Prescription Drug Information: Previfem

PREVIFEM- norgestimate and ethinyl estradiol
Central Texas Community Health Centers

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

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].

1.2 Acne

Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) 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. Previfem® (norgestimate/ethinyl estradiol tablets USP) 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 Previfem® (norgestimate/ethinyl estradiol tablets) or Tri-Previfem® (norgestimate/ethinyl estradiol tablets)

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) are dispensed in a blister pack tablet dispenser [see How Supplied/Storage and Handling (16)].

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) 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 Previfem® or Tri-Previfem®

Table 1: Instructions for Administration of Previfem® or Tri-Previfem®

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:

  • Previfem® active tablets are blue (Day 1 to Day 21).
  • Tri-Previfem® active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21).
  • Previfem® and Tri-Previfem® both have light-green 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 light-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 Previfem® or Tri-Previfem®.
  • Take subsequent active tablets once daily at the same time each day for a total of 21 days.
  • Take one light-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 Previfem® or Tri-Previfem® from another oral contraceptiveStart on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Previfem® or Tri-Previfem® Start Previfem® or Tri-Previfem® :
  • 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 Previfem® and Tri-Previfem® after Abortion or Miscarriage

First-trimester

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

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Previfem® or Tri-Previfem® , 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 Previfem® or Tri-Previfem® [see Contraindications(4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling].

Starting Previfem® or Tri-Previfem® after Childbirth

Previfem ® and Tri-Previfem ® come in a blister pack pill dispenser. Read the instructions below for using the blister pack pill dispenser.

The blister package consists of three parts, the calendar label, the sleeve and the blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. Refer to the sample of the blister pack below:

Blister card guide
(click image for full-size original)

Previfem® consists of 21 blue “active” birth control pills and 7 light green “reminder” pills.

Tri-Previfem® consists of 7 white “active” pills, 7 light-blue “active” pills, 7 blue “active” pills and 7 light green “reminder” pills.

There are two ways to start taking birth-control pills, Sunday Start or Day 1 Start.

How to use Blister Cards for the 28 tablets 1. If Sunday Start, the patient discards the stickers and takes the first active pill on the first Sunday after their menstrual period begins. 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 Previfem® or Tri-Previfem®.

2. If Day 1 Start, the patient picks the Days of the Week Sticker that starts the first day of their period. When the patient has picked the right sticker, they need to throw away the others and place the sticker on the blister card over the preprinted days of the week and make sure it lines up with the pills.

3. The patient removes the first pill by pushing down on the pill and waits 24 hours to take their next pill. The patient continues to take one pill each day until all the pills have been taken.

4. The pill should be taken at the same time each day.

5. After taking the last pill, the patient starts a new blister pack the very next day, no matter when their next period starts.

6. The patient should take the pills in each new package as before and start with the pill on the first row and take one pill each day, left to right, until the last pill has been taken.

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