Enpresse

ENPRESSE- levonorgestrel and ethinyl estradiol
Teva Pharmaceuticals USA, Inc.

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

DESCRIPTION

Each Enpresse® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 pink tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 orange tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and pregelatinized starch. Coloring agents used are as follows: pink, 0.050mg/0.030mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075mg/0.040mg tablets: none; orange, 0.125mg/0.030mg tablets: FD&C Yellow No. 6 Aluminum Lake, 38-42%; and light-green, inert tablets: D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.

Description: Structural FormulaLevonorgestrel, USP MW: 312.45 MF: C21 H28 O2

Description: Structural Formula 2
(click image for full-size original)
Ethinyl Estradiol, USP MW: 296.41 MF: C20 H24 O2

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 I 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 the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD

*
Depending on method (calendar, ovulation, symptothermal, post-ovulation)

Method

Perfect Use

Typical Use

Levonorgestrel implants

0.05

0.05

Male sterilization

0.1

0.15

Female sterilization

0.5

0.5

Depo-Provera®

(injectable progestogen)

0.3

0.3

Oral contraceptives

5

Combined

0.1

NA

Progestin only

0.5

NA

IUD

Progesterone

1.5

2.0

Copper T 380A

0.6

0.8

Condom

(male) without spermicide

3

14

(female) without spermicide

5

21

Cervical cap

Nulliparous women

9

20

Parous women

26

40

Vaginal sponge

Nulliparous women

9

20

Parous women

20

40

Diaphragm with

spermicidal cream or jelly

6

20

Spermicides alone

(foam, creams, jellies, and vaginal suppositories)

6

26

Periodic abstinence (all methods)

1 to 9*

25

Withdrawal

4

19

No contraception (planned pregnancy)

85

85

NA — not available

Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition , NY, NY: Ardent Media, Inc., 1998.

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