Tri-Sprintec

TRI-SPRINTEC- norgestimate and ethinyl estradiol
REMEDYREPACK INC.

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-Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14)] .

1.2 Acne

Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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 Recommended Dosage and Administration

Take one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets).

Table 1: Instructions for Administration of Tri-Sprintec®

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-Sprintec ® active tablets are gray (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21).
  • Tri-Sprintec ® 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-Sprintec ®.
  • 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-Sprintec ® 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-Sprintec ®

Start Tri-Sprintec ®:

  • 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-Sprintec ® after Abortion or Miscarriage

First-trimester

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

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-Sprintec ® , 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-Sprintec ® [see Contraindications ( 4) and Warnings and Precautions ( 5.1)].

Starting Tri-Sprintec ® after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Sprintec ® following the instructions in Table 1 for women not currently using hormonal contraception.
  • Tri-Sprintec ® is not recommended for use in lactating women [see Use in Specific Populations ( 8.2)] .
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-Sprintec ® [see Contraindications ( 4), Warnings and Precautions ( 5.1), and Use in Specific Populations ( 8.1, and 8.2)].

2.2 Recommendations Regarding Missed Doses

Contraceptive failure may occur when active tablets are missed. Table 2 describes instructions for Tri-Sprintec ® dosing and use of additional non-hormonal contraception (such as condoms) when active tablets are missed.

Table 2: Instructions for Missed Tri-Sprintec® 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.


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