Zovia 1/35

ZOVIA 1/35- ethynodiol diacetate and ethinyl estradiol
Mayne Pharma Inc.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows:

Ethynodiol Diacetate, USP

Ethynodiol Diacetate structural formula
(click image for full-size original)

C24 H32 O4 M.W. 384.51

Ethinyl Estradiol, USP

Ethinyl Estradiol structural formula
(click image for full-size original)

C20 H24 O2 M.W. 296.40

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 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is 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 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES.
*
Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
§
The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
Foams, creams, gels, vaginal suppositories, and vaginal film.
#
Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
Þ
With spermicidal cream or jelly.
ß
Without spermicides.
à
The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).
è
However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.

% of Women Experiencing an

Unintended Pregnancy

Within the First Year of Use

% of Women Continuing Use

at One Year *

Method

(1)

Typical Use

(2)

Perfect Use

(3)

(4)

Chance §

85

85

Spermicides

26

6

40

Periodic abstinence

25

63

Calendar

9

Ovulation method

3

Sympto-thermal #

2

Post-ovulation

1

Withdrawal

19

4

Cap Þ

Parous women

40

26

42

Nulliparous women

20

9

56

Sponge

Parous women

40

20

42

Nulliparous women

20

9

56

Diaphragm Þ

20

6

56

Condom ß

Female (Reality®)

21

5

56

Male

14

3

61

Pill

5

71

Progestin only

0.5

Combined

0.1

IUD

Progesterone T

2

1.5

81

Copper T 380A

0.8

0.6

78

LNg 20

0.1

0.1

81

Injection (Depo-Provera®)

0.3

0.3

70

Implant (Norplant® and

Norplant-2®)

0.05

0.05

88

Female sterilization

0.5

0.5

100

Male sterilization

0.15

0.1

100

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.à

Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.è

Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998, in press.1

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