Levonorgestrel and Ethinyl Estradiol

LEVONORGESTREL AND ETHINYL ESTRADIOL-
Glenmark Pharmaceuticals Inc., USA

1 INDICATIONS AND USAGE

Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets

Levonorgestrel and ethinyl estradiol tablets are dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling (16)]. Levonorgestrel and ethinyl estradiol tablets should be started on a Sunday (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.

Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets

Starting levonorgestrel and ethinyl estradiol tablets in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • Levonorgestrel and ethinyl estradiol active tablets are light blue to blue (Day 1 to Day 84). • Levonorgestrel and ethinyl estradiol inactive tablets are white to off-white (Day 85 to Day 91).	Sunday Start: For each 91-day course, take in the following order: • Take the first light blue to blue tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment. • Take subsequent light blue to blue tablets once daily at the same time each day for a total of 84 days. • Take one white to off-white tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the white to off-white tablets are taken. • Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol without interruption on the same day of the week (Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a light blue to blue tablet once a day for 84 days, and a white to off-white tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue to blue tablet daily for 7 consecutive days.
Switching from another contraceptive method to levonorgestrel and ethinyl estradiol tablets	Start levonorgestrel and ethinyl estradiol tablets:
Another oral contraceptive	On the day when the new pack of the previous COC would have been started
Transdermal patch	On the day when the next application would have been scheduled.
Vaginal ring	On the day when the next insertion would have been scheduled.
Injection	On the day when the next injection would have been scheduled.
Intrauterine contraceptive (IUD)	• On the day of removal. • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course.
Implant	On the day of removal.

Starting Levonorgestrel and Ethinyl Estradiol Tablets after Abortion or Miscarriage

First-trimester

•

After a first-trimester abortion or miscarriage, levonorgestrel and ethinyl estradiol tablets may be started immediately. An additional method of contraception is not needed if levonorgestrel and ethinyl estradiol tablets are started immediately.

•

If levonorgestrel 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 or spermicide) for the first seven days of her first 91-day course of levonorgestrel and ethinyl estradiol tablets.

Second-trimester

•

Do not start levonorgestrel and ethinyl estradiol tablets until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start levonorgestrel and ethinyl estradiol tablets following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first 91-day course of levonorgestrel and ethinyl estradiol tablets [see Contraindications (4), Warnings and Precautions (5.1)].

Starting Levonorgestrel and Ethinyl Estradiol tablets after Childbirth

•

Do not start levonorgestrel and ethinyl estradiol tablets until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets following the instructions in Table 1 for women not currently using hormonal contraception.

•

Levonorgestrel and ethinyl estradiol tablets are not recommended for use in lactating women [see Use in Specific Populations (8.2)].

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.2)].

2.2 Dosing Levonorgestrel and Ethinyl Estradiol Tablets

Instruct patients to take one tablet by mouth at the same time every day. The dosing of levonorgestrel and ethinyl estradiol tablets is one light blue to blue pill containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one white to off-white pill (inactive pills without hormone) for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed, in the order directed on the Tablet Dispenser, and at intervals not exceeding 24 hours. Start taking the first light blue to blue pill from a new Tablet Dispenser the very next day after taking the last white to off-white inactive pill in the Tablet Dispenser. The failure rate may increase when pills are missed or taken incorrectly.