RECOMMENDED DOSE: How to Start DELSIA: Instruct the patient to begin taking DELSIA either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
Day 1 Start: During the first cycle of DELSIA use, instruct the patient to take one yellow DELSIA daily, beginning on Day 1 of her menstrual cycle (the first day of menstruation is Day 1). She should take one yellow DELSIA daily for 21 consecutive days, followed by a 7-day tablet-free interval. DELSIA should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. DELSIA can be taken without regard to meals. If DELSIA is first taken later than the first day of the menstrual cycle, it should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
Sunday Start: During the first cycle of DELSIA use, instruct the patient to take one yellow DELSIA daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow DELSIA daily for 21 consecutive days, followed by 7-day-free interval. DELSIA should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. DELSIA can be taken without regard to meals. DELSIA should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should begin her next and all subsequent 21-day regimens of DELSIA on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow tablets on the next day after 7-day tablet-free interval, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of DELSIA is started later than the day following a 7-day tablet-free interval, the patient should use another method of contraception until she has taken a yellow DELSIA daily for seven consecutive days.
When switching from a different birth control pill: When switching from another birth control pill, DELSIA should be started on the same day that a new pack of the previous oral contraceptive would have been started.
When switching from a method other than a birth control pill: When switching from a transdermal patch or vaginal ring, DELSIA should be started when the next application would have been due. When switching from an injection, DELSIA should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, DELSIA should be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking DELSIA, instruct the patient to continue taking DELSIA by the regimen described as previously mentioned. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.
Although the occurrence of pregnancy is low if DELSIA is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active yellow tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue DELSIA if pregnancy is confirmed.
The risk of pregnancy increases with each active yellow tablet missed. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence.
For postpartum women who do not breastfeed or after a second trimester abortion, start DELSIA no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts DELSIA 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 DELSIA for 7 consecutive days.
Advice in Case of Gastrointestinal Disturbances: In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.
MODE OF ADMINISTRATION: How to Take DELSIA: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive effectiveness, DELSIA must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
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