EN 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 ORTHO-CYCLEN or ORTHO TRI-CYCLENORTHO-CYCLEN and ORTHO TRI-CYCLEN are dispensed in either a DIALPAK Tablet dispenser or a VERIDATE Tablet Dispenser [see How Supplied/Storage and Handling (16)]. ORTHO-CYCLEN and ORTHO TRI-CYCLEN 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 ORTHO-CYCLEN or ORTHO TRI-CYCLENTable 1: Instructions for Administration of ORTHO-CYCLEN or ORTHO TRI-CYCLEN Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.
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:
ORTHO-CYCLEN active tablets are blue (Day 1 to Day 21).
ORTHO TRI-CYCLEN active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21).
ORTHO-CYCLEN and ORTHO TRI-CYCLEN both have dark 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 dark 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 ORTHO-CYCLEN or ORTHO TRI-CYCLEN.
Take subsequent active tablets once daily at the same time each day for a total of 21 days.
Take one dark 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 ORTHO-CYCLEN or ORTHO TRI-CYCLEN 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 ORTHO-CYCLEN or ORTHO TRI-CYCLEN Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN:
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
