OCELLA- drospirenone and ethinyl estradiol kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Dostupno od:

Physicians Total Care, Inc.

INN (International ime):

DROSPIRENONE

Sastav:

DROSPIRENONE 3 mg

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

OCELLA is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. Oral contraceptives are highly effective. TABLE II 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 Accidental Pregnancy % of Women Continuing Use At One Year Method Typical Use Perfect Use In clinical efficacy studies of OCELLA of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. The mean age of the subjects was 25.5 ± 4.7 years. The age range was 16 to 37 years. The racial demographic was: 83% Caucasian, 1% Hispanic, 1% Black, <1% Asian, <1% other, <1% missing data, 14% not inquired and <1% unspecified. Pregnancy rates in the clinical trials were less than one p

Proizvod sažetak:

OCELLA Tablets (drospirenone and ethinyl estradiol) are available in  28 tablets ( BLISTER pack)  (NDC 54868-5922-0). Each pack contains 21 active yellow round, unscored, film coated tablets each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol, and 7 inert white round, unscored, film coated tablets. Store at 25° C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

Status autorizacije:

New Drug Application

Svojstava lijeka

OCELLA - DROSPIRENONE AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
OCELLA 28 TABLETS
(DROSPIRENONE AND ETHINYL ESTRADIOL)
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DES CRIPTION
OCELLA provides an oral contraceptive regimen consisting of 21 active
film coated tablets each
containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7
inert film coated tablets. The
inactive ingredients are lactose monohydrate NF, corn starch NF,
modified starch NF, povidone 25000
USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP,
macrogol 6000 NF, talc USP,
titanium dioxide USP, ferric oxide pigment, yellow NF. The inert film
coated tablets contain lactose
monohydrate NF, corn starch NF, povidone 25000 USP, magnesium stearate
NF, hydroxylpropylmethyl
cellulose USP, talc USP, titanium dioxide USP.
Drospirenone
(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,
14,15,15a,16-
hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-6,7:15,16]
cyclopenta[ a]phenanthrene-
17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational
compound and has a molecular weight of
366.5 and a molecular formula of C
H O . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-
yne-3,17-diol) is a synthetic estrogenic compound and has a molecular
weight of 296.4 and a molecular
formula of C
H O . The structural formulas are as follows:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Combination oral contraceptives (COCs) act by suppression of
gonadotropins. Although the primary
mechanism of this action is inhibition of ovulation, other alterations
include changes in the cervical
mucus (which increases the difficulty of sperm entry into the uterus)
and the endometrium (which
reduces the likelihood of implantation).
Drospirenone is a spironolactone analogue with antimineralocorticoid
activity. Preclinical studies in
animals and _in vitro _have shown that drospirenone has no androgenic,
es