SYNTHROID 100 MCG TABLETS

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

LEVOTHYROXINE SODIUM

Disponibil de la:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

Codul ATC:

H03AA01

Forma farmaceutică:

TABLETS

Compoziție:

LEVOTHYROXINE SODIUM 100 MCG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

ABBVIE INC., USA

Zonă Terapeutică:

LEVOTHYROXINE SODIUM

Indicații terapeutice:

Hypothyroidism, Pituitary TSH Suppression

Data de autorizare:

2018-05-31

Caracteristicilor produsului

PRESCRIBING INFORMATION
SYNTHROID
® (LEVOTHYROXINE SODIUM) TABLETS
50MCG, 100MCG
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
DOSAGE
FORM/STRENGTH
CLINICALLY RELEVANT NON-MEDICINAL INGREDIENTS
Oral
Tablet / 50 mcg,
100 mcg.
Lactose monohydrate, confectioner’s sugar, Acacia
low peroxide, povidone, magnesium sterarate and
talc.
Colour additives (only at the 100 mcg strength)
_For a complete listing see DOSAGE FORMS, _
_COMPOSITION AND PACKAGING section._
INDICATIONS AND CLINICAL USE
SYNTHROID
®
(levothyroxine sodium tablets) is indicated for the following
indications: Hypothyroidism,
Pituitary TSH Suppression:
HYPOTHYROIDISM
●
May be resulted from primary hypothyroidism due to thyroid
dysfunction, primary atrophy, or
partial or total absence of thyroid gland, or from the effects of
surgery, radiation or drugs, with or
without the presence of goiter, including subclinical hypothyroidism;
secondary (pituitary)
hypothyroidism; and tertiary (hypothalamic) hypothyroidism.
PITUITARY TSH SUPPRESSION

might be needed 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
conjunction with surgery and radioactive iodine therapy in the
management of thyrotropin-dependent
well-differentiated papillary or follicular carcinoma of the thyroid
CONTRAINDICATIONS
SYNTHROID
®
(levothyroxine sodium tablets) is contraindicated in:
●
Patients with an apparent hypersensitivity to thyroid hormones or any
of the inactive
product
constituents. For a complete listing of non-medicinal ingredients, see
the
DOSAGE FORMS,
COMPOSITION AND PACKAGING section. (Note: The 50 mcg tablet is
formulated without
colour additives for patients who are sensitive to dyes.) There
is no well-documented evidence
of true allergic or idiosyncratic reactions to thyroid
hormone.
●
Patients with untreated subclinical thyrotoxicosis (suppressed serum
thyroid-stimulating
hormone [TSH] with normal L-triiodothyronine/liothyr