ZOVIA 1/50E-28 ethynodiol diacetate and ethinyl estradiol

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ETHYNODIOL DIACETATE (UNII: 62H10A1236) (ETHYNODIOL - UNII:9E01C36A9S)

Dostupné z:

Actavis Pharma, Inc.

INN (Medzinárodný Name):

ETHYNODIOL DIACETATE

Zloženie:

ETHYNODIOL DIACETATE 1 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ZOVIA 1/50E-28- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
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_ZOVIA 1/50E-28_
(ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP)
REVISED: MAY 2017
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
_Zovia 1/50E-28_. Each pink tablet contains 1 mg of ethynodiol
diacetate and 50 mcg of ethinyl estradiol,
and the inactive ingredients include lactose (anhydrous), magnesium
stearate, microcrystalline cellulose,
polacrilin potassium, and povidone. In addition, the coloring agents
are D&C Red No. 30 Aluminum
Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the
Zovia 1/50E-28 package is a
placebo containing no active ingredients, and the inactive ingredients
include lactose (anhydrous),
magnesium stearate and microcrystalline cellulose.
The chemical name for ethynodiol diacetate is
19-Nor-17α-pregn-4-en-20-yne-3β,17-diol diacetate, and
for ethinyl estradiol it is
19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
The structural formulas are as follows:
Therapeutic class: Oral contraceptive.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act primarily by suppression of
gonadotropins. Although the primary
mechanism of this action is inhibition of ovulation, other alterations
in the genital tract, including
changes in the cervical mucus (which increase the difficulty of sperm
entry into the uterus) and the
endometrium (which may reduce the likelihood of implantation) may also
contribute to contraceptive
effectiveness.
INDICATIONS AND USAGE
Zovia 1/50E is indicated for the prevention of pregnancy in women who
elect to use oral contraceptives
as a method of contraception. Oral contraceptive products such as
Zovia 1/50E, which contain 50 mcg
of estrogen, should not be used unless medically indicated.
Oral contraceptives are highly effective. Table 1 lists the typical
accidental pregnancy rates for users
of combination oral contraceptives and other methods of contra