THYROLAR- liothyronine sodium, levothyroxine sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

liothyronine sodium (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V), LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Available from:

Allergan, Inc.

INN (International Name):

liothyronine sodium

Composition:

LIOTHYRONINE 3.1 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Thyrolar Tablets are indicated: - 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 ). - As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, sub-acute or chronic Iymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer. Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adr

Product summary:

Thyrolar Tablets (Liotrix Tablets, USP) are available in five potencies coded as follows: Supplied in bottles of 100, two-layered compressed tablets. Tablets should be stored at cold temperature, between 36˚F and 46˚F (2˚C and 8˚C) in a tight, light- resistant container. Note: (T3 liothyronine sodium is approximately four times as potent as T4 thyroxine on a microgram for microgram basis.) Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. THYROLAR® is a registered trademark of Allergan Sales, LLC. Allergan® and its design are trademarks of Allergan, Inc. Content Updated: June 2018 v.1.0USPI0040

Authorization status:

New Drug Application

Summary of Product characteristics

THYROLAR- LIOTHYRONINE SODIUM, LEVOTHYROXINE SODIUM TABLET
ALLERGAN, INC.
----------
THYROLAR TABLETS (LIOTRIX TABLETS, USP)
RX ONLY
CONTENT UPDATED: JUNE 2018
DESCRIPTION
Thyrolar Tablets (Liotrix Tablets, USP) contain triiodothyronine (T
liothyronine) sodium and
tetraiodothyronine (T levothyroxine) sodium in the amounts listed in
the “HOW SUPPLIED” section.
(T liothyronine sodium is approximately four times as potent as T
thyroxine on a microgram for
microgram basis.)
The inactive ingredients are calcium phosphate, colloidal silicon
dioxide, corn starch, lactose, and
magnesium stearate. The tablets also contain the following dyes:
Thyrolar ¼ - FD&C Blue #1 and
FD&C Red #40; Thyrolar ½ - FD&C Red #40 and D&C Yellow #10; Thyrolar
1 - FD&C Red #40;
Thyrolar 2 - FD&C Blue #1, FD&C Red #40, and D&C Yellow #10; Thyrolar
3 - FD&C Red #40 and
D&C Yellow #10.
STRUCTURAL FORMULAS
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 (T ) per gram of gland, and
®
3
4
3
4
The normal thyroid gland contains approximately 200 mcg of
levothyroxine (T ) per gram of