Generic name: levonorgestrel and ethinyl estradiol
Dosage form: tablets
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Although the occurrence of pregnancy is unlikely if InrovaleTM are 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. InrovaleTM should be discontinued if pregnancy is confirmed.
The dosage of InrovaleTMis one peach (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets 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 to avoid damage to the product.
During the first cycle of medication, the patient is instructed to begin taking InrovaleTM on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (peach) is taken that day. One peach 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 peach active tablets. During the first cycle, contraceptive reliance should not be placed on InrovaleTM until a peach (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 peach 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 peach 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 peach tablets, she should also use another method of non-hormonal back-up contraception until she has taken a peach 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 peach tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled peach tablets are missed. The risk of pregnancy increases with each active (peach) tablet missed.
In the nonlactating mother, InrovaleTMmay 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. Levonorgestrel and ethinyl estradiol tablets may be initiated immediately after a first-trimester abortion; if the patient starts levonorgestrel and ethinyl estradiol tablets immediately, additional contraceptive measures are not needed.