade79-0165-4e31-b84e-667416c00c7e
Route
ORAL
Published
Effective Date 2022-09-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Glycerin Gelatin, Unspecified Water

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: oval Color: brown Size: 7 mm Score: 1
Marketing Status
NDA Active Since 2023-03-01 Until 2026-07-22
Description

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 [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ].

Dosage and Administration

Administer once daily, 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 an hour of certain foods that may affect TIROSINT absorption ( 2.1 ) Swallow TIROSINT capsules whole, do not cut, crush, or chew ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 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 )

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. ( 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 TIROSINT 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 )

Contraindications

TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ].

Adverse Reactions

Adverse reactions associated with TIROSINT therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10) ]. 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, arrhythmias, 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 Seizures have been reported rarely with the institution of levothyroxine therapy.

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 TIROSINT ( 7 )

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. TIROSINT capsules should be protected from heat, light and moisture. 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.

How Supplied

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid. They are supplied as follows: Table 7: TIROSINT Packaging Description - Boxes of 30 capsules, consisting of 3 blisters with 10 capsules each Strength (mcg) Color Shown on box and blister packing, not on individual capsules. Imprint Code NDC 13 Green A 71858-0005-4 25 Orange E 71858-0010-4 37.5 Dark Blue O 71858-0012-4 44 Red R 71858-0013-4 50 White G 71858-0015-4 62.5 Grey L 71858-0017-4 75 Purple H 71858-0020-4 88 Olive J 71858-0025-4 100 Yellow K 71858-0030-4 112 Rose M 71858-0035-4 125 Brown N 71858-0040-4 137 Turquoise P 71858-0045-4 150 Blue S 71858-0050-4 175 Lilac U 71858-0055-4 200 Pink Y 71858-0060-4 The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 10 capsules placed in individual cavities labeled with the dosage strength and the product name (TIROSINT).

Medication Information

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. ( 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 TIROSINT 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 )

Dosage and Administration

Administer once daily, 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 an hour of certain foods that may affect TIROSINT absorption ( 2.1 ) Swallow TIROSINT capsules whole, do not cut, crush, or chew ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 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 )

Contraindications

TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ].

Adverse Reactions

Adverse reactions associated with TIROSINT therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10) ]. 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, arrhythmias, 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 Seizures have been reported rarely with the institution of levothyroxine therapy.

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 TIROSINT ( 7 )

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. TIROSINT capsules should be protected from heat, light and moisture. 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.

How Supplied

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid. They are supplied as follows: Table 7: TIROSINT Packaging Description - Boxes of 30 capsules, consisting of 3 blisters with 10 capsules each Strength (mcg) Color Shown on box and blister packing, not on individual capsules. Imprint Code NDC 13 Green A 71858-0005-4 25 Orange E 71858-0010-4 37.5 Dark Blue O 71858-0012-4 44 Red R 71858-0013-4 50 White G 71858-0015-4 62.5 Grey L 71858-0017-4 75 Purple H 71858-0020-4 88 Olive J 71858-0025-4 100 Yellow K 71858-0030-4 112 Rose M 71858-0035-4 125 Brown N 71858-0040-4 137 Turquoise P 71858-0045-4 150 Blue S 71858-0050-4 175 Lilac U 71858-0055-4 200 Pink Y 71858-0060-4 The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 10 capsules placed in individual cavities labeled with the dosage strength and the product name (TIROSINT).

Description

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 [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ].

Section 42229-5

Hypothyroidism

TIROSINT is 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.

Section 42230-3
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: October 2022
PATIENT INFORMATION



TIROSINT® [tee-row-sent]



(levothyroxine sodium)



capsules, for oral use
What is the most important information I should know about TIROSINT?
  • Do not use TIROSINT to treat weight problems or weight loss.
  • Do not take more TIROSINT than your doctor prescribes for you to take. Over dosage or taking too much TIROSINT may cause life-threatening side effects or death.
What is TIROSINT?



TIROSINT is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland. TIROSINT is used to treat adults and children 6 years of age or older:
  • to replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone.
  • who need surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.
TIROSINT should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.



