Tri-Vylibra Lo Dosage

How to Start Tri-VyLibra Lo (Norgestimate and Ethinyl Estradiol Tablets)

Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is dispensed in a blister pack [see How Supplied/Storage and Handling (16)]. Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) 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-VyLibra Lo (Norgestimate and Ethinyl Estradiol Tablets)

Table 1: Instructions for Administration of Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets)
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-VyLibra Lo (norgestimate and ethinyl estradiol tablets) active tablets are white to off white (Day 1 to Day 7), pale blue to bluish white (Day 8 to Day 14) and blue to light blue (Day 15 to Day 21). Tri-VyLibra Lo inactive tablets are green (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 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets). 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets) 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets)	Start Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets):
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-VyLibra Lo (norgestimate and ethinyl estradiol tablets) after Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) may be started immediately. An additional method of contraception is not needed if Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is started immediately.
• If Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets).

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-VyLibra Lo (norgestimate and ethinyl estradiol tablets), 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets). [see Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) following the instructions in Table 1 for women not currently using hormonal contraception.
• Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) 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-VyLibra Lo (norgestimate and ethinyl estradiol tablets). [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

Blister Pack:

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. The 28-pill pack has 21 white to off white, pale blue to bluish white, and blue to light blue “active” pills (with hormones) to take for 3 weeks. This is followed by 1 week of green “reminder” pills (without hormones).

3. Also find:

1) where on the pack to start taking pills,

2) in what order to take the pills, and

3) the week numbers as shown in the picture below.

4. Be sure you have ready at all times:

Another kind of birth control (such as condoms or spermicide) to use as a back-up method in case you miss pills.

An extra, full pill pack.

You have a choice of which day to start taking your first pack of pills. Tri-VyLibra Lo is available in a blister pack which is preset for a Sunday Start. Day 1 Start stickers are also provided. Decide with your healthcare professional which is the best day for you. Pick a time of day that will be easy to remember.

Sunday Start:

Take the first white to off white “active” pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.

Use another method of birth control (such as condoms or spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

Day 1 Start:

Take the first white to off white "active" pill of the first pack during the first 24 hours of your period.

1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
2. Place this day label strip in the cycle tablet over the area that has the days of the week (starting with Sunday) imprinted in the plastic.

Note: If the first day of your period is a Sunday, you can skip steps #1 and #2.

You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

Missed Tablets

Table 2: Instructions for Missed Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets)
If one active tablet is missed in Weeks 1, 2, or 3	Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
If two active tablets are missed in Week 1 or Week 2	Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3	Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing 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].