JUNEL 21 DAY- norethindrone acetate and ethinyl estradiol tablet JUNEL FE 28 DAY- norethindrone acetate and ethinyl estradiol a

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

INN (שם בינלאומי):

NORETHINDRONE ACETATE

הרכב:

NORETHINDRONE ACETATE 1 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Junel21 and Junel 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

leaflet_short:

Junel® 1/20 (21 Tablets ) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets, USP) are packaged in cartons of three 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 0555-9025-42). Junel® 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 six 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 0555-9026-58). Junel® 1.5/30 (21 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP) are packaged in cartons of three 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 0555-9027-42). Junel® 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 six 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 0555-9028-58). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

JUNEL 21 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
JUNEL FE 28 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS
FUMARATE
TEVA PHARMACEUTICALS USA, INC.
----------
JUNEL 21 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
JUNEL FE 28 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
JUNEL 21 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
JUNEL
1/20
(Each light yellow tablet contains 1 mg norethindrone acetate, USP and
20 mcg ethinyl
estradiol, USP.)
JUNEL
1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate, USP and 30
mcg ethinyl
estradiol, USP.)
JUNEL
FE 28 DAY
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY
JUNEL
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.)
JUNEL
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 Junel, are contraindicated in women who
are over 35
years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
JUNEL 21 AND JUNEL
Fe 28 are progestogen-estrogen combinations.
JUNEL 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, are
non-hormonal, and do not serve an