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)
Teva Pharmaceuticals USA, Inc.
NORETHINDRONE ACETATE
NORETHINDRONE ACETATE 1 mg
PRESCRIPTION DRUG
Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with wh
Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is packaged in cartons of five tablet dispensers of 28 tablets each. Each tablet dispenser contains five light pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 711 on the other side each containing 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol; seven light yellow, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 712 on the other side each containing 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol; nine light blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 713 on the other side each containing 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol; and seven brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side each containing 75 mg ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. NDC 0555-9032-70 Carton of 5 Tablet Dispensers Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Store tablets inside pouch when not in use. REFERENCES AVAILABLE UPON REQUEST . Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. G 3/2023
Abbreviated New Drug Application
TRI-LEGEST FE 28 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TEVA PHARMACEUTICALS USA, INC. ---------- TRI-LEGEST FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS*) *FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR SIDE EFFECTS FROM COMBINED ORAL CONTRACEPTIVE (COC) USE. THIS RISK INCREASES WITH AGE, PARTICULARLY IN WOMEN OVER 35 YEARS OF AGE, AND WITH THE NUMBER OF CIGARETTES SMOKED. FOR THIS REASON, COCS, INCLUDING NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, ARE CONTRAINDICATED IN WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE. TRI-LEGEST FE (Each light pink tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol; each brown tablet contains 75 mg ferrous fumarate.) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION TRI-LEGEST FE (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. TRI-LEGEST FE provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non- hormonal, and do not serve any therapeutic purpose. Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19- norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna- 1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: c Lees het volledige document