국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Mylan Pharmaceuticals Inc.
PRESCRIPTION DRUG
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are 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. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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 e
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets are available in blister packs each containing 28 tablets. The first five white to off white tablets each contain 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol; the next seven light purple tablets each contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol; the next nine purple tablets each contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol; and the last seven (brown) tablets each contain 75 mg ferrous fumarate. Carton of 3 tri-laminated aluminium pouches (NDC 0378-7303-53), Carton of 6 tri-laminated aluminium pouches (NDC 0378-7303-56) each pouch containing blister of 28 tablets. Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Store tablets in blister sleeve when not in use. Keep this and all medication out of the reach of children. REFERENCES AVAILABLE UPON REQUEST The brands listed are trademarks of their respective owners.
Abbreviated New Drug Application
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE MYLAN PHARMACEUTICALS INC. ---------- 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. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS Each white to off white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each purple 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 Norethindrone acetate and ethinyl estradiol tablets are graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide 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 white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17- (acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estr 전체 문서 읽기