Seasonale

The FDA has approved Seasonale, a new choice in oral contraceptives for women for prevention of pregnancy. Seasonale is a 91-day oral contraceptive regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (7 days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets followed by 7 days of placebo tablets). Seasonale contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in already approved oral contraceptives.

Under Seasonale's dosing regimen the number of expected menstrual periods that a woman usually experiences are reduced from once a month to about once every three months. As with the conventional 28-day regimen, women will have their period while taking the placebo tablets.

Although Seasonale users have fewer scheduled menstrual cycles, the data from clinical trials show that many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral contraceptive.

Like other available oral contraceptives, Seasonale is effective for prevention of pregnancy when used as directed. The risks of using Seasonale are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination estrogen and progestin containing contraceptives. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

How Seasonale Works:
To achieve maximum effectiveness, Seasonale 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 dosing regimen for Seasonale is:

Take 1 pink tablet daily for 84 consecutive days
Follow with 7 days of white inactive tablets
Begin taking Seasonale on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first pink tablet is taken that day
Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.
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How To Take Seasonale :
To achieve maximum effectiveness, SEASONALE® 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 dosing regimen for SEASONALE® is:

Take 1 pink tablet daily for 84 consecutive days.
Follow with 7 days of white inactive tablets.
Begin taking SEASONALE® on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first pink tablet is taken that day.

Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.

Seasonale Side Effects:
Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.