LEVOTHYROXINE AND LIOTHYRONINE THYROID- levothyroxine and liothyronine tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Westminster Pharmaceuticals, LLC

INN (International namn):

LEVOTHYROXINE

Sammansättning:

LEVOTHYROXINE 19 ug

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Levothyroxine and Liothyronine 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. 3. As diagnostic agents in suppression tests to differentiate suspe

Produktsammanfattning:

Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are supplied as follows: 15 mg (1/4 grain) are available in bottles of 100 (NDC 69367-159-04), 30 mg (1/2 grain) are available in bottles of 100 (NDC 69367-155-04), 60 mg (1 grain) are available in bottles of 100 (NDC 69367-156-04), and 90 mg (1 1/2 grain) are available in bottles of 100 (NDC 69367-157-04), and 120 mg (2 grain) are available in bottles of 100 (NDC 69367-158-04). Levothyroxine and Liothyronine tablets are light tan, round tablets, debossed on one side with "WP" and on the other side as follows: Store in a tight container protected from light and moisture. Store between 15°-30°C (59°-86°F). All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

Bemyndigande status:

unapproved drug other

Produktens egenskaper

LEVOTHYROXINE AND LIOTHYRONINE THYROID- LEVOTHYROXINE AND LIOTHYRONINE
TABLET
WESTMINSTER PHARMACEUTICALS, LLC
_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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LEVOTHYROXINE AND LIOTHYRONINE (THYROID TABLETS, USP)
RX ONLY
Levothyroxine and Liothyronine (thyroid tablets, USP) for oral use is
a natural preparation derived from
porcine thyroid glands. They contain both tetraiodothyronine sodium
(T4 levothyroxine) and
liothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine
(T4) and 9 mcg liothyronine
(T3) per grain of thyroid (or per 60 mg of the labeled amount of
thyroid). The inactive ingredients are
microcrystalline cellulose, hypromellose, magnesium stearate.
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 liothyronine
(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
o