LOESTRIN 21 DAY- norethindrone acetate and ethinyl estradiol tablet LOESTRIN FE 28 DAY- norethindrone acetate and ethinyl estra

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Teva Women's Health LLC

INN (nume internaţional):

NORETHINDRONE ACETATE

Compoziție:

NORETHINDRONE ACETATE 1 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

LOESTRIN 21 and LOESTRIN Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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 which they are used. Correct and consistent use of methods can result in lower failure rates. % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical** (No contraception) (85) (85) Oral contraceptives combined progestin only 0.1 0.5 3 N/A*** N/A*** Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge nulliparous parous 9

Rezumat produs:

LOESTRIN 1/20 (21 Tablets) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets, USP) are packaged in cartons of five blister cards. Each card contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 977 on the other side. (NDC 51285-131-97) . LOESTRIN Fe 1/20 (28 Tablets) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets, USP, and ferrous fumarate tablets) are packaged in cartons of five blister cards. Each card contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 977 on the other side and 7 brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side. Each brown tablet contains 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 51285-125-70) . LOESTRIN 1.5/30 (21 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP) are packaged in cartons of five blister cards. Each card contains 21 pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 978 on the other side. (NDC 51285-127-97) . LOESTRIN Fe 1.5/30 (28 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP, and ferrous fumarate tablets) are packaged in cartons of five blister cards. Each card contains 21 pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 978 on the other side and 7 brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side. Each brown tablet contains 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 51285-128-70) . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LOESTRIN 21 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
LOESTRIN FE 28 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
TEVA WOMEN'S HEALTH LLC
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LOESTRIN 21 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
LOESTRIN FE 28 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
LOESTRIN 21 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
LOESTRIN 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate, USP and
20 mcg ethinyl
estradiol, USP.)
LOESTRIN 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate, USP and 30
mcg ethinyl
estradiol, USP.)
LOESTRIN FE 28 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY
LOESTRIN FE 1/20
(Each light yellow tablet contains 1 mg norethindrone acetate, USP and
20 mcg ethinyl
estradiol, USP. Each brown tablet contains 75 mg ferrous fumarate,
USP.)
LOESTRIN FE 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate, USP and 30
mcg ethinyl
estradiol, USP. Each brown tablet contains 75 mg ferrous fumarate,
USP.)
RX ONLY
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination 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 LOESTRIN, are contraindicated in women
who are over
35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
LOESTRIN 21 AND LOESTRIN FE 28 are progestogen-estrogen combinations.
LOESTRIN FE 1/20 and 1.5/30: Each provides 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, a