amerithroid thyroid tablets, USP
amerithroid thyroid tablets, USP
made with care in the USA, by the makers of Unithroid®, the first FDA-approved levothyroxine tablet¹
Amerithroid is a Desiccated Thyroid Extract (DTE) prescription medication derived from porcine thyroid glands.²
it’s time to rethink treatment for hypothyroidism in some patients³
Synthetic treatments have been considered the standard of care for hypothyroidism for a long time. But not all patients respond to L-thyroxine (L-T4) monotherapy, making a strong case for the use of DTE in appropriate patients.³˒⁴
why DTE may be the right choice for some of your patients
L-T4 monotherapy may not be enough for some patients:⁵
![](data:image/svg+xml,<svg display="block" id="1410198439" role="presentation" viewBox="0 0 333 329" xmlns="http://www.w3.org/2000/svg"><g fill="transparent" height="236.01786053510875px" id="TY86WLVUZ" transform="translate(38.971 46.982)" width="256.0292756346907px"><path d="M 0.133 200.072 L 0.133 203.599 C 43.636 122.48 125.522 73.103 125.522 73.103 C 19.965 155.505 24.124 227.646 24.124 227.646 C 135.118 288.245 256.029 0 256.029 0 C -14.261 47.132 0.133 200.072 0.133 200.072" fill="rgb(51, 51, 153)" height="236.01786053510878px" id="QSNgwbaET" transform="translate(0 0)" width="256.0292756346907px"/></g></svg>)
Unmet needs—L-T4 monotherapy may not meet the needs of every patient with hypothyroidism⁵
Persistent symptoms—Up to 15% of patients on L-T4 monotherapy may continue to have symptoms, even if their blood tests show "normal" TSH levels⁶
Impaired systemic T3 production—Higher serum T4 levels in patients taking monotherapy may hinder systemic T3 production⁶
Impaired T4 to T3 conversion—Some patients may need higher levels of intracellular T3 than can be provided by L-T4 therapy alone⁷
key considerations
Like all DTE products, it predates the FDA’s enforcement process and is not FDA-approved. It remains available under the FDA’s enforcement discretion and is manufactured in a routinely FDA-inspected facility with U.S.-sourced active pharmaceutical ingredient (API) and full traceability.²˒⁸
Like all DTE products, it predates the FDA’s enforcement process and is not FDA-approved. It remains available under the FDA’s enforcement discretion and is manufactured in a routinely FDA-inspected facility with U.S.-sourced active pharmaceutical ingredient (API) and full traceability.²˒⁸
Like all DTE products, it predates the FDA’s enforcement process and is not FDA-approved. It remains available under the FDA’s enforcement discretion and is manufactured in a routinely FDA-inspected facility with U.S.-sourced active pharmaceutical ingredient (API) and full traceability.²˒⁸
A 2025 study in The Journal of Clinical Endocrinology & Metabolism found some patients continue to experience symptoms despite "normal" TSH levels, and that hypothyroidism remains associated with heightened risks of dementia and mortality.⁵
A 2025 study in The Journal of Clinical Endocrinology & Metabolism found some patients continue to experience symptoms despite "normal" TSH levels, and that hypothyroidism remains associated with heightened risks of dementia and mortality.⁵
A 2025 study in The Journal of Clinical Endocrinology & Metabolism found some patients continue to experience symptoms despite "normal" TSH levels, and that hypothyroidism remains associated with heightened risks of dementia and mortality.⁵
Patients who use compounding pharmacies typically receive a custom T4/T3 blend marketed as an alternative—not an actual DTE. These alternative products are unregulated.⁹
Patients who use compounding pharmacies typically receive a custom T4/T3 blend marketed as an alternative—not an actual DTE. These alternative products are unregulated.⁹
Patients who use compounding pharmacies typically receive a custom T4/T3 blend marketed as an alternative—not an actual DTE. These alternative products are unregulated.⁹
References
References: 1. U.S. Food and Drug Administration. Levothyroxine sodium products enforcement of August 14, 2001 compliance date and submission of new applications. Published July 2001. Accessed July 7, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august-14-2001-compliance-date-and-submission-new 2. Amerithroid Thyroid Tablets, USP [package insert]. Ridgewood, NJ: Oliva Therapeutics, LLC; 02/2025. 3. Heald AH, Premawardhana L, Taylor P, et al. Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. Int J Clin Pract. 2021;75(12):e14967. doi:10.1111/ijcp.14967 4. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 5. Beltrão FEL, Carvalhal G, Meneghini V, et al. Treatment of hypothyroidism that contains liothyronine is associated with reduced risk of dementia and mortality. J Clin Endocrinol Metab. 2025;111(2):561-571. doi:10.1210/clinem/dgaf367 6. McAninch EA, Bianco AC. The history and future of treatment of hypothyroidism. Ann Intern Med. 2016;164(1):50-56. doi:10.7326/M15-1799 7. Werneck de Castro JP, Fonseca TL, Ueta CB, et al. Differences in hypothalamic type 2 deiodinase ubiquitination explain localized sensitivity to thyroxine. J Clin Invest. 2015;125(2):769-781. doi:10.1172/JCI77588 8. AACE statement on the FDA’s actions to address unapproved thyroid medications. American Association of Clinical Endocrinology. Published September 4, 2025. Accessed July 7, 2026. https://pro.aace.com/recent-news-and-updates/aace-statement-fdas-actions-address-unapproved-thyroid-medications. 9. U.S. Food and Drug Administration. Notice to manufacturers, importers, and distributors of animal-derived thyroid products. Published August 6, 2025. Accessed July 7, 2026. https://www.fda.gov/media/188081/download.
