NP THYROID 15
(+4 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NP Thyroid ® tablets (thyroid tablets, USP) are available as: 15 mg (1/4 gr) NDC 42192-327-30 in 30-count bottle NDC 42192-327-90 in 90-count bottle NDC 42192-327-01 in 100-count bottle 30 mg (1/2 gr) NDC 42192-329-30 in 30-count bottle NDC 42192-329-90 in 90-count bottle NDC 42192-329-01 in 100-count bottle NDC 42192-329-10 in 1000-count bottle 60 mg (1 gr) NDC 42192-330-30 in 30-count bottle NDC 42192-330-90 in 90-count bottle NDC 42192-330-01 in 100-count bottle NDC 42192-330-10 in 1000-count bottle 90 mg (1 1/2 gr) NDC 42192-331-30 in 30-count bottle NDC 42192-331-90 in 90-count bottle NDC 42192-331-01 in 100-count bottle NDC 42192-331-10 in 1000-count bottle 120 mg (2 gr) NDC 42192-328-30 in 30-count bottle NDC 42192-328-90 in 90-count bottle NDC 42192-328-01 in 100-count bottle NP Thyroid ® tablets are available in the following strengths: 15 mg (1/4 grain) - tan, oval-shaped tablet, debossed on one side with “AP” and “327” on the other side. 30 mg (1/2 grain) – tan, round tablet, debossed on one side with “AP” and “329” on the other side. 60 mg (1 grain) – tan, round tablet, debossed on one side with “AP” and “330” on the other side. 90 mg (1 1/2 grain) – tan, round tablet, debossed on one side with “AP” and “331” on the other side. 120 mg (2 grain) – tan, round tablet, debossed on one side with “AP” and “328” on the other side.; NDC 42192-327-01 NP Thyroid ® (Thyroid Tablets, USP) 1/4 grain (15 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................9.5 mcgliothyronine (T3)............................2.25 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day.NP Thyroid is a natural product with a strong, characteristic odor.Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:; NP thyroid 15; NDC 42192-329-01 NP Thyroid ® (Thyroid Tablets, USP) 1/2 grain (30 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................19 mcg liothyronine (T3)............................4.5 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:; NP thyroid 30; NDC 42192-330-01 NP Thyroid ® (Thyroid Tablets, USP) 1 grain (60 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................38 mcg liothyronine (T3)............................9 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:; NP thyroid 60; NDC 42192-331-01 NP Thyroid ® (Thyroid Tablets, USP) 1 and 1/2 grain (90 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................57 mcg liothyronine (T3)............................13.5 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:; NP thyroid 90; NDC 42192-328-01 NP Thyroid ® (Thyroid Tablets, USP) 2 grain (120 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................76 mcg liothyronine (T3)............................18 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:; NP thyroid 120
- HOW SUPPLIED NP Thyroid ® tablets (thyroid tablets, USP) are available as: 15 mg (1/4 gr) NDC 42192-327-30 in 30-count bottle NDC 42192-327-90 in 90-count bottle NDC 42192-327-01 in 100-count bottle 30 mg (1/2 gr) NDC 42192-329-30 in 30-count bottle NDC 42192-329-90 in 90-count bottle NDC 42192-329-01 in 100-count bottle NDC 42192-329-10 in 1000-count bottle 60 mg (1 gr) NDC 42192-330-30 in 30-count bottle NDC 42192-330-90 in 90-count bottle NDC 42192-330-01 in 100-count bottle NDC 42192-330-10 in 1000-count bottle 90 mg (1 1/2 gr) NDC 42192-331-30 in 30-count bottle NDC 42192-331-90 in 90-count bottle NDC 42192-331-01 in 100-count bottle NDC 42192-331-10 in 1000-count bottle 120 mg (2 gr) NDC 42192-328-30 in 30-count bottle NDC 42192-328-90 in 90-count bottle NDC 42192-328-01 in 100-count bottle NP Thyroid ® tablets are available in the following strengths: 15 mg (1/4 grain) - tan, oval-shaped tablet, debossed on one side with “AP” and “327” on the other side. 30 mg (1/2 grain) – tan, round tablet, debossed on one side with “AP” and “329” on the other side. 60 mg (1 grain) – tan, round tablet, debossed on one side with “AP” and “330” on the other side. 90 mg (1 1/2 grain) – tan, round tablet, debossed on one side with “AP” and “331” on the other side. 120 mg (2 grain) – tan, round tablet, debossed on one side with “AP” and “328” on the other side.
