NP THYROID 30- levothyroxine, liothyronine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4), LIOTHYRONINE (UNII: 06LU7C9H1V) (LIOTHYRONINE - UNII:06LU7C9H1V)

Available from:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND 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 Iymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer. CONTRAINDICATIONS: Thyroid hormone preparations are generally co

Product summary:

HOW SUPPLIED: NP Thyroid tablets (thyroid tablets, USP) are supplied as follows: 30 mg (1/2 gr) are available in bottles of 30 (NDC 70934-333-30). NP Thyroid tablets are light tan, round tablets, debossed on one side with “AP” and a 3-digit code on the other side as follows: 30 mg (1/2 grain) - “329” MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev 0818-01

Authorization status:

unapproved drug other

Summary of Product characteristics

NP THYROID 30- LEVOTHYROXINE, LIOTHYRONINE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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NP THYROID 30
NP Thyroid (thyroid tablets, USP) for oral use is a natural
preparation derived from porcine thyroid
glands. They contain both tetraiodothyronine sodium (T4 levothyroxine)
and triiodothyronine sodium
(T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg
liothyronine (T3) per grain of
thyroid. The inactive ingredients are calcium stearate, dextrose
monohydrate, maltodextrin and mineral
o il.
CLINICAL PHARMACOLOGY: The steps in the synthesis of the thyroid
hormones are controlled by
thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the
anterior pituitary. This hormone’s
secretion is in turn controlled by a feedback mechanism effected by
the thyroid hormones themselves
and by thyrotropin releasing hormone (TRH), a tripeptide of
hypothalamic origin. Endogenous thyroid
hormone secretion is suppressed when exogenous thyroid hormones are
administered to euthyroid
individuals in excess of the normal gland’s secretion. The
mechanisms by which thyroid hormones
exert their
physiologic action are not well understood. These hormones enhance
oxygen consumption by most
tissues of the body, increase the basal metabolic rate, and the
metabolism of carbohydrates, lipids, and
proteins. Thus, they exert a profound influence on every organ system
in the body and are of particular
importance in the development of the central nervous system. The
normal thyroid gland contains
approximately 200 mcg of levothyroxine (T4) per gram of gland, and 15
mcg of liodothyronine (T3) per
gram. The ratio of these two hormones in the circulation does not
represent the ratio in the thyroid
gland, since about 80 percent of peripheral triiodothyronine comes
from monodeiodination of
levothyroxine. Peripheral monodeiodination of