References
References: 1. U.S. Food and Drug Administration. Levothyroxine sodium products enforcement of August 14, 2001 compliance date and submission of new applications. Published July 2001. Accessed July 7, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august-14-2001-compliance-date-and-submission-new 2. Amerithroid Thyroid Tablets, USP [package insert]. Ridgewood, NJ: Oliva Therapeutics, LLC; 02/2025. 3. Heald AH, Premawardhana L, Taylor P, et al. Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. Int J Clin Pract. 2021;75(12):e14967. doi:10.1111/ijcp.14967 4. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 5. Beltrão FEL, Carvalhal G, Meneghini V, et al. Treatment of hypothyroidism that contains liothyronine is associated with reduced risk of dementia and mortality. J Clin Endocrinol Metab. 2025;111(2):561-571. doi:10.1210/clinem/dgaf367 6. McAninch EA, Bianco AC. The history and future of treatment of hypothyroidism. Ann Intern Med. 2016;164(1):50-56. doi:10.7326/M15-1799 7. Werneck de Castro JP, Fonseca TL, Ueta CB, et al. Differences in hypothalamic type 2 deiodinase ubiquitination explain localized sensitivity to thyroxine. J Clin Invest. 2015;125(2):769-781. doi:10.1172/JCI77588 8. AACE statement on the FDA’s actions to address unapproved thyroid medications. American Association of Clinical Endocrinology. Published September 4, 2025. Accessed July 7, 2026. https://pro.aace.com/recent-news-and-updates/aace-statement-fdas-actions-address-unapproved-thyroid-medications. 9. U.S. Food and Drug Administration. Notice to manufacturers, importers, and distributors of animal-derived thyroid products. Published August 6, 2025. Accessed July 7, 2026. https://www.fda.gov/media/188081/download.
References
References: 1. U.S. Food and Drug Administration. Levothyroxine sodium products enforcement of August 14, 2001 compliance date and submission of new applications. Published July 2001. Accessed July 7, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/levothyroxine-sodium-products-enforcement-august-14-2001-compliance-date-and-submission-new 2. Amerithroid Thyroid Tablets, USP [package insert]. Ridgewood, NJ: Oliva Therapeutics, LLC; 02/2025. 3. Heald AH, Premawardhana L, Taylor P, et al. Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. Int J Clin Pract. 2021;75(12):e14967. doi:10.1111/ijcp.14967 4. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 5. Beltrão FEL, Carvalhal G, Meneghini V, et al. Treatment of hypothyroidism that contains liothyronine is associated with reduced risk of dementia and mortality. J Clin Endocrinol Metab. 2025;111(2):561-571. doi:10.1210/clinem/dgaf367 6. McAninch EA, Bianco AC. The history and future of treatment of hypothyroidism. Ann Intern Med. 2016;164(1):50-56. doi:10.7326/M15-1799 7. Werneck de Castro JP, Fonseca TL, Ueta CB, et al. Differences in hypothalamic type 2 deiodinase ubiquitination explain localized sensitivity to thyroxine. J Clin Invest. 2015;125(2):769-781. doi:10.1172/JCI77588 8. AACE statement on the FDA’s actions to address unapproved thyroid medications. American Association of Clinical Endocrinology. Published September 4, 2025. Accessed July 7, 2026. https://pro.aace.com/recent-news-and-updates/aace-statement-fdas-actions-address-unapproved-thyroid-medications. 9. U.S. Food and Drug Administration. Notice to manufacturers, importers, and distributors of animal-derived thyroid products. Published August 6, 2025. Accessed July 7, 2026. https://www.fda.gov/media/188081/download.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.
