INDICATIONS2

Hypothyroidism

EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Limitations of Use:

  • EUTHYROX is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with EUTHYROX may induce hyperthyroidism.

World's most dispensed levothyroxine brand with more than 53 million patients treated1

EUTHYROX® provides sealed levothyroxine tablets to safeguard your patients2,3

Ensure your patients receive levothyroxine with precise and protected potency2,3 at a generic price.4

AB-rated to Synthroid® (levothyroxine sodium)—bioequivalent.5

Prescribe blister packaged EUTHYROX.

Indicate dispense as written (DAW).

light and moisture icon

Light, oxygen, and moisture/humidity rob levothyroxine of potency3,6

  • Levothyroxine is highly sensitive to and must be protected from light and moisture/humidity.3,6
  • Exposure robs the treatment of its potency.3,6
  • Safeguarding levothyroxine potency can help maintain treatment consistency.6
target icon

Levothyroxine has a narrow therapeutic index (NTI)7

  • The medication requires a precise, consistent dosage to be effective and avoid side effects.7
  • Undertreated hypothyroid symptoms may include fatigue, thinning hair, constipation, muscle weakness, cramps and aches, weight gain, puffy face and bags under the eyes, depression, memory problems, and elevated cholesterol, among others.8,9
  • Undertreatment can result from tablets that have a reduced potency due to exposure.3,6
blister pack icon

EUTHYROX blister packages protect potency until the moment tablets are removed2,6

  • Sealed from exposure to light and moisture, EUTHYROX levothyroxine tablet potency is safeguarded.2,6
  • Bottled levothyroxine tablets are not safeguarded in the same way.3,6
  • Light, oxygen, and moisture/humidity have an impact on bottled levothyroxine while stored in the pharmacy, during prescription fulfillment, and while stored in the home.3,6
  • Bottled levothyroxine potency can decline below the USP specified potency range of 95% to 105% in just 30 days, while blister packaged levothyroxine retains its potency.3,10
money icon

EUTHYROX is a brand product at a generic price4

  • EUTHYROX coverage by health plans is generally aligned with generics or given preferred brand status.4
  • Patients typically have low out-of-pocket costs.4,11
blister pack

Blister packaging safeguards potency whereas bottles do not3

An independent 2-part study, “Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions,” was published in 2022.

EUTHYROX blister packaged tablets were evaluated and compared to bottled levothyroxine to determine the effectiveness of blister packaging in terms of safeguarding against loss of potency and changes to the physical properties of moisture gain, hardness, and disintegration time.

Figure: Levothyroxine Stability

STUDY RESULTS:3

Blister packages preserved physicochemical properties and potency better than bulk bottles. Bottled levothyroxine tablets showed a measurable decrease in both properties and potency with values below United States Pharmacopeia (USP) specifications at the end of the study.

Tablet integrity: Bottled tablets showed an increase in moisture content and in disintegration time, which factors in release and absorption rate of the drug.

Levothyroxine potency: Bottled levothyroxine showed a measurable decrease in potency over 105 days. At baseline, the average levothyroxine content was 101.4% of the stated strength. Values for 14 through 90 days ranged from 96.9% to 97.7%, and, at 105 days, the potency was 93.9%, which was outside of the USP specifications.

Bottled tablets in the 30-day full exposure experiment showed an observable decline in potency. Bottled tablets had 103.0% average levothyroxine potency at baseline; however, potency fell to 98.4% after 15 days and to 94.5% at 30 days.


Download the full published study that explains how EUTHYROX blister packaging is superior to bottles for protecting levothyroxine potency.3

Download the PDF


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Additional EUTHYROX benefits

Brand product at a generic price4

  • Many US health plans cover EUTHYROX as a generic or on a preferred tier.4
  • Most insured patients have low out-of-pocket costs for their EUTHYROX prescriptions.4,11

Worldwide leader in dispensed levothyroxine1

  • EUTHYROX is the world's most dispensed levothyroxine brand.
  • More than 53 million patients are treated annually using EUTHYROX to manage their hypothyroidism. Healthcare professionals worldwide dispense EUTHYROX more often than any other hypothyroidism treatment brand.

No dyes, lactose, or gluten2,12; braille-imprinted packaging

  • EUTHYROX tablets are dye-free, lactose-free, and gluten-free.2,12 This reduces the potential for adverse effects in patients with these associated sensitivities.
  • Outer box packaging includes braille encoding for visually impaired patients.
  • No history of EUTHYROX recalls in the United States.13
  • Tablets are scored with the dosage strength embossed.2

Blister packaging assures safeguarded levothyroxine tablet potency for patients with hypothyroidism.3

Prescribe EUTHYROX by name.