TIROSINT is unsuitable for children less than 6 years of age or who may be unable to swallow an intact capsule.
Do not take TIROSINT:
  • if your adrenal glands are not working well and you have not been treated for this problem.
Before you take TIROSINT, tell your doctor about all of your medical conditions, including if you:
  • have or had heart problems.
  • have or had thyroid nodules.
  • have kidney or pituitary gland problems.
  • have any food or drug allergies.
  • have a low red blood cell count (anemia).
  • have diabetes.
  • have weak bones (osteoporosis).
  • have or had a history of blood clotting problems.
  • have recently received radiation therapy with iodine (such as I-131).
  • are pregnant or plan to become pregnant. TIROSINT may harm your unborn baby. Your doctor may need to change your TIROSINT dose while you are pregnant.
  • are breastfeeding. TIROSINT can pass into your milk. Talk to your doctor about the best way to feed your baby if you take TIROSINT.
Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. TIROSINT may affect the way other medicines work, and other medicines may affect how TIROSINT works. You can ask your doctor or pharmacist for a list of medicines that interact with TIROSINT.
How should I take TIROSINT?
  • Take TIROSINT exactly as your doctor tells you to take it.
  • Your doctor will tell you how much TIROSINT to take each day.
  • Swallow TIROSINT capsules whole. Do not cut, crush, or chew TIROSINT capsules before swallowing. If you or your child cannot swallow TIROSINT capsules whole, tell your doctor. You may need a different medicine.
  • Your doctor may change your dose, if needed.
  • Take your dose of TIROSINT 1 time each day, 30 minutes to 1 hour before breakfast, on an empty stomach.
  • Certain medicines can interfere with how TIROSINT is absorbed by your body. Take TIROSINT:
    • at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate).
    • at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins.
  • Know the medicines that you take. Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
  • Certain foods including soybean flour, cotton seed meal, walnuts, and dietary fiber can affect your treatment and dose of TIROSINT. Talk to your doctor if you eat or drink these foods.
  • Do not remove TIROSINT capsules from the original blister package until you are ready to take them.
  • Your doctor should do certain blood tests while you are taking TIROSINT and may change your daily dose of TIROSINT as needed. You should not stop taking TIROSINT or change your dose unless your doctor tells you to.
  • It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well.
  • If you take too much TIROSINT or overdose, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What are the possible side effects of TIROSINT?



TIROSINT may cause serious side effects, including:
  • heart problems. You may experience an increased heart rate, chest pain and irregular heartbeat. Your risk of developing heart problems may be greater if you are elderly, have heart problems, or if you take too much TIROSINT. Your doctor may reduce your dose or stop treatment with TIROSINT for a while if you develop heart problems.
  • worsening diabetic control. If you are diabetic, it may be harder to control your blood sugar levels causing hyperglycemia while taking TIROSINT. Check your blood sugar levels closely after starting, changing, or stopping treatment with TIROSINT. Your doctor may have to change your diabetes treatment plan.
  • weak or brittle bones. Your risk of developing weak or brittle bones may be greater if you are post-menopausal or you take too much TIROSINT.
The most common side effects of TIROSINT include:
  • irregular heartbeat
  • chest pain
  • shortness of breath
  • leg cramps
  • headache
  • nervousness
  • hives or skin rash
  • irritability
  • sleep problems (insomnia)
  • tremors
  • muscle weakness
  • change in appetite
  • weight loss
  • vomiting
  • diarrhea
  • sweating a lot
  • heat intolerance
  • fever
  • changes in menstrual period
Other side effects may include:
  • partial hair loss during the first months of treatment with TIROSINT. This usually lasts a short period of time (temporary).
These are not all the possible side effects of TIROSINT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.



You may also report side effects to IBSA Pharma Inc. at 1-800-587-3513 or www.fda.gov/medwatch.
How should I store TIROSINT?
  • Store TIROSINT at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store TIROSINT away from heat, light, and moisture.
  • Keep TIROSINT in the original blister pack until you are ready to use it.
Keep TIROSINT and all medicines out of the reach of children.
General information about the safe and effective use of TIROSINT



Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TIROSINT for a condition for which it was not prescribed. Do not give TIROSINT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about TIROSINT that is written for health professionals.
What are the ingredients in TIROSINT?



Active ingredient : levothyroxine sodium



Inactive ingredients: gelatin, glycerin, and water



Manufactured by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland;



Marketed and distributed by: IBSA Pharma Inc., Parsippany, NJ 07054 USA



For more information, go to www.tirosint.com or call 1-800-587-3513.
7.6 Ketamine

Concurrent use of ketamine and TIROSINT may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.

10 Overdosage

The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5) and Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.

Reduce the TIROSINT dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

11 Description

TIROSINT (levothyroxine sodium) capsules for oral use contain synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules containing a viscous amber-colored liquid.

The inactive ingredients in TIROSINT are gelatin, glycerin and water.

16.1 How Supplied

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid. They are supplied as follows:

Table 7: TIROSINT Packaging Description - Boxes of 30 capsules, consisting of 3 blisters with 10 capsules each
Strength (mcg) Color
Shown on box and blister packing, not on individual capsules.
 Imprint Code NDC
13 Green A 71858-0005-4
25 Orange E 71858-0010-4
37.5 Dark Blue O 71858-0012-4
44 Red R 71858-0013-4
50 White G 71858-0015-4
62.5 Grey L 71858-0017-4
75 Purple H 71858-0020-4
88 Olive J 71858-0025-4
100 Yellow K 71858-0030-4
112 Rose M 71858-0035-4
125 Brown N 71858-0040-4
137 Turquoise P 71858-0045-4
150 Blue S 71858-0050-4
175 Lilac U 71858-0055-4
200 Pink Y 71858-0060-4

The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 10 capsules placed in individual cavities labeled with the dosage strength and the product name (TIROSINT).