Amerithroid is a registered trademark of Oliva Therapeutics and is manufactured by Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therapeutics. All rights reserved. US-AME-26009-10/26
This site is intended for U.S. healthcare professionals only.
Amerithroid is a registered trademark of Oliva Therapeutics and is manufactured by Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therapeutics. All rights reserved. US-AME-26009-10/26
This site is intended for U.S. healthcare professionals only.
Amerithroid is a registered trademark of Oliva Therapeutics and is manufactured by Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therapeutics. All rights reserved. US-AME-26009-10/26
This site is intended for U.S. healthcare professionals only.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
IMPORTANT RISK INFORMATION (CONT’D)
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
IMPORTANT RISK INFORMATION (CONT’D)
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.
Note that DTE products, including amerithroid, have not been reviewed by the FDA for safety or efficacy.
Indications and Usage
Thyroid Tablets, USP are indicated for:
Replacement or supplemental therapy in hypothyroidism of any etiology (except transient hypothyroidism during recovery from subacute thyroiditis)
TSH suppression in the management of certain goiters and in thyroid cancer
IMPORTANT RISK INFORMATION (CONT’D)
contraindications
Uncorrected adrenal cortical insufficiency
Untreated thyrotoxicosis
Known hypersensitivity to thyroid hormone preparations or excipients
IMPORTANT RISK INFORMATION
BOXED WARNING
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, ALONE OR IN COMBINATION, SHOULD NOT BE USED FOR WEIGHT LOSS OR OBESITY TREATMENT.
IN EUTHYROID PATIENTS, DOSES WITHIN NORMAL HORMONAL REQUIREMENTS ARE INEFFECTIVE FOR WEIGHT REDUCTION.
LARGER DOSES MAY PRODUCE SERIOUS OR LIFE‑THREATENING TOXICITY, PARTICULARLY WHEN USED WITH SYMPATHOMIMETIC AMINES.
Warnings and Precautions
Cardiovascular Risk
Use with extreme caution in:
Patients with coronary artery disease or angina
Elderly patients
Therapy should be initiated at low doses and titrated carefully, as thyroid hormones may precipitate:
Angina
Arrhythmias
Myocardial infarction
Risk of Over‑Replacement (Hyperthyroidism)
Excess dosing may result in symptoms of hyperthyroidism, including:
Palpitations
Tachycardia
Nervousness
Heat intolerance
Liothyronine (T3) content may produce more rapid and pronounced effects
Endocrine Effects
May worsen:
Diabetes mellitus (increased insulin/oral hypoglycemic requirements)
Adrenal insufficiency (must be corrected prior to therapy)
Requires careful monitoring and dose adjustment
Anticoagulant Sensitivity
Thyroid hormones may increase response to oral anticoagulants
Monitor prothrombin time/INR and adjust anticoagulant dose as needed
Special Populations
Pediatric patients: Excess dosing may cause craniosynostosis
Pregnancy: Continue therapy; dose adjustments may be required
Lactation: Use with caution
Adverse Reactions
Adverse reactions are generally due to overdosage and resemble hyperthyroidism:
Palpitations
Tachycardia
Arrhythmias
Nervousness
Insomnia
Tremor
Heat intolerance
Other reactions are rare when properly dosed
Drug Interactions
Decreased absorption:
Cholestyramine (separate dosing by 4–5 hours)
Increased anticoagulant effects
Altered glycemic control with insulin or oral hypoglycemics
Estrogens/oral contraceptives:
May increase thyroid hormone requirements
Dosage and Administration
Dosage must be individualized based on clinical response and laboratory monitoring (TSH, T4, T3)
Typically initiated at low doses and titrated gradually, especially in patients with cardiovascular disease
Administer orally; consistency in administration is important
This is the most important safety information you should know about AMERITHROID®. For more information see full Prescribing Information, including BOXED WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
All patient and physician images are representative only.