2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. ( 2.2 ) • Take tablets in the order directed on the blister pack. ( 2.2 ) • Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Norgestimate and Ethinyl Estradiol Tablets Norgestimate and ethinyl estradiol tablets are dispensed in a carton of 3 pouches; each pouch contains a blister pack of 28 tablets [see How Supplied/Storage and Handling ( 16 )] . Norgestimate and ethinyl estradiol tablets may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Norgestimate and Ethinyl Estradiol Tablets Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Day 1 Start: • Take first active tablet without regard to meals on the first day of menses. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one light green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Tablet Color: • Norgestimate and ethinyl estradiol active tablets are white to off-white (Day 1 to Day 7), light yellow (Day 8 to Day 14) and yellow (Day 15 to Day 21). • Norgestimate and ethinyl estradiol have light green inactive tablets (Day 22 to Day 28). Sunday Start: • Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non- hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of norgestimate and ethinyl estradiol tablets. • Take subsequent active tablets once daily at the same time each day for a total of 21 days. • Take one light green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to norgestimate and ethinyl estradiol tablets from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to norgestimate and ethinyl estradiol tablets Start norgestimate and ethinyl estradiol tablets: • Transdermal patch • On the day when next application would have been scheduled • Vaginal ring • On the day when next insertion would have been scheduled • Injection • On the day when next injection would have been scheduled • Intrauterine contraceptive • On the day of removal • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. • Implant • On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Norgestimate and Ethinyl Estradiol Tablets after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, norgestimate and ethinyl estradiol tablets may be started immediately. An additional method of contraception is not needed if norgestimate and ethinyl estradiol tablets are started immediately. • If norgestimate and ethinyl estradiol tablets are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of norgestimate and ethinyl estradiol tablets. Second-trimester • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start norgestimate and ethinyl estradiol tablets, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of norgestimate and ethinyl estradiol tablets. [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling.] Starting Norgestimate and Ethinyl Estradiol Tablets after Childbirth • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with norgestimate and ethinyl estradiol tablets following the instructions in Table 1 for women not currently using hormonal contraception. • Norgestimate and ethinyl estradiol tablets are not recommended for use in lactating women [see Use in Specific Populations ( 8.3 )] . • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of norgestimate and ethinyl estradiol tablets. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 and 8.3 ), and FDA-Approved Patient Labeling]. Blister pack: SET THE DAY: ▪ Sunday Start: The blister is printed with days starting with SUN (Sunday) after start arrow. ▪ Day 1 Start: Paste day start sticker label on the printed days (if your period starts on Tuesday, paste the sticker label "TUE" on the printed day above pill 1 after start arrow and so on). Pill " 1 " is ready to be taken. Always begin the pill cycle with pill " 1 ," after start arrow, as shown on the blister pack. Remove pill "1" by pushing through the blister. The pill will come out through the blister pack. Wait 24 hours to take the next pill. Continue to take one pill each day until all the pills have been taken. When blister pack is empty start a new blister pack on the day after the blister pack is empty. The first pill in every refill will always be taken on the same day of the week, no matter when the patient's next period starts. 2.3 Missed Tablets Table 2: Instructions for Missed Norgestimate and Ethinyl Estradiol Tablets ▪ If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. ▪ If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal 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 active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start : Throw out the rest of the pack and start a new pack that same day. Sunday start : Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. 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 or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling] . 2.5 Norgestimate and Ethinyl Estradiol Tablets Use for Acne The timing of initiation of dosing with norgestimate and ethinyl estradiol tablets for acne should follow the guidelines for use of norgestimate and ethinyl estradiol tablets as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section ( 2.1 ) for instructions.