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.

How to Take Tri-Estarylla?

Table 1: Instructions for Administration of Tri-Estarylla

Starting Tri-Estaryllaafter 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-Estaryllaafter 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

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.

Missed Tablets

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

Tri-Estarylla? Use for Acne

The timing of initiation of dosing with Tri-Estarylla for acne should follow the guidelines for use of Tri-Estarylla as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions