Tri-Estarylla

TRI-ESTARYLLA- norgestimate and ethinyl estradiol
Xiromed, LLC.

tri-estartri-estar-carton

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSCigarette 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-Estarylla™ (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].

1.2 Acne

Tri-Estarylla™ 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-Estarylla™ 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-Estarylla™

Tri-Estarylla™ (norgestimate and ethinyl estradiol tablets), is dispensed in a blister pack [see HOW SUPPLIED/STORAGE AND HANDLING (16)]. Tri-Estarylla™ 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-Estarylla™

Table 1: Instructions for Administration of Tri- Estarylla

Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

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-Estarylla™ active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day15 to Day 21).
Tri-Estarylla™ has 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 green inactive tablet daily for 7 days and at the same time of day that active tablets were taken.
Begin each subsequent blister pack on the same day of Tri-Estarylla™ the week as the first cycle blister 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- Estarylla ™.
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 Tri- Estarylla ™ 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- Estarylla

Start Tri- Estarylla ™:

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

Starting Tri- Estarylla after Abortion or Miscarriage

First-trimester

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

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-Estarylla™, 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-Estarylla™. [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), and FDA-Approved Patient Labeling.]

Starting Tri- Estarylla ™ after Childbirth

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Estarylla™ following the instructions in Table 1 (above) for women not currently using hormonal contraception.
Tri-Estarylla™ 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-Estarylla™. [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.
LOOK AT YOUR PILL BLISTER PACK

The pill pack has 21 active pills (with hormones) to take for 3 weeks. This is followed by 1 week of reminder green pills (without hormones).

3.ALSO FIND:

1)
where on the pack to start taking pills,
2)
in what order to take the pills (follow the arrows)
3)
The week numbers as shown in the diagram below
tri-estar
(click image for full-size original)

4.BE SURE YOU HAVE READY AT ALL TIMES:

Another kind of birth control (such as a condom or spermicide) to use as a back-up method in case you miss pills.
An extra, full pill blister pack.

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