TRI-ESTARYLLA- norgestimate and ethinyl estradiol
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)].
Tri-Estarylla™ (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].
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)].
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.
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.
Day 1 Start:
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Start on the same day that a new pack of the previous oral contraceptive would have started.
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Start Tri- Estarylla ™:
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Starting Tri- Estarylla ™ after Abortion or Miscarriage
- 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™.
- 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
- DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.
- 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).
- where on the pack to start taking pills,
- in what order to take the pills (follow the arrows)
- 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.
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