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:

Preferred Pharmaceuticals Inc.

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Junel 21 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

ملخص المنتج:

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 68788-8113-2). 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
PREFERRED PHARMACEUTICALS INC.
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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
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTIONS (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
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.
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Each light yellow tablet contains norethindrone acetate, USP
(17α-ethinyl-19-
nortestosterone acetate), 1 mg; ethinyl estradiol, USP
(17α-ethinyl-1,3,5(10)-estratriene-
3, 17β-diol), 20 mcg. Each light yellow tablet contains the following
inactive ingredients:
acacia, compressible sugar, D&C yellow no. 10 alum