NORGESTIMATE AND ETHINYL ESTRADIOL- norgestimate and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY)

Disponível em:

Lupin Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 0.035 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)]. Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. 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 WARNINGS AND PRECAUTIONS (5.1)] Have uncontrolled hypertension [see WARNI

Resumo do produto:

Norgestimate and ethinyl estradiol tablets USP are available in a wallet pack (NDC 68180-840-11) containing 28 tablets packed in a pouch (NDC 68180-840-11). Such three pouches are packaged in a carton (NDC 68180-840-13). Each wallet (28 tablets) contains in the following order: Keep out of reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NORGESTIMATE AND ETHINYL ESTRADIOL - NORGESTIMATE AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NORGESTIMATE AND ETHINYL ESTRADIOL TABLET IS 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
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets USP are estrogen/progestin
COCs, indicated for use by women to prevent
pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the wallet. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
Norgestimate and ethinyl estradiol tablets consist of 28 round,
biconvex, coated tablets in the following order (3):
21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg
ethinyl estradiol
7 green tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pre gnancy(4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems : Stop
norgestimate and ethinyl estradiol tablets if a
thrombotic event occurs. Stop at least 4 weeks before and through 2
wee