5.2 Myxedema Coma

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.

8.4 Pediatric Use

TIROSINT is indicated for use in pediatric patients 6 years and older. The initial dose of TIROSINT varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3, 2.4)]

In children in whom a diagnosis of permanent hypothyroidism has not been established, discontinue TIROSINT administration for a trial period. Obtain serum T4 and TSH levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted.

8.5 Geriatric Use

Because of the increased prevalence of cardiovascular disease among the elderly, initiate TIROSINT therapy at less than the full replacement dose [ see Warnings and Precautions (5.1) and Dosage and Administration (2.3) ]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly .

4 Contraindications

TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

6 Adverse Reactions

Adverse reactions associated with TIROSINT therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10)]. 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, arrhythmias, 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

Seizures have been reported rarely with the institution of levothyroxine therapy.

7 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 TIROSINT ( 7)

7.7 Sympathomimetics

Concurrent use of sympathomimetics and TIROSINT may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.

12.2 Pharmacodynamics

Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.

1 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 ( 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 ( 1)
  • Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1)
7.3 Oral Anticoagulants

TIROSINT increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the TIROSINT dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.

12.1 Mechanism of Action

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

7.2 Antidiabetic Therapy

Addition of TIROSINT therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Careful monitor glycemic control, especially when thyroid therapy is started, changed, or discontinued [see Warnings and Precautions (5.5)] .

7.4 Digitalis Glycosides

TIROSINT may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may decrease when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.

16.2 Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. TIROSINT capsules should be protected from heat, light and moisture.

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.

5 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. ( 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 TIROSINT 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)
7.5 Antidepressant Therapy

Concurrent use of tricyclic (e.g., Amitriptyline) or tetracyclic (e.g., Maprotiline) antidepressants and TIROSINT may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. TIROSINT may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on TIROSINT may result in increased TIROSINT requirements.

7.9 Drug Food Interactions

Consumption of certain foods may affect TIROSINT absorption thereby necessitating adjustments in dosing [see Dosage and Administration (2.1)] . Soybean flour (infant formula), cottonseed meal, walnuts, and dietary fiber may bind and decrease the absorption of TIROSINT from the GI tract. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability.

2 Dosage and Administration
  • Administer once daily, 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 an hour of certain foods that may affect TIROSINT absorption ( 2.1)
  • Swallow TIROSINT capsules whole, do not cut, crush, or chew ( 2.1)
  • Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 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)
3 Dosage Forms and Strengths

TIROSINT capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid and are available as follows:

Strength (mcg) Imprint Code
13 A
25 E
37.5 O
44 R
50 G
62.5 L
75 H
88 J
100 K
112 M
125 N
137 P
150 S
175 U
200 Y

8 Use in Specific Populations

Pregnancy may require the use of higher doses of TIROSINT ( 2.3, 8.1)

7.8 Tyrosine Kinase Inhibitors

Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Closely monitor TSH levels in such patients.

2.2 General Principles of Dosing

The dose of TIROSINT for hypothyroidism or pituitary TSH suppression depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), and Drug Interactions (7)] . Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)].

The peak therapeutic effect of a given dose of TIROSINT may not be attained for 4 to 6 weeks.

17 Patient Counseling Information

Advise the patient and/or the caregiver to read the FDA-approved patient labeling (Patient Information Sheet).

5.5 Worsening of Diabetic Control

Addition of levothyroxine 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 [see Drug Interactions (7.2)] .

2.1 General Administration Information

Administer TIROSINT as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.

Administer TIROSINT at least 4 hours before or after drugs known to interfere with TIROSINT absorption [see Drug Interactions (7.1)]

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT absorption [see Drug Interactions (7.9) and Clinical Pharmacology (12.3)].

Swallow TIROSINT capsules whole, do not cut, crush, or chew.

7.10 Drug Laboratory Test Interactions

Consider changes in TBG concentration when interpreting T4 and T3 values. Measure and evaluate unbound (free) hormone and/or determine the free T4 index (FT4I) in this circumstance. Pregnancy, infectious hepatitis, estrogens, estrogen-containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, androgens and corticosteroids decrease TBG concentration. Familial hyper- or hypo-thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.

2.4 Monitoring Tsh And/or Thyroxine (t4) Levels

Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of TIROSINT may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.

Warning: Not for 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 [see Adverse Reactions (6), Drug Interactions (7.7), and Overdosage (10)].
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine sodium.

