LEVOTHYROXINE SODIUM tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Pieejams no:

Blenheim Pharmacal, Inc.

SNN (starptautisko nepatentēto nosaukumu):

LEVOTHYROXINE SODIUM

Kompozīcija:

LEVOTHYROXINE SODIUM ANHYDROUS .025 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECA

Produktu pārskats:

Levothyroxine Sodium Tablets, USP are round, color coded, partial bisected tablets debossed with JSP and ID Number: STORAGE CONDITIONS 20°C to 25°C (68°F to 77°F) with excursions between 15°C to 30°C (59°F to 86°F) Rx only Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 10/07 MG #18326

Autorizācija statuss:

New Drug Application

Produkta apraksts

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM TABLET
BLENHEIM PHARMACAL, INC.
----------
LEVOTHYROXINE SODIUM TABLETS, USP
CLINICAL PHARMACOLOGY
Thyroid hormone synthesis and secretion is regulated by the
hypothalamic-pituitary-thyroid axis.
Thyrotropin-releasing hormone (TRH) released from the hypothalamus
stimulates secretion of
thyrotropin-stimulating hormone, TSH, from the anterior pituitary.
TSH, in turn, is the physiologic
stimulus for the synthesis and secretion of thyroid hormones,
L-thyroxine (T
) and L-triiodothyronine
(T
), by the thyroid gland. Circulating serum T
and T
levels exert a feedback effect on both TRH
and TSH secretion. When serum T
and T
levels increase, TRH and TSH secretion decrease. When
thyroid hormone levels decrease, TRH and TSH secretion increase.
The mechanisms by which thyroid hormones exert their physiologic
actions are not completely
understood, but it is thought that their principal effects are exerted
through control of DNA
transcription and protein synthesis. T
and T
diffuse into the cell nucleus and bind to thyroid receptor
proteins attached to DNA. This hormone nuclear receptor complex
activates gene transcription and
synthesis of messenger RNA and cytoplasmic proteins.
Thyroid hormones regulate multiple metabolic processes and play an
essential role in normal growth
and development, and normal maturation of the central nervous system
and bone. The metabolic actions
of thyroid hormones include augmentation of cellular respiration and
thermogenesis, as well as
metabolism of proteins, carbohydrates and lipids. The protein anabolic
effects of thyroid hormones are
essential to normal growth and development.
The physiologic actions of thyroid hormones are produced predominately
by T
, the majority of which
(approximately 80%) is derived from T
by deiodination in peripheral tissues.
Levothyroxine, at doses individualized according to patient response,
is effective as replacement or
supplemental therapy in hypothyroidism of any etiology, except
transient hypothyroidism during the
rec