NP THYROID 90- levothyroxine and 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:

Northwind Pharmaceuticals

INN (International Name):

LEVOTHYROXINE

Composition:

LEVOTHYROXINE 57 ug

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. 3. As diagnostic agents in suppression tests to differentiate su

Authorization status:

unapproved drug other

Summary of Product characteristics

NP THYROID 90- LEVOTHYROXINE AND LIOTHYRONINE TABLET
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 90
DESCRIPTION
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
(or per 65 mg of the labeled amount of thyroid). The inactive
ingredients are calcium stearate, dextrose
monohydrate, maltodextrin and mineral oil.
NOTE:
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.
CLINICAL PHARMACOLOGY
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.