JUNEL FE 1.5/30- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

INN (Διεθνής Όνομα):

NORETHINDRONE ACETATE

Σύνθεση:

NORETHINDRONE ACETATE 1.5 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 medroxyprogesterone acetate 0.3 0.3 IUD progeste

Περίληψη προϊόντος:

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 63187-890-28) . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

JUNEL FE 1.5/30- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND
FERROUS
FUMARATE
PROFICIENT RX LP
----------
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 _
_ FE_ 1.5/30
(Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.
Each brown tablet contains 75 mg ferrous fumarate.)
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.
Each light yellow tablet contains norethindrone acetate
(17α-ethinyl-19-nortestosterone
acetate), 1 mg; ethinyl estradiol
(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 aluminum lake, lactose monohydrate, magnesium
stearate and
pregelatinized starch.
Each pink tablet contains norethindrone acetate
(17α-ethinyl-19-nortestosterone
acetate), 1.5 mg; ethinyl estradiol
(17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30
mcg. Each pink tablet contains the following inactive ingredients:
acacia, compressible
sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate,
magnesium stearate
and pregelatinized starch.
Each brown tablet contains the following ingredients: crospovidone,
ferrous fumarate,
hydrogenated vegetable oil, NF Type I and microcrystalline cellulose.
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C22H28O3 M.W. 340.46
C20H24O2 M.W. 296.40
CLINICAL PHARMAC