Tri-Linyah

TRI-LINYAH- norgestimate and ethinyl estradiol
Northstar Rx LLC

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-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].

1.2 Acne

Tri-Linyah 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-Linyah 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-Linyah

Tri-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling (16)]. Tri-Linyah may be started using either a Day 1 start or a Sunday start (see Table 1). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are available. 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-Linyah

Table 1: Instructions for Administration of Tri-Linyah

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-Linyah active tablets are green (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21).
  • Tri-Linyah 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-Linyah.
  • 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-Linyah 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-Linyah Start Tri-Linyah:
  • 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-Linyah after Abortion or Miscarriage

First-trimester

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

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-Linyah, 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-Linyah. [see Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Tri-Linyah after Childbirth

Compact Blister 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 at the top of the dispenser (Sunday) by pressing the pill through the blister foil.If the patient will start pill-taking on “Day 1,” place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill. Remove the first active pill at the top of the dispenser (Day 1) by pressing the pill through the blister foil.

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