"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
LYBREL (levonorgestrel and ethinyl estradol tablets) 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 for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Table 2: 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.
|% of Women Experiencing an Unintended Pregnancy within the First Year of Use||% of Women Continuing Use at One Year 3|
|Method (1)||Typical Use 1 (2)||Perfect Use 2 (3)||(4)|
| Emergency Contraceptive Pills: The FDA has
concluded that certain combined oral contraceptives containing ethinyl
estradiol and norgestrel or levonorgestrel are safe and effective for
use as postcoital emergency contraception. Treatment initiated within
72 hours after unprotected intercourse reduces the risk of pregnancy by
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
1. 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.
2. 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.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4. 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.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets.
10. 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 6 months of age.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, LYBREL (levonorgestrel and ethinyl estradol tablets) (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of LYBREL (levonorgestrel and ethinyl estradol tablets) is one yellow tablet daily without any tablet-free interval.
It is recommended that LYBREL (levonorgestrel and ethinyl estradol tablets) tablets be taken at the same time each day.
Initiation of Therapy
Instructions for beginning LYBREL (levonorgestrel and ethinyl estradol tablets) are provided in Table 4 below.
|Current contraceptive therapy||LYBREL
|Non hormonal back-up method of birth control needed when correctly starting LYBREL?|
|None||Day 1 of patient's menstrual cycle (during the first 24 hours of her period)||No|
|21-day COC regimen OR
28-day COC regimen
|Day 1 of patient's withdrawal bleed, at the latest 7 days after her last active tablet||No|
|Progestin-only pill||Day after taking a progestin-only pill||Yes, for the first 7 days of LYBREL tablet taking|
|Implant||Day of implant removal||Yes, for the first 7 days of LYBREL tablet taking|
|Injection||Day the next injection is due||Yes, for the first 7 days of LYBREL tablet taking|
If spotting or unscheduled bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her health care professional. The possibility of ovulation increases with each successive day that scheduled yellow tablets are missed. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered. Hormonal contraception must be discontinued if pregnancy is confirmed.
The risk of pregnancy increases with each tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING section.
LYBREL (levonorgestrel and ethinyl estradol tablets) may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.
In the case of first-trimester abortion, if the patient starts LYBREL (levonorgestrel and ethinyl estradol tablets) immediately, additional contraceptive measures are not needed.
LYBREL® (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets are available in a ClickCase® , NDC 0008-1117-30 containing:
28 round, yellow biconvex, film-coated tablet debossed with “W” on one side and “1117” on the other side.
Store at up to 25°Cions permitted to 15-30°C [see USP Controlled Room Temperature].
Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. FDA rev date: 9/15/2008
Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.
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