at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.
ORTHO-CYCLEN:
If the patient will start pill-taking on "Day 1," choose a blue pill that corresponds with the day of the week the patient will take the first pill. Remove that blue pill by pressing the pill through the hole in the bottom of the dispenser.
ORTHO TRI-CYCLEN:
If the patient will start pill-taking on a day other than Sunday, a calendar label has been provided and should be placed over the calendar in the center of the VERIDATE. To place the label correctly, identify the correct starting day, locate that day printed in blue on the label, and line that day up with the first white pill directly under the V notch at the top of the dispenser. Remove the label from the backing. Press the center of the label down onto the center of the printed calendar. Remove that white pill by pressing the pill through the hole in the bottom of the dispenser.
After all the dark green pills have been taken, insert a new refill into the VERIDATE. The patient should take the first pill on the next day, even if the patient's period is not over yet.
To Insert New Refill (ORTHO-CYCLEN or ORTHO TRI-CYCLEN):
Lift the empty refill out of the VERIDATE Tablet Dispenser.
Insert the new refill so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under the nibs.
2.3 Missed TabletsTable 2: Instructions for Missed ORTHO-CYCLEN or ORTHO TRI-CYCLEN 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.
2.4 Advice in Case of Gastrointestinal DisturbancesIn 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].
2.5 ORTHO-TRICYCLEN Use for AcneThe timing of initiation of dosing with ORTHO TRI-CYCLEN for acne should follow the guidelines for use of ORTHO TRI-CYCLEN as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.
3 DOSAGE FORMS AND STRENGTHS
ORTHO-CYCLEN:
ORTHO-CYCLEN Tablets are available in blister cards. Each blister card contains 28 tablets in the following order:
21 blue, round, biconvex, coated tablet imprinted "O 250" on one side and "35" on the other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
7 dark green round, biconvex, coat