TRI-LINYAH- norgestimate and ethinyl estradiol
Northstar Rx LLC
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)].
Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
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)].
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.
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:
| Day 1 Start: |
| Sunday Start: |
|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:|
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|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
- 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.
- 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
- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Linyah following the instructions in Table 1 for women not currently using hormonal contraception.
- Tri-Linyah 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-Linyah. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].
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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