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Important Risk Information - Consumer

Use and Important Risk Information
What is NP Thyroid® (thyroid tablets, USP) used for?
NP THYROID® 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.
When should I not take NP Thyroid®?

NP THYROID® should not be used for weight loss. Do not use NP THYROID® if you have hyperthyroidism, overactive thyroid, uncorrected adrenal problems, or are allergic to any of its ingredients.

What warnings should I know about NP Thyroid®?

Large doses of NP THYROID® may cause serious or life-threatening side effects, including chest pain, increased pulse rate, rapid, strong, irregular heartbeat, and excessive sweating.

NP THYROID® should be used with caution in people with heart disease, on diabetes medication, or on blood thinning medication.

Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this will usually go away on its own.

What should I tell my healthcare provider?

Tell your doctor immediately if you experience chest pain, increased pulse rate, rapid, strong, irregular heartbeat, excessive sweating, or any other unusual event.

Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking NP THYROID®.

If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor and immediately tell your doctor if there are any changes.

Tell your doctor if you are allergic to any foods or drugs, are pregnant or plan to become pregnant, are breastfeeding or are taking any other drugs, as well as prescription and over-the-counter products.

What are the side effects of NP Thyroid®?

Side effects may include chest pain, increased pulse rate, rapid, strong, irregular heartbeat, or excessive sweating. If you experience these side effects, immediately contact your doctor.

What other medications might interact with NP Thyroid®?

NP THYROID® can interact with some medications, such as oral anticoagulants, which are medicines used to thin the blood, insulin or oral medications used to treat diabetes, certain medications used to treat high cholesterol levels, and estrogen containing birth control pills.

Control number 02/2019

INDICATIONS & IMPORTANT RISK INFORMATION INCLUDING BLACK BOX WARNING
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.

Indication

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.