"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 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, the IUD, and implants 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 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 OneYear 3|
|Method (1)||Typical Use 1 (2)||Perfect Use 2 (3)||(4)|
|Levonorgestrel Implants (NorplantR)||0.05||0.05||88|
| Lactation Amenorrhea Method: LAM is a highly effective, temporary
method of contraception.9
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 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, Lo/Ovral 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.
The dosage of Lo/Ovral is one tablet daily for 21 consecutive days per menstrual cycle according to prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off).
It is recommended that Lo/Ovral tablets be taken at the same time each day.
During the first cycle of medication, the patient is instructed to take one Lo/Ovral tablet daily for twenty-one consecutive days, beginning on the first day (Day 1 Start) of her menstrual cycle or on the Sunday after her period begins (Sunday Start). (The first day of menstruation is day one.) The tablets are then discontinued for one week (7 days). Withdrawal bleeding should usually occur within 3 days following discontinuation of Lo/Ovral and may not have finished before the next pack is started. (If Lo/Ovral is first taken later than the first day of a menstrual cycle or postpartum, contraceptive reliance should not be placed on Lo/Ovral until after the first seven consecutive days of use and a nonhormonal back-up method of birth control should be used during those 7 days. For Sunday Start: Contraceptive reliance should not be placed on Lo/Ovral until after the first seven consecutive days of use, and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.)
The patient begins her next and all subsequent 21-day courses of Lo/Ovral tablets on the same day of the week that she began her first course, following the same schedule: 21 days on-7 days off. She begins taking her tablets on the 8th day after the last tablet in the previous pack, regardless of whether or not a menstrual period has occurred or is still in progress. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Lo/Ovral. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Lo/Ovral on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Lo/Ovral the next day. If switching from an implant or injection, the patient should start Lo/Ovral on the day of implant removal or the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.
If spotting or breakthrough 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. Although pregnancy is unlikely if Lo/Ovral is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. 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 at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormone contraception should be discontinued if pregnancy is confirmed.
For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.
Any time the patient misses two or more tablets, she should also use another method of contraception until she has taken a tablet daily for seven consecutive days. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled tablets are missed.
Lo/Ovral 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 Lo/Ovral immediately, additional contraceptive measures are not needed.
Lo/Ovral Tablets (0.3 mg norgestrel and 0.03 mg ethinyl estradiol) are available in packages of 6 PILPAK dispensers with 21 tablets each as follows:
NDC 0008-0078, white, round tablet marked "WYETH" and "78".
Store at controlled room temperature 20°C to 25°C (68°F to 77°F).
References available upon request.
Wyeth Laboratories, A Wyeth-Ayerst Company, Philadelphia, PA 19101. Rev 07/03. FDA Rev date: 3/6/2002This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/21/2008
Additional Lo Ovral Information
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