Note that DTE products, including NP Thyroid®, have not been reviewed by the FDA for safety or efficacy.
IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING & INDICATIONS
Important Risk Information
Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. 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.
- NP Thyroid® is contraindicated in patients with uncorrected adrenal
insufficiency, untreated thyrotoxicosis, and hypersensitivity to any component of the
product.
- In the elderly and in patients with cardiovascular disease, NP Thyroid®
should be used with greater caution than younger patients or those without
cardiovascular disease.
- Use of NP Thyroid® in patients with diabetes mellitus or adrenal cortical
insufficiency may worsen the intensity of their symptoms.
- The therapy of myxedema coma requires simultaneous administration of glucocorticoids.
- Concomitant use of NP Thyroid® with oral anticoagulants alters the
sensitivity of oral anticoagulants. Prothrombin time should be closely monitored in
thyroid-treated patients on oral anticoagulants.
- In infants, excessive doses of NP Thyroid® may produce craniosynostosis.
- Partial loss of hair may be experienced by children in the first few months of therapy
but is usually transient.
- Adverse reactions associated with NP Thyroid® therapy are primarily those of
hyperthyroidism due to therapeutic overdosage.
- Many drugs and some laboratory tests may alter the therapeutic response to NP
Thyroid®. 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 adjustments when regularly administering within one hour of certain foods that may
affect absorption.
- NP Thyroid® should not be discontinued during pregnancy, and hypothyroidism
diagnosed during pregnancy should be promptly treated.
Indications
NP Thyroid® (thyroid tablets, USP) is a prescription medicine that is used to
treat a condition called hypothyroidism from any cause, except for cases of temporary
hypothyroidism, which is usually associated with an inflammation of the thyroid
(thyroiditis). It is meant to replace or supplement a hormone that is usually made by your
thyroid gland.
NP Thyroid® is also used in the treatment and prevention of normal functioning
thyroid goiters, such as thyroid nodules, Hashimoto’s thyroiditis, multinodular goiter, and
in the management of thyroid cancer.
Revised 10/2023
You may report side effects to Acella Pharmaceuticals, LLC at 1-800-541-4802 or to the FDA at 1-800-FDA-1088.
Please click here for full Prescribing Information, including Boxed Warning.