- NDC 42192-327-01 NP Thyroid ® (Thyroid Tablets, USP) 1/4 grain (15 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................9.5 mcgliothyronine (T3)............................2.25 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day.NP Thyroid is a natural product with a strong, characteristic odor.Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:
- NP thyroid 15
- NDC 42192-329-01 NP Thyroid ® (Thyroid Tablets, USP) 1/2 grain (30 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................19 mcg liothyronine (T3)............................4.5 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:
- NP thyroid 30
- NDC 42192-330-01 NP Thyroid ® (Thyroid Tablets, USP) 1 grain (60 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................38 mcg liothyronine (T3)............................9 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:
- NP thyroid 60
- NDC 42192-331-01 NP Thyroid ® (Thyroid Tablets, USP) 1 and 1/2 grain (90 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................57 mcg liothyronine (T3)............................13.5 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:
- NP thyroid 90
- NDC 42192-328-01 NP Thyroid ® (Thyroid Tablets, USP) 2 grain (120 mg) Rx Only 100 Tablets EACH TABLET CONTAINS: levothyroxine (T4)...........................76 mcg liothyronine (T3)............................18 mcg DIRECTIONS FOR USE: See Insert. USUAL DOSE: 15 mg - 180 mg once a day. NP Thyroid is a natural product with a strong, characteristic odor. Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F). MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Lot #/Exp. Date:
- NP thyroid 120
Overview
NP Thyroid ® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4 levothyroxine) and triiodothyronine sodium (T 3 liothyronine) providing 38 mcg levothyroxine (T 4 ) and 9 mcg liothyronine (T 3 ) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).
Indications & Usage
NP Thyroid ® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.
Dosage & Administration
The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings. Biotin supplementation may interfere with immunoassays for TSH, T 4 , and T 3 , resulting in erroneous thyroid hormone test results. Inquire whether patients are taking biotin or biotin-containing supplements. If so, advise them to stop biotin supplementation at least 2 days before assessing TSH and/or T 4 levels (see PRECAUTIONS). Thyroid hormones are given orally. In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition. Intramuscular administration is not advisable because of reported poor absorption. Hypothyroidism - Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg NP Thyroid®, with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with long standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require 60 to 120 mg/day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day usually result in normal serum levothyroxine (T 4 ) and triiodothyronine (T 3 ) levels. Adequate therapy usually results in normal TSH and T 4 levels after 2 to 3 weeks of therapy. Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T 4 , bound and free, and TSH. T 3 may be used in preference to levothyroxine (T 4 ) during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T 4 and T 3 is suspected. Myxedema Coma - Myxedema coma is usually precipitated in the hypothyroid patient of long-standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones. Corticosteroids should be administered routinely. T 4 and T 3 may be administered via a nasogastric tube but the preferred route of administration of both hormones is intravenous. Levothyroxine sodium (T 4 ) is given at starting dose of 400 mcg (100 mcg/mL) given rapidly, and is usually well tolerated, even in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given intravenously. Normal T 4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T 3 . Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication. Thyroid Cancer - Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine. TSH should be suppressed to low or undetectable levels. Therefore, larger amounts of thyroid hormone than those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy. Thyroid Suppression Therapy - Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Graves ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. A 50% or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy. For adults, the usual suppressive dose of levothyroxine (T 4 ) is 1.56 mcg/kg of body weight per day given for 7 to 10 days. These doses usually yield normal serum T 4 and T 3 levels and lack of response to TSH. Thyroid hormones should be administered cautiously to patients in whom there is strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source. Pediatric Dosage - Pediatric dosage should follow the recommendations summarized in Table 1. In infants with congenital hypothyroidism, therapy with full doses should be instituted as soon as the diagnosis has been made. Recommended Pediatric Dosage for Congenital Hypothyroidism NP Thyroid® Tablets Age Dose per day Daily dose per kg of body weight 0 - 6 mos. 15 - 30 mg 4.8 - 6 mg 6 - 12 mos. 30 - 45 mg 3.6 - 4.8 mg 1 - 5 yrs. 45 - 60 mg 3 - 3.6 mg 6 - 12 yrs. 60 - 90 mg 2.4 - 3 mg Over 12 yrs. Over 90 mg 1.2 - 1.8 mg
Warnings & Precautions
WARNINGS 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. The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.
Boxed Warning
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.
Contraindications
Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.
Adverse Reactions
Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).
Drug Interactions
Oral Anticoagulants — Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy. Insulin or Oral Hypoglycemics — Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements. The effects seen are poorly understood and depend upon a variety of factors such as dose and type of thyroid preparations and endocrine status of the patient. Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy. Cholestyramine or Colestipol - Cholestyramine or colestipol binds both T 4 and T 3 in the intestine, thus impairing absorption of these thyroid hormones. In vitro studies indicate that the binding is not easily removed. Therefore, four to five hours should elapse between administration of cholestyramine and thyroid hormones. Estrogen, Oral Contraceptives — Estrogens tend to increase serum thyroxine-binding globulin (TBg). In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements. However, if the patient’s thyroid gland has sufficient function, the decreased free levothyroxine will result in a compensatory increase in levothyroxine output by the thyroid. Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.
Storage & Handling
Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F).
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.