Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Aurobindo Pharma Limited
NORETHINDRONE
NORETHINDRONE 0.4 mg
PRESCRIPTION DRUG
Nexesta Fe is indicated for use by females of reproductive potential to prevent pregnancy. Nexesta Fe is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] o Have cerebrovascular disease [see Warnings and Precautions (5.1)] o Have coronary artery disease [see Warnings and Precautions (5.1)] o 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)] o Have uncontrolled hypertension [see Warnings and Precaution
Nexesta Fe (norethindrone and ethinyl estradiol tablets USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets (chewable)) is available in blister packs: The Blister Packs are packed in Pouches (NDC 65862-926-87) and the pouches are packaged in cartons Carton of 1 Pouch NDC 65862-926-87 Carton of 3 Pouches NDC 65862-926-88 Carton of 5 Pouches NDC 65862-926-58 Carton of 72 Pouches NDC 65862-926-97 Each blister pack contains 28 tablets in the following order: Keep out of the reach of children.
Abbreviated New Drug Application
NEXESTA FE- NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE AUROBINDO PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEXESTA FE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXESTA FE. NEXESTA FE (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS (CHEWABLE) AND FERROUS FUMARATE TABLETS (CHEWABLE)) FOR ORAL USE INITIAL U.S. APPROVAL: 1975 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. NEXESTA FE 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 Warnings and Precautions (5.11) 11/2021 INDICATIONS AND USAGE Nexesta Fe is a 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. Tablets may be chewed or swallowed. (2.1) Take tablets in the order directed on the blister pack. (2.1) DOSAGE FORMS AND STRENGTHS Nexesta Fe consists of 28 tablets in the following order (3): 21 white to off-white tablets (active), each containing 0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP 7 brown tablets (non-hormonal placebo), each containing 75 mg ferrous fumarate USP. The ferrous fumarate tablets do not serve any therapeutic purpose. CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems: Stop Nexesta Fe if a thrombotic event occurs. Stop at least 4 weeks before through 2 week Prečítajte si celý dokument