Vyfemla

VYFEMLA — norethindrone and ethinyl estradiol
LUPIN LIMITED

Rx only

28 — DAY REGIMEN

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

DESCRIPTION

Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) provides a continuous regimen for oral contraception derived from 21 light peach tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are:

The light peach active Vyfemla (norethindrone and ethinyl estradiol tablets USP) contains 0.4 mg norethindrone and 0.035 mg ethinyl estradiol and contain the following inactive ingredients: FD&C yellow No. 6 (aluminum lake), lactose anhydrous, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. The white tablets in the 28 Day regimen contains only inert ingredients as follows croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

CLINICAL PHARMACOLOGY

Combination oral contraceptives 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 increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

INDICATIONS AND USAGE

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use

Reproduced with permission of the Population Council from J. Trussell, et al: Contraceptive failure in the United States: An update.
Studies in Family Planning, 21(1), January-February 1990.
* The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. † This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. ‡ Combined typical rate for both combined and progestin only. § Combined typical rate for both medicated and nonmedicated IUD.
Method	Lowest Expected *	Typical †
(No contraception)	(85)	(85)
Oral contraceptives
combined	0.1	3‡
progestin only	0.5	3‡
Diaphragm with spermicidal cream or jelly	6	18
Spermicides alone (foam, creams, jellies and vaginal suppositories)	3	21
Vaginal sponge
nulliparous	6	18
multiparous	9	28
IUD	0.8 to 2.0	3§
Condom without spermicides	2	12
Periodic abstinence (all methods)	1 to 9	20
Injectable progestogen	0.3 to 0.4	0.3 to 0.4
Implants
6 capsules	0.04	0.04
2 rods	0.03	0.03
Female sterilization	0.2	0.4
Male sterilization	0.1	0.15