7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics

Many drugs can exert effects thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT (see Tables 2 to 5 below).

Table 2: Drugs That May Decrease T4 Absorption (Hypothyroidism)
Potential impact: Concurrent use may reduce the efficacy of TIROSINT by binding and delaying or preventing absorption, potentially resulting in hypothyroidism
Drug or Drug Class Effect
Calcium Carbonate

Ferrous Sulfate 		Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric-thyroxine complex. Administer TIROSINT at least 4 hours apart from these agents.
Orlistat Monitor patients treated concomitantly with orlistat and TIROSINT for changes in thyroid function.
Bile Acid Sequestrants

-Colesevelam

-Cholestyramine

-Colestipol

Ion Exchange Resins

-Kayexalate

-Sevelamer 		Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer TIROSINT at least 4 hours prior to these drugs or monitor thyrotropin (TSH) levels.
Other drugs:

Proton Pump Inhibitors

Sucralfate

Antacids

- Aluminum & Magnesium Hydroxides

- Simethicone 		Gastric acidity is an essential requirement for adequate absorption of levothyroxine. Sucralfate, antacids and proton pump inhibitors may cause hypochlorhydria, affect intragastric pH, and reduce levothyroxine absorption. Monitor patients appropriately
Table 3: Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxine (FT4) Concentration (Euthyroidism)
Drug or Drug Class Effect
Clofibrate

Estrogen-containing oral contraceptives

Estrogens (oral)

Heroin / Methadone

5-Fluorouracil

Mitotane

Tamoxifen 		These drugs may increase serum thyroxine-binding globulin (TBG) concentration.
Androgens / Anabolic Steroids

Asparaginase

Glucocorticoids

Slow-Release Nicotinic Acid 		These drugs may decrease serum TBG concentration.
Potential impact (below) : Administration of these agents with TIROSINT results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations.
Salicylates (> 2 g/day) Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total T4 levels may decrease by as much as 30%.
Other drugs:

Carbamazepine

Furosemide (> 80 mg IV)

Heparin

Hydantoins

Non-Steroidal Anti-inflammatory Drugs

- Fenamates 		These drugs may cause protein-binding site displacement . Furosemide has been shown to inhibit the protein binding of T4 to TBG and albumin, causing an increased free-T4 fraction in serum. Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total and free-T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid. Closely monitor thyroid hormone parameters.
Table 4: Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism)
Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased TIROSINT requirements.
Drug or Drug Class Effect
Phenobarbital

Rifampin 		Phenobarbital has been shown to reduce the response to thyroxine. Phenobarbital increases L-thyroxine metabolism by inducing uridine 5'-diphospho-glucuronosyltransferase (UGT) and leads to a lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism. Rifampin has been shown to accelerate the metabolism of levothyroxine.
Table 5: Drugs That May Decrease Conversion of T4 to T3
Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased.
Drug or Drug Class Effect
Beta-adrenergic antagonists

(e.g., Propranolol > 160 mg/day) 		In patients treated with large doses of propranolol (> 160 mg/day), T3 and T4 levels change, TSH levels remain normal, and patients are clinically euthyroid. Actions of particular beta-adrenergic antagonists may be impaired when the hypothyroid patient is converted to the euthyroid state.
Glucocorticoids

(e.g., Dexamethasone ≥ 4 mg/day) 		Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production (see Table 3 above).
Other:

Amiodarone 		Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, and decrease or normal free-T3) in clinically euthyroid patients.
Principal Display Panel 13 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0005-4

13 mcg



per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 25 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0010-4

25 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 44 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0013-4

44 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 50 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0015-4

50 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 75 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0020-4

75 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 88 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0025-4

88 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 100 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0030-4

100 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 112 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0035-4

112 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 125 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0040-4

125 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 137 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0045-4

137 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 150 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0050-4

150 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 175 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0055-4

175 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 200 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0060-4

200 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 37.5 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0012-4

37.5 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 62.5 Mcg Capsule Blister Pack Carton

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0017-4

62.5 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

5.3 Acute Adrenal Crisis in Patients With Concomitant Adrenal Insufficiency

Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy precipitate an acute adrenal crisis in patient with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with TIROSINT [see Contraindications (4)].

5.4 Prevention of Hyperthyroidism Or Incomplete Treatment of Hypothyroidism

TIROSINT has a narrow therapeutic index. Over- or under-treatment with TIROSINT may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of TIROSINT carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)] . Monitor for the presence of drug or food interactions when using TIROSINT and adjust the dose as necessary [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

5.6 Decreased Bone Mineral Density Associated With Thyroid Hormone Over Replacement

Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of TIROSINT that achieves the desired clinical and biochemical response to mitigate against this risk.

5.1 Cardiac Adverse Reactions in the Elderly and in Patients With Underlying Cardiovascular Disease

Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate TIROSINT therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3) and Use in Specific Populations (8.5)].

