Norgestimate and Ethinyl Estradiol

NORGESTIMATE AND ETHINYL ESTRADIOL-
A-S Medication Solutions

WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4)].

1 INDICATIONS AND USAGE

1.1 Oral Contraceptive

Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].

1.2 Acne

Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

Norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, and norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg are dispensed in blister packs [see How Supplied/Storage and Handling (16)]. Norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, and norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

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, 0.25 mg/0.035 mg active tablets are blue (Day 1 to Day 21).
Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg active tablets are white to off-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, 0.25 mg/0.035 mg, and Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg both have light green inactive tablets (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 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)

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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg
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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

Start Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg:

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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg after Abortion or Miscarriage

First-trimester

After a first-trimester abortion or miscarriage, Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg may be started immediately. An additional method of contraception is not needed if Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are started immediately.
If Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.

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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg following the instructions in Table 1 for women not currently using hormonal contraception.
Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

Blister Card Tablet Dispenser

If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient’s menstrual period begins. Remove the first active pill in the top row of the blister card (Sunday) by pressing the pill through the foil in the bottom of the blister card.

Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg

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Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

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Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg:

If the patient will start pill-taking on a day other than Sunday, a day label strip has been provided and should be placed over the calendar at the top of the blister card.
To place the label correctly, pick the day label strip that starts with the first day of the patient’s period (this is the day the patient starts bleeding or spotting, even if it is almost midnight when the bleeding begins). Place this day label strip on the tablet blister card over the area that has the days of the week (starting with Sunday) imprinted in the plastic. Remove the first blue pill by pressing the pill through the foil in the bottom of the blister card.

Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

If the patient will start pill-taking on a day other than Sunday, a day label strip has been provided and should be placed over the calendar at the top of the blister card.
To place the label correctly, pick the day label strip that starts with the first day of the patient’s period (this is the day the patient starts bleeding or spotting, even if it is almost midnight when the bleeding begins). Place this day label strip on the tablet blister card over the area that has the days of the week (starting with Sunday) imprinted in the plastic. Remove the first white to off-white pill by pressing the pill through the foil in the bottom of the blister card.
After all the light green pills have been taken, start a new blister pack. The patient should take the first pill on the next day, even if the patient’s period is not over yet.

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