Tri Femynor

TRI FEMYNOR- norgestimate and ethinyl estradiol
Amneal Pharmaceuticals NY 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 Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ].

1.2 Acne

Tri Femynor 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 Femynor 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 Femynor

Tri Femynor tablets are dispensed in a blister pack [see How Supplied/Storage and Handling (16) ]. Tri Femynor 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.

2.2 How to Take Tri Femynor

Table 1: Instructions for Administration of Tri Femynor

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 Femynor active tablets are light pink (Day 1 to day 7), light red (Day 8 to Day 15) and red (Day 16 to Day 21).
  • Tri Femynor has white inactive tablets (Day 22 to Day 28).

Day 1 Start:

  • Take first light pink “active” tablet without regard to meals on the first day of menses.
  • Take subsequent light pink, light red or red “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 white “inactive” tablet)

Sunday Start:

  • Take first light pink “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 Femynor.
  • Take subsequent light pink, light red or red “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 white “inactive” tablet) and additional non-hormonal contraceptive is not needed.

Switching to Tri Femynor 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 Femynor

Start Tri Femynor :

  • 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 Femynorafter Abortion or Miscarriage

First-trimester

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

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

Starting Tri Femynorafter Childbirth

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

blister for PI

SET THE DAY:

 Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.

 Sunday Start: Take the first pill of the first blister pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the blister pack that same day.

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