"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"...
Seasonale® (levonorgestrel, ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Seasonale® (levonorgestrel, ethinyl estradiol) during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use.
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 Norplant Implant System, depends 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 Useat One Year3|
|Method (1)||Typical Use1 (2)||Perfect Use2 (3)||(4)|
|Copper T 380A||0.8||0.6||78|
|Norplant and Norplant-2||0.05||0.05||88|
|Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the riskof pregnancy by at least 75%. 9|
|Lactational 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, Kowal 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 unintended 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 unintended 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 percentages of women 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 percentage 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 Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
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 six months of age.
DOSAGE AND ADMINISTRATION
Although the occurrence of pregnancy is unlikely if Seasonale® (levonorgestrel, ethinyl estradiol) is taken according to directions, if withdrawal bleeding does not occur while taking white (inactive) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period. Seasonale® (levonorgestrel, ethinyl estradiol) should be discontinued if pregnancy is confirmed.
The dosage of Seasonale® (levonorgestrel, ethinyl estradiol) is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. To achieve maximum contraceptive effectiveness, Seasonale® (levonorgestrel, ethinyl estradiol) must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. The tablets should not be removed from the protective blister packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient.
During the first cycle of medication, the patient is instructed to begin taking Seasonale® (levonorgestrel, ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 84 consecutive days, followed by 7 days on which a white (inert) tablet is taken. Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets. During the first cycle, contraceptive reliance should not be placed on Seasonale® (levonorgestrel, ethinyl estradiol) until a pink (active) tablet has been taken daily for 7 consecutive days and a non-hormonal backup method of birth control (such as condoms or spermicide) 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 91-day courses of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which pink tablets are taken followed by 7 days on which white tablets are taken. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal backup method of birth control until she has taken a pink tablet daily for 7 consecutive days.
If spotting or breakthrough bleeding occurs , the patient is instructed to continue on the same regimen. This type of bleeding may be transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider.
For patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING. Any time the patient misses two or more pink tablets, she should also use another method of non-hormonal back-up contraception until she has taken a pink tablet daily for seven consecutive days. If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled pink tablets are missed. The risk of pregnancy increases with each active (pink) tablet missed.
In the nonlactating mother, Seasonale® (levonorgestrel, ethinyl estradiol) may be initiated no earlier than day 28 postpartum, for contraception due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (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, the possibility of ovulation and conception prior to initiation of medication should be considered. Seasonale® (levonorgestrel, ethinyl estradiol) may be initiated immediately after a first-trimester abortion; if the patient starts Seasonale® (levonorgestrel, ethinyl estradiol) immediately, additional contraceptive measures are not needed.
Seasonale® (levonorgestrel, ethinyl estradiol) tablets (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg are available in Extended-Cycle Tablet Dispensers (NDC 51285-058-66), each containing a 13-week supply of tablets: 84 pink tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 white inert tablets. The active pink tablets are round, film-coated, biconvex, unscored tablets with a debossed S on one side and 62 on the other side. The inert tablets are white, round, biconvex, unscored tablet debossed with S on one side and 197 on the other side.
Store at controlled room temperature 20°-25° C (68°-77° F) [See USP].
References available upon request.
MANUFACTURED BY: DURAMED PHARMACEUTICALS, INC. A subsidiary of Barr Laboratories, Inc. Pomona, NY 10970-0519. Revised September 2003. FDA rev date: 9/5/2003
Last reviewed on RxList: 11/18/2008
This monograph has been modified to include the generic and brand name in many instances.
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