Always include "Dispense as Written (DAW)" to ensure patients receive levothyroxine with safeguarded potency.2,3

USA icon

Your state requires specific language to indicate a prescription be filled as written without substitutions.14

The following state-specific information is provided as guidance only. This table does not constitute legal advice, and Provell is not responsible for providing regular updates. Please consult your local authority regarding state-specific pharmacy regulations. Updated as of 2020.14

View State-specific Language to Use14

AlabamaSubstitution not allowed
AlaskaDo not substitute or Brand necessary
ArizonaSubstitution not allowed
ArkansasBrand necessary
CaliforniaDo not substitute or personally initialed Do not substitute box
ConnecticutDAW or Dispense as Written or Medically Necessary
DelawareBrand necessary or Brand medically necessary
District of ColumbiaBrand necessary or Substitution not allowed
FloridaBrand necessary or Substitution not allowed
GeorgiaBrand necessary or Brand Medically Necessary
GuamNo substitution or No sub
HawaiiBrand necessary or Brand medically necessary
IdahoDispense as written, Do not substitute, or any similar means
IllinoisMay not substitute box
IndianaSignature on appropriate line of 2-line prescription
IowaSubstitution not allowed without prescriber approval
KansasSignature on appropriate line of 2-line prescription or Substitution not allowed
KentuckyBrand necessary or Brand medically necessary or Do not substitute
LouisianaCheck box for no substitution
MaineBrand necessary or Check box for no substitution
MarylandBrand medically necessary or Substitution not allowed
MassachusettsNo substitution
MichiganDispense as written or DAW
MinnesotaDispense as written or DAW
MississippiSignature on appropriate line of 2-line prescription
MissouriDispense as written, Do not substitute, or any other means
MontanaBrand name medically necessary
NebraskaExpressly indicate Dispense as written or another means
NevadaDispense as written
New HampshireMedically necessary
New JerseySignature on appropriate line of 2-line prescription
New MexicoNo substitution or No sub
New YorkDispense as written in box or Brand medically necessary
North CarolinaSignature on appropriate line of 2-line prescription or expressly indicate in any manner
North DakotaBrand medically necessary
OhioDispense as written, DAW, or any other manner
OklahomaSubstitution is prohibited unless indicated by prescriber or patient
OregonDo not substitute
PennsylvaniaBrand necessary or Brand medically necessary
Puerto RicoDo not interchange
Rhode IslandBrand necessary or Brand medically necessary
South CarolinaSignature on appropriate line of 2-line prescription
South DakotaBrand necessary
TennesseeDispense as written, Brand name medically necessary, or other clear means
TexasBrand necessary or Brand medically necessary
UtahExpressly indicate or use preprinted checkbox
VermontBrand necessary, No substitution, Dispense as written, or DAW
VirginiaBrand medically necessary
WashingtonSignature on appropriate line of 2-line prescription
West VirginiaMedically necessary, Brand necessary, or Brand medically necessary
WisconsinExpressly indicate, eg, Brand medically necessary, No substitution, or Dispense as written
WyomingSubstitution not allowed

EUTHYROX Product Table

How Supplied2

Tablet Strength

Package Count

NDC (10‑digit)

GCN

Package Count

NDC (10‑digit)

GCN

EUTHYROX 25 mcg

30

72305‑025‑30

6648

90

72305‑025‑90

6648

EUTHYROX 50 mcg

30

72305‑050‑30

6649

90

72305‑050‑90

6649

EUTHYROX 75 mcg

30

72305‑075‑30

6650

90

72305‑075‑90

6650

EUTHYROX 88 mcg

30

72305‑088‑30

15523

90

72305‑088‑90

15523

EUTHYROX 100 mcg

30

72305‑100‑30

6651

90

72305‑0100‑90

6651

EUTHYROX 112 mcg

30

72305‑112‑30

6652

90

72305‑0112‑90

6652

EUTHYROX 125 mcg

30

72305‑125‑30

6653

90

72305‑0125‑90

6653

EUTHYROX 137 mcg

30

72305‑137‑30

20176

90

72305‑0137‑90

20176

EUTHYROX 150 mcg

30

72305‑150‑30

6654

90

72305‑0150‑90

6654

EUTHYROX 175 mcg

30

72305‑175‑30

6655

90

72305‑0175‑90

6655

EUTHYROX 200 mcg

30

72305‑200‑30

6656

90

72305‑0200‑90

6656

GCN, generic code number.

