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Seasonique

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Seasonique

Seasonique

INDICATIONS

Seasonique (levonorgestrel, ethinyl estradiol) ® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.

DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day. The dosage of Seasonique (levonorgestrel, ethinyl estradiol) is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Seasonique (levonorgestrel, ethinyl estradiol) must be taken exactly as directed and at intervals not exceeding 24 hours.

Instruct the patient to begin taking Seasonique (levonorgestrel, ethinyl estradiol) 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 one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a light blue-green tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Seasonique (levonorgestrel, ethinyl estradiol) , following the same schedule: 84 days taking a light blue-green tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue-green tablet daily for 7 consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

For patient instructions regarding missed pills, see FDA-Approved Patient Labeling.

For postpartum women who are not breastfeeding, start Seasonique (levonorgestrel, ethinyl estradiol) no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Seasonique (levonorgestrel, ethinyl estradiol) postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a light blue-green tablet for 7 consecutive days.

HOW SUPPLIED

Dosage Forms And Strengths

Seasonique (levonorgestrel, ethinyl estradiol) tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers, 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 tablets debossed with stylized b on one side and 556 on the other side.

Storage And Handling

How Supplied

Seasonique (levonorgestrel, ethinyl estradiol) tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) 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 tablets debossed with stylized b on one side and 556 on the other side.

Box of 2 Extended-Cycle Tablet Dispensers NDC 51285-087-87

Storage Conditions

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

DURAMED PHARMACEUTICALS, INC., Subsidiary of Barr Pharmaceuticals, Inc. Pomona, New York 10970. Revised July 2010

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

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