LEVOXYL- levothyroxine sodium tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Pfizer Laboratories Div Pfizer Inc

INN (الاسم الدولي):

LEVOTHYROXINE SODIUM

تركيب:

LEVOTHYROXINE SODIUM ANHYDROUS 25 ug

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression LEVOXYL is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. Limitations of Use : - LEVOXYL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with LEVOXYL may induce hyperthyroidism [see Warnings and Precautions (5.4)] . - LEVOXYL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)] . Risk Summary Experience with levothyroxine use in pregnant women, including d

ملخص المنتج:

LEVOXYL (levothyroxine sodium) tablets are oval, color-coded and, potency marked available as follows: STORAGE CONDITIONS Store between 68°F–77°F (20°C–25°C) with excursions permitted between 59°F–86°F (15°C–30°C). Store LEVOXYL away from heat, moisture, and light.

الوضع إذن:

New Drug Application

خصائص المنتج

LEVOXYL- LEVOTHYROXINE SODIUM TABLET
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOXYL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVOXYL.
LEVOXYL (LEVOTHYROXINE SODIUM) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THYROID HORMONES, INCLUDING LEVOXYL, SHOULD NOT BE USED FOR THE
TREATMENT OF OBESITY OR FOR WEIGHT
LO S S .
DOSES BEYOND THE RANGE OF DAILY HORMONAL REQUIREMENTS MAY PRODUCE
SERIOUS OR EVEN LIFE-THREATENING
MANIFESTATIONS OF TOXICITY (6, 7.7, 10).
INDICATIONS AND USAGE
LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients
for:
Hypothyroidism: As replacement in primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) congenital or
acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression:
As an adjunct to surgery and radioiodine
therapy in the management of well-differentiated thyroid cancer. (1)
Limitations of Use:
-
-
DOSAGE AND ADMINISTRATION
Administer once daily, on an empty stomach, one-half to one hour
before breakfast with a full glass of water. (2.1)
Administer at least 4 hours before or after drugs that are known to
interfere with absorption. (2.1)
Evaluate the need for dose adjustments when regularly administering
within one hour of certain foods that may affect
absorption. (2.1)
Starting dose depends on a variety of factors, including age, body
weight, cardiovascular status, concomitant medical
conditions (including pregnancy), concomitant medications,
co-administered food, and the specific nature of the
condition being treated. Peak therapeutic effect may not be attained
for 4 to 6 weeks. (2.2)
See full prescribing information for dosing in specific patient
populations. (2.3)
Adequacy of therapy determined with periodic monitoring of TSH and/or
T4 as well as clinical status.