Tri-Sprintec

TRI-SPRINTEC- norgestimate and ethinyl estradiol
Barr Laboratories Inc.

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

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].

1.2 Acne

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is 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. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) 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 Tri-Sprintec

Tri-Sprintec is dispensed in a blister pack tablet dispenser [see How Supplied/Storage and Handling (16)]. Tri-Sprintec 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 Tri-Sprintec

Table 1: Instructions for Administration of Tri-Sprintec

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:

Tri-Sprintec active tablets are gray (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21).
Tri-Sprintec has white 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 white 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 Tri-Sprintec.
Take subsequent active tablets once daily at the same time each day for a total of 21 days.
Take one white 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 Tri-Sprintec 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 Tri-Sprintec

Start Tri-Sprintec:

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 Tri-Sprintec after Abortion or Miscarriage

First-trimester

After a first-trimester abortion or miscarriage, Tri-Sprintec may be started immediately. An additional method of contraception is not needed if Tri-Sprintec is started immediately.
If Tri-Sprintec 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 Tri-Sprintec.

Second-trimester

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri-Sprintec, 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 Tri-Sprintec. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Tri-Sprintec after Childbirth

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Sprintec following the instructions in Table 1 for women not currently using hormonal contraception.
Tri-Sprintec 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 Tri-Sprintec. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

How to Use the Blister Cards

There are two ways to start taking birth control pills, Sunday Start or Day 1 Start. Your healthcare professional will tell you which to use.

1.
Pick the Days of the Week Sticker that starts the first day of your period. (This is the day you begin bleeding or spotting, even if it is midnight when bleeding begins.) When you have picked the right sticker, throw away the others and place the sticker on the blister card over the pre-printed days of the week and make sure it lines up with the pills.
2.
Your blister package consists of three parts, the foil pouch, wallet, and a blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. There are 7 gray “active” pills, 7 light blue “active” pills, 7 blue “active” pills, and 7 white “reminder” pills. Refer to the sample of the blister card below:
Blister
3.
After taking the last white pill, start a new blister card the very next day no matter when your period started. You will be taking a pill every day without interruption. Anytime you start the pills later than directed, protect yourself by using another method of birth control until you have taken a pill a day for seven consecutive days. After taking the last white pill, start taking the first gray pill from the blister card the very next day.
4.
Take the pills in each new package as before. Start with the gray pill on row #1 and take one pill each day, left to right, until the last white pill has been taken.

Three Ways to Remember in What Order to take the Pills

1.
Follow the sticker with the days of the week (placed above the pills).
2.
Always go from left to right.
3.
Always finish all your pills.

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