Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY)
Lupin Pharmaceuticals, Inc.
ETHINYL ESTRADIOL
ETHINYL ESTRADIOL 0.035 mg
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lestu allt skjalið