Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Allergan, Inc.
NORETHINDRONE ACETATE
NORETHINDRONE ACETATE 1 mg
PRESCRIPTION DRUG
Lo Loestrin® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated. Lo Loestrin 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: • 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 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 inherited or acquired hypercoagulopathies [see W
Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister cards (dispensers) containing 28 tablets: NDC 0430-0420-14 Cartons of 5 blister cards (dispensers) NDC 0430-0420-60 Cartons of 30 blister cards (dispensers) Each blister card (28 tablets) contains in the following order: Store at 25º C (77º F); excursions permitted to 15 - 30º C (59 - 86º F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children.
New Drug Application
LO LOESTRIN FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL AND FERROUS FUMARATE ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LO LOESTRIN FE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LO LOESTRIN FE. LO LOESTRIN FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS) INITIAL U.S. APPROVAL: 1968 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE LO LOESTRIN FE (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE (4) RECENT MAJOR CHANGES Warnings and Precautions (5.2) 04/2022 INDICATIONS AND USAGE Lo Loestrin Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy (1) The efficacy of Lo Loestrin Fe in women with a body mass index of > 35 kg/m has not been evaluated (1, 8.8) DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days (2.1) Take tablets in the order directed on the blister pack (2.1) DOSAGE FORMS AND STRENGTHS Lo Loestrin Fe consists of 28 tablets in the following order (3): 24 blue tablets (active), each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol 2 white tablets (active), each containing 10 mcg ethinyl estradiol 2 brown tablets (non-hormonal placebo), each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases (4) Breast cancer (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) WARNINGS AND PRECAUTIONS Vascular risks: Stop Lo Loe Läs hela dokumentet