JUNEL FE 28 DAY- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

A-S Medication Solutions

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 20 20 40 Implant 0.05 0.05 Injection: depot medroxyprogesterone acetate 0.3 0.3 IUD progesterone T copper T 380A LNg 20 1.5 0.6 0.1 2 0.8 0.1 Condom without spermicides female male 5 3 21 14 Cervical Cap with spermicidal cream or jelly nulliparous parous 9 26 20 40 Periodic abstinence (all methods) 1 to 9 25 Withdrawal 4 19 Female sterilization 0.5 0.5 Male sterilization 0.10 0.15 Adapted from RA Hatcher et al, Reference 7. * The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time)     and who use it consistently and correctly during the first year if they do not stop for any other reason. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do      not stop use for any other reason. *** N/A-Data not available. Oral contraceptives are contraindicated in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Current diagnosis of, or history of, breast cancer, which may be hormone sensitive - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior pill use - Hepatic adenomas or carcinomas - Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

ملخص المنتج:

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].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

JUNEL FE 28 DAY- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS
FUMARATE
A-S MEDICATION SOLUTIONS
----------
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 any therapeutic purpose.
Each light yellow tablet contains norethindrone