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Drug Information for SEASONIQUETM (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg (DURAMED PHARMACEUTICALS, INC.): DOSAGE AND ADMINISTRATION
- INDICATIONS AND USAGE
- INFORMATION FOR THE PATIENT
- ADVERSE REACTIONS
- NONCONTRACEPTIVE HEALTH BENEFITS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- DETAILED PATIENT LABELING
- Diseases/Conditions Related to SEASONIQUETM (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg (DURAMED PHARMACEUTICALS, INC.)
- External Links Related to SEASONIQUETM (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg (DURAMED PHARMACEUTICALS, INC.)
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.
- Drug Information Provided by National Library of Medicine (NLM).