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Seasonique (Levonorgestrel / Ethinyl Estradiol / Ethinyl Estradiol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

SeasoniqueTM tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Clinical Studies

PSE-301 was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of SeasoniqueTM for approximately 1 year (four 91-day SeasoniqueTM extended cycles). A total of 1,006 sexually active adult women of childbearing potential, 18 to 40 years of age, were treated and completed 2,488 SeasoniqueTM 91-day cycles. The principal cohort for efficacy included only patients 18 to 35 years of age who completed at least one 91-day cycle treatment cycle. Cycles in which another form of birth control was used (including condoms) were excluded from the efficacy analysis. The overall Pearl Index was 1.77, based on 7 pregnancies in 1,578 completed 91-day treatment cycles.

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 Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
Method

(1)
Typical Use

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)

Perfect Use

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)


(4)
ChanceThe percentages 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 1 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.8585
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640
Periodic abstinence2563
Calendar9
Ovulation method3
Sympto-thermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2
Post-ovulation1
Withdrawal194
CapWith spermicidal cream or jelly.
Parous women402642
Nulliparous women20956
Sponge
Parous women402042
Nulliparous women20956
Diaphragm20656
CondomWithout spermicides.
Female (Reality)21556
Male14361
Pill571
Progestin only0.5
Combined0.1
IUD:
Progesterone T2.01.581
Copper T 380A0.80.67
LNg 200.10.181
Norplant and Norplant-20.050.0588
Female sterilization0.50.5100
Male sterilization0.150.10100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.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).
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.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.

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.

DOSAGE AND ADMINISTRATION

Although the occurrence of pregnancy is unlikely if Seasonique™ is taken according to directions, if withdrawal bleeding does not occur while taking yellow (ethinyl estradiol) 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. Seasonique™ should be discontinued if pregnancy is confirmed.

The dosage of Seasonique™ is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by 7 days of yellow ethinyl estradiol tablets. To achieve maximum contraceptive effectiveness, Seasonique™ 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. 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 Seasonique™ on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light blue-green tablet is taken that day. One light blue-green tablet should be taken daily for 84 consecutive days, followed by 7 days of yellow tablets. Withdrawal bleeding should occur during the 7 days of yellow tablets. During the first cycle, contraceptive reliance should not be placed on Seasonique™ until a light blue-green tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spersmicides) 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 light blue-green tablets are taken followed by 7 days on which yellow 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 back-up method of birth control until she has taken a light blue-green 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 light blue-green tablets, she should also use another method of non-hormonal back-up contraception until she has taken a light blue-green tablet daily for seven consecutive days. If the patient misses one or more yellow tablets, she is still protected against pregnancy provided she begins taking light blue-green tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled light blue-green tablets are missed. The risk of pregnancy increases with each active (light blue-green) tablet missed.

In the nonlactating mother, SeasoniqueTM may be initiated for contraception no earlier than day 28 postpartum, 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. SeasoniqueTM may be initiated immediately after a first-trimester abortion; if the patient starts SeasoniqueTM immediately, additional contraceptive measures are not needed.

HOW SUPPLIED

SeasoniqueTM tablets (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg are available in Extended-Cycle Tablet Dispensers (NDC 51285-087-87), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with (stylized b) on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablet debossed with (stylized b) on one side and 556 on the other side.

STORAGE

Store at 20° to 25° C (68° to77° F) [See USP Controlled Room Temperature].

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