Nikki

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Tablets must be taken in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Nikki 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 and PMDD effectiveness, Nikki must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Nikki Instruct the patient to begin taking Nikki 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 Nikki use, instruct the patient to take one pink Nikki daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki 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. Nikki can be taken without regard to meals. If Nikki is first taken later than the first day of the menstrual cycle, Nikki 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 Nikki use, instruct the patient to take one pink Nikki daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki 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. Nikki can be taken without regard to meals. Nikki 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 28-day regimens of Nikki on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Nikki is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a pink Nikki daily for seven consecutive days. When switching from a different birth control pill When switching from another birth control pill, Nikki 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, Nikki should be started when the next application would have been due. When switching from an injection, Nikki should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Nikki should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Nikki, instruct the patient to continue taking Nikki by the regimen described above. 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 Nikki 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 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 Nikki if pregnancy is confirmed. The risk of pregnancy increases with each active pink tablet missed. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start Nikki no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Nikki 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 Nikki for 7 consecutive days. 2.3 Missed Doses Table 1: Instructions for Nikki Missed Doses If one light pink active tablet is missed Take the missed active tablet as soon as possible. Take the next tablet at the regular time. This means two tablets may be taken in one day. A back-up birth control method is not required if the patient has sex. If two light pink active tablets in a row are missed in Week 1 or Week 2 Take two active tablets as soon as possible and two tablets the next day. Then take one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two light pink active tablets in a row are missed in Week 3 or Week 4 Day 1 Start : Throw out the rest of the tablet pack and start a new pack that same day. Sunday Start : Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant. If three or more light pink active tablets in a row are missed during any week Day 1 Start : Throw out the rest of the tablet pack and start a new pack that same day. Sunday Start : Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. The patient could become pregnant if they have sex in the 7 days after they restart their tablets. They must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. They should call their healthcare provider if they miss their period, because they might be pregnant. If any of the four white inactive tablets are missed in Week 4 Throw away the tablets that were missed. Keep taking one tablet each day until the pack is empty. They do not need a back-up method. Finally, if they are still not sure what to do about the tablets they have missed: Use nonhormonal contraception (such as condoms and spermicides) anytime they have sex. Contact their healthcare provider and continue taking one active light pink tablet each day until otherwise directed. 2.4 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 to 4 hours after tablet-taking, this can be regarded as a missed tablet.

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1 INDICATIONS AND USAGE Nikki (drospirenone and ethinyl estradiol tablets USP) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy.