Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Mylan Pharmaceuticals Inc.
NORETHINDRONE ACETATE
NORETHINDRONE ACETATE 1 mg
PRESCRIPTION DRUG
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by women to prevent pregnancy [see Clinical Studies (14)] . The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated. Do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets are available in blister packs containing 28 tablets: NDC 0378-7301-53 Cartons of 3 blister packs Each blister pack (28 tablets) contains in the following order:
Abbreviated New Drug Application
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE MYLAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1968 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ • • RECENT MAJOR CHANGES Contraindications (4) 08/2017 Warnings (5.3) 08/2017 INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are a progestin/estrogen COC indicated for use by women to prevent pregnancy. (1) The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of > 35 kg/m has not been evaluated. (1, 8.8) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets consist of 28 tablets in the following order (3): • • CONTRAINDICATIONS • • • • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS INC. AT 1-877-446-3679 (1-877- 4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • USE IN SPECIFIC POPULATIONS • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 2/2018 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 How to Start Norethindrone Acetate and Ethinyl Estradiol Tablets and Lees het volledige document