Norgestimate and Ethinyl Estradiol

NORGESTIMATE AND ETHINYL ESTRADIOL-
AvKARE

1 INDICATIONS AND USAGE

1.1 Oral Contraception

Norgestimate and Ethinyl Estradiol Tablets, USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Norgestimate and Ethinyl Estradiol Tablets, USP

Norgestimate and Ethinyl Estradiol Tablets, USP is dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING (16)]. Norgestimate and Ethinyl Estradiol Tablets, USP 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, USP

1. Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets, USP

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. Tablet Color: Norgestimate and Ethinyl Estradiol Tablets, USP active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21). Norgestimate and Ethinyl Estradiol Tablets, USP inactive tablets are green (Day 22 to Day 28).	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 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)
	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, USP. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one 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, USP 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, USP	Start Norgestimate and Ethinyl Estradiol Tablets, USP:
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, USP after Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Norgestimate and Ethinyl Estradiol Tablets, USP may be started immediately. An additional method of contraception is not needed if Norgestimate and Ethinyl Estradiol Tablets, USP is started immediately.
• If Norgestimate and Ethinyl Estradiol Tablets, USP is 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, USP.

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, USP, 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, USP. [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and FDA-APPROVED PATIENT LABELING.]

Starting Norgestimate and Ethinyl Estradiol Tablets, USP 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, USP following the instructions in Table 1 for women not currently using hormonal contraception.
• Norgestimate and Ethinyl Estradiol Tablets, USP is 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, USP. [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), USE IN SPECIFIC POPULATIONS (8.1 and 8.3), and FDA-Approved Patient Labeling].

BEFORE YOU START TAKING YOUR PILLS

1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.
2. The 28-pill pack has 21 white, light blue, and blue “active” pills (with hormones) to take for 3 weeks. This is followed by 1 week of green “reminder” pills (without hormones).
3. ALSO FIND:
4. where on the pack to start taking pills,
5. in what order to take the pills (follow the arrows),
6. The week numbers as shown in the diagram below.

1. BE SURE YOU HAVE READY AT ALL TIMES:
   ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up method in case you miss pills. AN EXTRA, FULL PILL PACK.

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