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive TIROSINT therapy. Monitor patients receiving concomitant TIROSINT and sympathomimetic agents for signs and symptoms of coronary insufficiency . If cardiac symptoms develop or worsen, reduce the TIROSINT dose or withhold it for one week and restart at a lower dose.

Structured Label Content

Section 42229-5 (42229-5)

Hypothyroidism

TIROSINT is 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.

Section 42230-3 (42230-3)
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: October 2022
PATIENT INFORMATION



TIROSINT® [tee-row-sent]



(levothyroxine sodium)



capsules, for oral use
What is the most important information I should know about TIROSINT?
  • Do not use TIROSINT to treat weight problems or weight loss.
  • Do not take more TIROSINT than your doctor prescribes for you to take. Over dosage or taking too much TIROSINT may cause life-threatening side effects or death.
What is TIROSINT?



TIROSINT is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland. TIROSINT is used to treat adults and children 6 years of age or older:
  • to replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone.
  • who need surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.
TIROSINT should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.



TIROSINT is unsuitable for children less than 6 years of age or who may be unable to swallow an intact capsule.
Do not take TIROSINT:
  • if your adrenal glands are not working well and you have not been treated for this problem.
Before you take TIROSINT, tell your doctor about all of your medical conditions, including if you:
  • have or had heart problems.
  • have or had thyroid nodules.
  • have kidney or pituitary gland problems.
  • have any food or drug allergies.
  • have a low red blood cell count (anemia).
  • have diabetes.
  • have weak bones (osteoporosis).
  • have or had a history of blood clotting problems.
  • have recently received radiation therapy with iodine (such as I-131).
  • are pregnant or plan to become pregnant. TIROSINT may harm your unborn baby. Your doctor may need to change your TIROSINT dose while you are pregnant.
  • are breastfeeding. TIROSINT can pass into your milk. Talk to your doctor about the best way to feed your baby if you take TIROSINT.
Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. TIROSINT may affect the way other medicines work, and other medicines may affect how TIROSINT works. You can ask your doctor or pharmacist for a list of medicines that interact with TIROSINT.
How should I take TIROSINT?
  • Take TIROSINT exactly as your doctor tells you to take it.
  • Your doctor will tell you how much TIROSINT to take each day.
  • Swallow TIROSINT capsules whole. Do not cut, crush, or chew TIROSINT capsules before swallowing. If you or your child cannot swallow TIROSINT capsules whole, tell your doctor. You may need a different medicine.
  • Your doctor may change your dose, if needed.
  • Take your dose of TIROSINT 1 time each day, 30 minutes to 1 hour before breakfast, on an empty stomach.
  • Certain medicines can interfere with how TIROSINT is absorbed by your body. Take TIROSINT:
    • at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate).
    • at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins.
  • Know the medicines that you take. Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
  • Certain foods including soybean flour, cotton seed meal, walnuts, and dietary fiber can affect your treatment and dose of TIROSINT. Talk to your doctor if you eat or drink these foods.
  • Do not remove TIROSINT capsules from the original blister package until you are ready to take them.
  • Your doctor should do certain blood tests while you are taking TIROSINT and may change your daily dose of TIROSINT as needed. You should not stop taking TIROSINT or change your dose unless your doctor tells you to.
  • It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well.
  • If you take too much TIROSINT or overdose, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What are the possible side effects of TIROSINT?



TIROSINT may cause serious side effects, including:
  • heart problems. You may experience an increased heart rate, chest pain and irregular heartbeat. Your risk of developing heart problems may be greater if you are elderly, have heart problems, or if you take too much TIROSINT. Your doctor may reduce your dose or stop treatment with TIROSINT for a while if you develop heart problems.
  • worsening diabetic control. If you are diabetic, it may be harder to control your blood sugar levels causing hyperglycemia while taking TIROSINT. Check your blood sugar levels closely after starting, changing, or stopping treatment with TIROSINT. Your doctor may have to change your diabetes treatment plan.
  • weak or brittle bones. Your risk of developing weak or brittle bones may be greater if you are post-menopausal or you take too much TIROSINT.
The most common side effects of TIROSINT include:
  • irregular heartbeat
  • chest pain
  • shortness of breath
  • leg cramps
  • headache
  • nervousness
  • hives or skin rash
  • irritability
  • sleep problems (insomnia)
  • tremors
  • muscle weakness
  • change in appetite
  • weight loss
  • vomiting
  • diarrhea
  • sweating a lot
  • heat intolerance
  • fever
  • changes in menstrual period
Other side effects may include:
  • partial hair loss during the first months of treatment with TIROSINT. This usually lasts a short period of time (temporary).
These are not all the possible side effects of TIROSINT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.



