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 corn starch. Coloring agents used are as follows: pink, 0.050 mg/0.030 mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075 mg/0.040 mg tablets: none; orange, 0.125 mg/0.030 mg 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.
Levonorgestrel, USP MW: 312.45 MF: C21 H28 O2
Ethinyl Estradiol, USP MW: 296.40 MF: C20 H24 O2CLINICAL PHARMACOLOGY
Mechanism of Action
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
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
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 *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition , NY, NY: Ardent Media, Inc., 1998. |
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