LEVONORGESTREL AND ETHINYL ESTRADIOL kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Доступна с:

Acella Pharmaceuticals

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic disease. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] . Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] . Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] . Have cerebrovascular disease [see Warnings and Precautions (5.1)] . Have coronary artery disease [see Warnings and Precautions (5.1)] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warning

Обзор продуктов:

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are available in a blister pack containing 28 tablets arranged in 3 rows of 7 active tablets and 1 row of inactive tablets, as follows: Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are available in the following configurations: Carton of one 1-cycle blister pack (NDC 42192-623-28) Carton of three 1-cycle blister packs (NDC 42192-623-03) Keep out of the reach of children.

Статус Авторизация:

New Drug Application

Характеристики продукта

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
ACELLA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL AND
ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL AND ETHINYL
ESTRADIOL TABLETS
AND FERROUS BISGLYCINATE TABLETS.
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE
TABLETS FOR
ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1997
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE
TABLETS ARE
CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. ( 4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVES (COC) USE. ( 4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.11) 04/2022
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous
bisglycinate tablets are progestin/estrogen
COC indicated for use by females of reproductive potential to prevent
pregnancy. ( 1)
DOSAGE AND ADMINISTRATION
Take one tablet by mouth at the same time every day. ( 2.1)
Take tablets in the order directed on the blister pack. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous
bisglycinate tablets consist of 28 tablets in
the following order ( 3):
21 orange tablets (active), each containing 0.1 mg levonorgestrel and
0.02 mg ethinyl estradiol.
7 blue tablets (inactive placebo) each containing ferrous bisglycinate
36.5 mg. The ferrous bisglycinate
tablets do not serve any therapeutic purpose. ( 3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases ( 4)
Liver tumors or liver disease ( 4)
Undiagnosed abnormal uterine bleeding ( 4)
Pregnancy ( 4)
Breast cancer ( 4)
Hypersensitivity of any of the components ( 4)
Co-administration with He