INDICATIONS2

Hypothyroidism

EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression

EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

  • EUTHYROX is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with EUTHYROX may induce hyperthyroidism.
  • EUTHYROX is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

IMPORTANT SAFETY INFORMATION2

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including EUTHYROX, 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

EUTHYROX is contraindicated in patients with uncorrected adrenal insufficiency.

WARNINGS AND PRECAUTIONS

  • EUTHYROX has a narrow therapeutic index. Overtreatment or undertreatment with EUTHYROX may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. Titrate the dose of EUTHYROX carefully and monitor response to titration to avoid these effects. Monitor for the presence of drug or food interactions when using EUTHYROX and adjust the dose as necessary.
  • In the elderly and in patients with cardiovascular disease, initiate EUTHYROX at lower doses than those recommended in younger individuals or in patients without cardiac disease.
  • Patients with coronary artery disease who are receiving EUTHYROX should be monitored closely during surgical procedures for cardiac arrythmias. Monitor patients during concomitant administration of EUTHYROX and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or worsen, reduce or withhold the EUTHYROX dose for one week and restart at a lower dose.
  • Use of oral thyroid hormone is not recommended to treat myxedema coma. Use products formulated for IV administration to treat myxedema coma.
  • Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with EUTHYROX. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated.
  • 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 EUTHYROX.
  • Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, administer the minimum dose of EUTHYROX that achieves the desired response.

ADVERSE REACTIONS

  • Adverse reactions associated with EUTHYROX therapy are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash.
  • In pediatric patients receiving levothyroxine therapy, pseudotumor cerebri and slipped capital femoral epiphysis have been reported. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in pediatric patients with resultant compromised adult height.
  • Seizures have been reported rarely with levothyroxine therapy.

DRUG INTERACTIONS

  • Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to EUTHYROX. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustment when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with EUTHYROX.

USE IN SPECIFIC POPULATIONS

  • EUTHYROX should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and EUTHYROX dose adjusted as needed.

PLEASE REFER TO THE FULL PRESCRIBING INFORMATION THAT CAN BE FOUND HERE.

This is the most important safety information you should know about EUTHYROX. For more information, talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. You can do this by contacting FDA at 1-800-FDA-1088 or you can visit www.fda.gov/medwatch.

To contact us regarding a product quality issue or submit a medical inquiry, click here.

Tell your healthcare provider if you experience any of the following: fast or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual period, hives or skin rash, or any other unusual medical event.

These are not all the possible side effects of EUTHYROX. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

EUTHYROX® is a registered trademark of Merck KGaA Darmstadt, Germany.

Synthroid® is a registered trademark of AbbVie, Inc.

USP: The US Pharmacopeia is a reference of uniform preparations for the most commonly used drugs—with tests to ensure their quality, potency and purity.

References: 1. Data on file. Merck KGaA, Darmstadt, Germany. 2. EUTHYROX package insert. Provell Pharmaceuticals LLC; 2022. 3. Chun J. Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions. AAPS Open. 2022;8:15. Accessed January 14, 2023. https://doi.org/10.1186/s41120-022-00062-5 4. Data on file. Managed Markets Insight & Technology LLC database; August 25, 2022. 5. FDA. Approved drug products with therapeutic equivalence evaluations. 43rd ed. 2023. Accessed February 27, 2023. https://www.fda.gov/media/71474/download 6. Benvenga S, Papi G, Antonelli A. Refractory hypothyroidism due to improper storage of levothyroxine tablets. Front Endocrinol (Lausanne). 2017;8:155. 7. FDA.gov. Real-world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug products. Accessed January 6, 2023. https://www.fda.gov/drugs/news-events-human-drugs/real-world-evidence-narrow-therapeutic-index-product-levothyroxine-reflects-therapeutic-equivalence 8. American Thyroid Association. Accessed March 14, 2023. https://www.thyroid.org/wp-content/uploads/publications/ctfp/ct_public_v162.pdf 9. British Thyroid Foundation. Accessed March 15, 2023. https://www.btf-thyroid.org/hypothyroidism-leaflet 10. United States Pharmacopeia. 2019. Accessed March 13, 2023. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/levothyroxine-na-tabs-rb-notice-20190927.pdf 11. Feldman R. The devil in the tiers. J Law Biosci. 2021;8(1):lsaa081. https://doi.org/10.1093/jlb/lsaa081 12. Data on file. Provell Pharmaceuticals LLC. 13. FDA.gov. Recalls, Market Withdrawals, & Safety Alerts. Accessed March 27, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts 14. National Association of Boards of Pharmacy. 2020 Survey of Pharmacy Law. Mount Prospect, IL; 2023.