"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"...
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as OVCON (norethindrone and ethinyl estradiol tablets) 50, 28-Day, which contain 50 mcg of estrogen, should not be used unless medically indicated.
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
|Diaphragm with spermicidal cream or jelly||6||18|
|Spermicides alone (foam, creams, jellies and vaginal suppositories)||3||21|
|Condom without spermicides||2||12|
|Periodic abstinence (all methods)||1-9||20|
|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' men expected to experience an accidental pregnancybest guess of the percentage of wo 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.
DOSAGE AND ADMINISTRATION
The following is a summary of the instructions given to the patient in the "HOW TO TAKE THE PILL" section of the DETAILED PATIENT PACKAGE INSERT.
The patient is given instructions in five (5) categories.
- IMPORTANT POINTS TO REMEMBER: The patient is told (a) that she should take one pill every day at the same time, (b) many women have spotting or light bleeding or gastric distress during the first one to three cycles, (c) missing pills can also cause spotting or light bleeding, (d) she should use a back-up method for contraception if she has vomiting or diarrhea or takes some concomitant medications, and/or if she has trouble remembering the pill, (e) if she has any other questions, she should consult her physician.
- BEFORE SHE STARTS TAKING HER PILLS: She should decide what time of day she wishes to take the pill, check whether her pill pack has 21 or 28 pills, and note the order in which she should take the pills (diagrammatic drawings of the pill pack are included in the patient insert).
- WHEN SHE SHOULD START THE FIRST PACK: The Day-One start is listed as the first choice and the Sunday start (the Sunday after her period starts) is given as the second choice. If she uses the Sunday start she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills.
- WHAT TO DO DURING THE CYCLE: The patient is advised to take one pill at the same time every day until the pack is empty. If she is on a 21-day regimen, she should wait seven days to start the next pack. If she is on the 28-day regimen, she should start the next pack the day after the last inactive tablet and not wait any days between packs.
- WHAT TO DO IF SHE MISSES A PILL OR PILLS: The patient is given instructions about what she should do if she misses one, two or more than two pills at varying times in her cycle for both the Day-One and the Sunday start. The patient is warned that she may become pregnant if she has unprotected intercourse in the seven days. To avoid this, she must use another birth control method such as condom, foam, or sponge in these seven days.
OVCON® 50 (norethindrone and ethinyl estradiol tablets, USP) is available in 28-day regimens. Each package contains 21 round, yellow tablets of 1.0 mg norethindrone and 0.05 mg ethinyl estradiol, imprinted with WC on one side and 585 on the other. Each capsule shaped, green tablet in the 28-day regimen contains inert ingredients and is imprinted with WC on one side and 850 on the other.
OVCON (norethindrone and ethinyl estradiol tablets) ® 50, 28-Day
N 0430-0585-14 Carton of 6 blister cards (dispensers)
Store below 30º C (86º F).
References are available upon request.
Manufactured by: Warner Chilcott Company, Inc. Fajardo, PR 00738. Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866. 1-800-521-8813. Revised: July 2008. FDA rev date: 07/22/08
Last reviewed on RxList: 8/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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