TRI-LEGEST FE 28 DAY- norethindrone acetate and ethinyl estradiol kit

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Dostupné z:

Teva Pharmaceuticals USA, Inc.

INN (Medzinárodný Name):

NORETHINDRONE ACETATE

Zloženie:

NORETHINDRONE ACETATE 1 mg

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

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