Lutera

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Lutera ® (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lutera is one orange tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Lutera tablets be taken at the same time each day. During The First Cycle Of Use The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking Lutera on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start). Sunday start: The patient is instructed to begin taking Lutera on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (orange) is taken that day. One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Lutera until an orange tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days. Day 1 start: During the first cycle of medication, the patient is instructed to begin taking Lutera during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Lutera tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Lutera tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days. After the first cycle of use The patient begins her next and all subsequent courses of tablets on the day after taking her last white tablet. She should follow the same dosing schedule: 21 days on orange tablets followed by 7 days on white tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken an orange tablet daily for 7 consecutive days. Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Lutera. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Lutera on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Lutera the next day. If switching from an implant or injection, the patient should start Lutera on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, implant, or intrauterine system (IUS), the patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days of the first pack. If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Risk of pregnancy if tablets are missed While there is little likelihood of ovulation occurring if only one or two orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled orange tablets are missed. Although the occurrence of pregnancy is unlikely if Lutera is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. The risk of pregnancy increases with each active (orange) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below. Use after pregnancy, abortion or miscarriage Lutera may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use aadditional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days. Lutera may be initiated immediately after a first trimester abortion or miscarriage. Instruct the patient to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days, unless starting Lutera on the day of surgical abortion.

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INDICATIONS AND USAGE Lutera is indicated for use by females of reproductive potential to prevent pregnancy.