You may also report side effects to IBSA Pharma Inc. at 1-800-587-3513 or www.fda.gov/medwatch.
How should I store TIROSINT?
  • Store TIROSINT at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store TIROSINT away from heat, light, and moisture.
  • Keep TIROSINT in the original blister pack until you are ready to use it.
Keep TIROSINT and all medicines out of the reach of children.
General information about the safe and effective use of TIROSINT



Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TIROSINT for a condition for which it was not prescribed. Do not give TIROSINT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about TIROSINT that is written for health professionals.
What are the ingredients in TIROSINT?



Active ingredient : levothyroxine sodium



Inactive ingredients: gelatin, glycerin, and water



Manufactured by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland;



Marketed and distributed by: IBSA Pharma Inc., Parsippany, NJ 07054 USA



For more information, go to www.tirosint.com or call 1-800-587-3513.
7.6 Ketamine

Concurrent use of ketamine and TIROSINT may produce marked hypertension and tachycardia. Closely monitor blood pressure and heart rate in these patients.

10 Overdosage (10 OVERDOSAGE)

The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5) and Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.

Reduce the TIROSINT dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

11 Description (11 DESCRIPTION)

TIROSINT (levothyroxine sodium) capsules for oral use contain synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules containing a viscous amber-colored liquid.

The inactive ingredients in TIROSINT are gelatin, glycerin and water.

16.1 How Supplied

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid. They are supplied as follows:

Table 7: TIROSINT Packaging Description - Boxes of 30 capsules, consisting of 3 blisters with 10 capsules each
Strength (mcg) Color
Shown on box and blister packing, not on individual capsules.
 Imprint Code NDC
13 Green A 71858-0005-4
25 Orange E 71858-0010-4
37.5 Dark Blue O 71858-0012-4
44 Red R 71858-0013-4
50 White G 71858-0015-4
62.5 Grey L 71858-0017-4
75 Purple H 71858-0020-4
88 Olive J 71858-0025-4
100 Yellow K 71858-0030-4
112 Rose M 71858-0035-4
125 Brown N 71858-0040-4
137 Turquoise P 71858-0045-4
150 Blue S 71858-0050-4
175 Lilac U 71858-0055-4
200 Pink Y 71858-0060-4

The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 10 capsules placed in individual cavities labeled with the dosage strength and the product name (TIROSINT).

5.2 Myxedema Coma

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.

8.4 Pediatric Use

TIROSINT is indicated for use in pediatric patients 6 years and older. The initial dose of TIROSINT varies with age and body weight. Dosing adjustments are based on an assessment of the individual patient's clinical and laboratory parameters [see Dosage and Administration (2.3, 2.4)]

In children in whom a diagnosis of permanent hypothyroidism has not been established, discontinue TIROSINT administration for a trial period. Obtain serum T4 and TSH levels at the end of the trial period, and use laboratory test results and clinical assessments to guide diagnosis and treatment, if warranted.

8.5 Geriatric Use

Because of the increased prevalence of cardiovascular disease among the elderly, initiate TIROSINT therapy at less than the full replacement dose [ see Warnings and Precautions (5.1) and Dosage and Administration (2.3) ]. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly .

4 Contraindications (4 CONTRAINDICATIONS)

TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

6 Adverse Reactions (6 ADVERSE REACTIONS)

Adverse reactions associated with TIROSINT therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10)]. 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, arrhythmias, 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

Seizures have been reported rarely with the institution of levothyroxine therapy.

7 Drug Interactions (7 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 TIROSINT ( 7)

7.7 Sympathomimetics

Concurrent use of sympathomimetics and TIROSINT may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.

12.2 Pharmacodynamics

Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.

1 Indication and Usage (1 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 ( 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 ( 1)
  • Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1)
7.3 Oral Anticoagulants

TIROSINT increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the TIROSINT dose is increased. Closely monitor coagulation tests to permit appropriate and timely dosage adjustments.

12.1 Mechanism of Action

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

7.2 Antidiabetic Therapy

Addition of TIROSINT therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Careful monitor glycemic control, especially when thyroid therapy is started, changed, or discontinued [see Warnings and Precautions (5.5)] .

7.4 Digitalis Glycosides

TIROSINT may reduce the therapeutic effects of digitalis glycosides. Serum digitalis glycoside levels may decrease when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.

16.2 Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. TIROSINT capsules should be protected from heat, light and moisture.

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.

5 Warnings and Precautions (5 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. ( 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 TIROSINT 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)
7.5 Antidepressant Therapy

Concurrent use of tricyclic (e.g., Amitriptyline) or tetracyclic (e.g., Maprotiline) antidepressants and TIROSINT may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and central nervous system stimulation. TIROSINT may accelerate the onset of action of tricyclics. Administration of sertraline in patients stabilized on TIROSINT may result in increased TIROSINT requirements.

7.9 Drug Food Interactions (7.9 Drug-Food Interactions)

Consumption of certain foods may affect TIROSINT absorption thereby necessitating adjustments in dosing [see Dosage and Administration (2.1)] . Soybean flour (infant formula), cottonseed meal, walnuts, and dietary fiber may bind and decrease the absorption of TIROSINT from the GI tract. Grapefruit juice may delay the absorption of levothyroxine and reduce its bioavailability.

2 Dosage and Administration (2 DOSAGE AND ADMINISTRATION)
  • Administer once daily, 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 an hour of certain foods that may affect TIROSINT absorption ( 2.1)
  • Swallow TIROSINT capsules whole, do not cut, crush, or chew ( 2.1)
  • Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 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)
3 Dosage Forms and Strengths (3 DOSAGE FORMS AND STRENGTHS)

TIROSINT capsules are amber-colored, round/biconvex capsules, imprinted with a dosage strength specific letter on one side and containing a viscous amber-colored liquid and are available as follows:

Strength (mcg) Imprint Code
13 A
25 E
37.5 O
44 R
50 G
62.5 L
75 H
88 J
100 K
112 M
125 N
137 P
150 S
175 U
200 Y

8 Use in Specific Populations (8 USE IN SPECIFIC POPULATIONS)

Pregnancy may require the use of higher doses of TIROSINT ( 2.3, 8.1)

7.8 Tyrosine Kinase Inhibitors (7.8 Tyrosine-Kinase Inhibitors)

Concurrent use of tyrosine-kinase inhibitors such as imatinib may cause hypothyroidism. Closely monitor TSH levels in such patients.

2.2 General Principles of Dosing

The dose of TIROSINT for hypothyroidism or pituitary TSH suppression depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated [see Dosage and Administration (2.3), Warnings and Precautions (5), and Drug Interactions (7)] . Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)].

The peak therapeutic effect of a given dose of TIROSINT may not be attained for 4 to 6 weeks.

17 Patient Counseling Information (17 PATIENT COUNSELING INFORMATION)

Advise the patient and/or the caregiver to read the FDA-approved patient labeling (Patient Information Sheet).

5.5 Worsening of Diabetic Control

Addition of levothyroxine 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 [see Drug Interactions (7.2)] .

2.1 General Administration Information

Administer TIROSINT as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.

Administer TIROSINT at least 4 hours before or after drugs known to interfere with TIROSINT absorption [see Drug Interactions (7.1)]

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT absorption [see Drug Interactions (7.9) and Clinical Pharmacology (12.3)].

Swallow TIROSINT capsules whole, do not cut, crush, or chew.

7.10 Drug Laboratory Test Interactions (7.10 Drug-Laboratory Test Interactions)

Consider changes in TBG concentration when interpreting T4 and T3 values. Measure and evaluate unbound (free) hormone and/or determine the free T4 index (FT4I) in this circumstance. Pregnancy, infectious hepatitis, estrogens, estrogen-containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, androgens and corticosteroids decrease TBG concentration. Familial hyper- or hypo-thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.

2.4 Monitoring Tsh And/or Thyroxine (t4) Levels (2.4 Monitoring TSH and/or Thyroxine (T4) Levels)

Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of TIROSINT may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.

Warning: Not for Treatment of Obesity Or for Weight Loss (WARNING: NOT FOR 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 [see Adverse Reactions (6), Drug Interactions (7.7), and Overdosage (10)].
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine sodium.

7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics

Many drugs can exert effects thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT (see Tables 2 to 5 below).

Table 2: Drugs That May Decrease T4 Absorption (Hypothyroidism)
Potential impact: Concurrent use may reduce the efficacy of TIROSINT by binding and delaying or preventing absorption, potentially resulting in hypothyroidism
Drug or Drug Class Effect
Calcium Carbonate

Ferrous Sulfate 		Calcium carbonate may form an insoluble chelate with levothyroxine, and ferrous sulfate likely forms a ferric-thyroxine complex. Administer TIROSINT at least 4 hours apart from these agents.
Orlistat Monitor patients treated concomitantly with orlistat and TIROSINT for changes in thyroid function.
Bile Acid Sequestrants

-Colesevelam

-Cholestyramine

-Colestipol

Ion Exchange Resins

-Kayexalate

-Sevelamer 		Bile acid sequestrants and ion exchange resins are known to decrease levothyroxine absorption. Administer TIROSINT at least 4 hours prior to these drugs or monitor thyrotropin (TSH) levels.
Other drugs:

