GIANVI- drospirenone and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MedVantx, Inc.

INN (International Name):

DROSPIRENONE

Composition:

DROSPIRENONE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gianvi 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 unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Gianvi is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Gianvi for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other featur

Product summary:

Gianvi (drospirenone and ethinyl estradiol) Tablets are available in packages of 3 BLISTER packs (NDC 0093-5423-58). Each pack contains 24 active light pink round, unscored, film-coated tablets debossed with a "DS" in a regular hexagon on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol, and 4 inert white round, unscored, film-coated tablets debossed with a "DP" in a regular hexagon on one side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

GIANVI- DROSPIRENONE AND ETHINYL ESTRADIOL
MEDVANTX, INC.
----------
GIANVI
(DROSPIRENONE AND ETHINYL ESTRADIOL) TABLETS
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES
DESCRIPTION
Gianvi
provides an oral contraceptive regimen consisting of 24 active film
coated tablets each
containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol
stabilized by betadex as a clathrate
(molecular inclusion complex) and 4 inert film coated tablets. Other
ingredients are lactose
monohydrate NF, corn starch NF, magnesium stearate NF, hypromellose
USP, talc USP, titanium
dioxide USP, ferric oxide pigment, red NF. The inert film coated
tablets contain lactose monohydrate
NF, corn starch NF, povidone 25000 USP, magnesium stearate NF,
hypromellose 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: TM
TM
24
30
3
20
24
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Oral Contraception
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,
estrogenic, glucoco