Proton Pump Inhibitors

Sucralfate

Antacids

- Aluminum & Magnesium Hydroxides

- Simethicone 		Gastric acidity is an essential requirement for adequate absorption of levothyroxine. Sucralfate, antacids and proton pump inhibitors may cause hypochlorhydria, affect intragastric pH, and reduce levothyroxine absorption. Monitor patients appropriately
Table 3: Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Affecting Free Thyroxine (FT4) Concentration (Euthyroidism)
Drug or Drug Class Effect
Clofibrate

Estrogen-containing oral contraceptives

Estrogens (oral)

Heroin / Methadone

5-Fluorouracil

Mitotane

Tamoxifen 		These drugs may increase serum thyroxine-binding globulin (TBG) concentration.
Androgens / Anabolic Steroids

Asparaginase

Glucocorticoids

Slow-Release Nicotinic Acid 		These drugs may decrease serum TBG concentration.
Potential impact (below) : Administration of these agents with TIROSINT results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations.
Salicylates (> 2 g/day) Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total T4 levels may decrease by as much as 30%.
Other drugs:

Carbamazepine

Furosemide (> 80 mg IV)

Heparin

Hydantoins

Non-Steroidal Anti-inflammatory Drugs

- Fenamates 		These drugs may cause protein-binding site displacement . Furosemide has been shown to inhibit the protein binding of T4 to TBG and albumin, causing an increased free-T4 fraction in serum. Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total and free-T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid. Closely monitor thyroid hormone parameters.
Table 4: Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism)
Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased TIROSINT requirements.
Drug or Drug Class Effect
Phenobarbital

Rifampin 		Phenobarbital has been shown to reduce the response to thyroxine. Phenobarbital increases L-thyroxine metabolism by inducing uridine 5'-diphospho-glucuronosyltransferase (UGT) and leads to a lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism. Rifampin has been shown to accelerate the metabolism of levothyroxine.
Table 5: Drugs That May Decrease Conversion of T4 to T3
Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased.
Drug or Drug Class Effect
Beta-adrenergic antagonists

(e.g., Propranolol > 160 mg/day) 		In patients treated with large doses of propranolol (> 160 mg/day), T3 and T4 levels change, TSH levels remain normal, and patients are clinically euthyroid. Actions of particular beta-adrenergic antagonists may be impaired when the hypothyroid patient is converted to the euthyroid state.
Glucocorticoids

(e.g., Dexamethasone ≥ 4 mg/day) 		Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production (see Table 3 above).
Other:

Amiodarone 		Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, and decrease or normal free-T3) in clinically euthyroid patients.
Principal Display Panel 13 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 13 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0005-4

13 mcg



per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 25 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 25 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0010-4

25 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 44 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 44 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0013-4

44 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 50 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 50 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0015-4

50 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 75 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 75 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0020-4

75 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 88 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 88 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0025-4

88 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 100 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 100 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0030-4

100 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 112 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 112 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0035-4

112 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 125 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 125 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0040-4

125 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 137 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 137 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0045-4

137 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 150 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 150 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0050-4

150 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 175 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 175 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0055-4

175 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 200 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 200 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0060-4

200 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 37.5 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 37.5 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0012-4

37.5 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

Principal Display Panel 62.5 Mcg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 62.5 mcg Capsule Blister Pack Carton)

TIROSINT ®



(levothyroxine sodium) capsules

NDC 71858-0017-4

62.5 mcg per capsule

Do not remove individual capsules from blister packaging until ready to use

Swallow capsule whole. Do not cut, crush, or chew.

R x Only



3 blisters x 10 capsules

IBSA

5.3 Acute Adrenal Crisis in Patients With Concomitant Adrenal Insufficiency (5.3 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency)

Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy precipitate an acute adrenal crisis in patient with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with TIROSINT [see Contraindications (4)].

5.4 Prevention of Hyperthyroidism Or Incomplete Treatment of Hypothyroidism (5.4 Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism)

TIROSINT has a narrow therapeutic index. Over- or under-treatment with TIROSINT may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and on glucose and lipid metabolism. Titrate the dose of TIROSINT carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)] . Monitor for the presence of drug or food interactions when using TIROSINT and adjust the dose as necessary [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

5.6 Decreased Bone Mineral Density Associated With Thyroid Hormone Over Replacement (5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement)

Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of TIROSINT that achieves the desired clinical and biochemical response to mitigate against this risk.

5.1 Cardiac Adverse Reactions in the Elderly and in Patients With Underlying Cardiovascular Disease (5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease)

Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate TIROSINT therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease [see Dosage and Administration (2.3) and Use in Specific Populations (8.5)].

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive TIROSINT therapy. Monitor patients receiving concomitant TIROSINT and sympathomimetic agents for signs and symptoms of coronary insufficiency . If cardiac symptoms develop or worsen, reduce the TIROSINT dose or withhold it for one week and restart at a lower dose.

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Source: dailymed · Ingested: 2026-02-15T11:48:42.046525 · Updated: 2026-03-14T22:30:36.203052