July 7, 2015
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Ortho Tri-Cyclen

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Ortho Tri-Cyclen / Ortho-Cyclen




Indications
Dosage
How Supplied

INDICATIONS

Oral Contraceptive

ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies].

Acne

ORTHO TRI-CYCLEN 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. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies].

DOSAGE AND ADMINISTRATION

How To Start Ortho-Cyclen Or Ortho Tri-Cyclen

ORTHO-CYCLEN and ORTHO TRI-CYCLEN are dispensed in either a DIALPAK Tablet dispenser or a VERIDATE Tablet Dispenser [see HOW SUPPLIED/Storage and Handling]. 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.

How To Take Ortho-Cyclen Or Ortho Tri-Cyclen

Table 1: Instructions for Administration of ORTHO-CYCLEN or ORTHO TRI-CYCLEN

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 the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

Starting ORTHO-CYCLEN or ORTHO TRI-CYCLEN after Abortion or Miscarriage

First-trimester
  • After a first-trimester abortion or miscarriage, ORTHO-CYCLEN or ORTHO TRICYCLEN may be started immediately. An additional method of contraception is not needed if ORTHO-CYCLEN or ORTHO TRI-CYCLEN is started immediately.
  • If ORTHO-CYCLEN or ORTHO TRI-CYCLEN 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 ORTHO-CYCLEN or ORTHO TRI-CYCLEN.
Second-trimester
  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start ORTHO-CYCLEN or ORTHO TRICYCLEN, 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 ORTHO-CYCLEN or ORTHO TRI-CYCLEN. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and FDA-Approved Patient Labeling.]

Starting ORTHO-CYCLEN or ORTHO TRI-CYCLEN after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with ORTHO-CYCLEN or ORTHO TRI-CYCLEN following the instructions in Table 1 for women not currently using hormonal contraception.
  • ORTHO-CYCLEN or ORTHO TRI-CYCLEN are not recommended for use in lactating women [see Use in Specific Populations].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of ORTHO-CYCLEN or ORTHO TRI-CYCLEN. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations, and FDA-Approved Patient Labeling].

DIALPAK® Tablet Dispenser: SET THE DAY:

Day 1 Start: turn the dial on the empty DIALPAK until the arrow points to the first day of the patient's period.

Sunday Start: the arrow on the empty DIALPAK should point to SU (Sunday).

Insert the new refill by lining up the “V” shape on the refill with the “V” shape at the top of the DIALPAK. Snap the refill in place. Pill “1” is ready to be taken. Always begin the pill cycle with pill “1,” as shown on the inner part of the refill ring.

DIALPAK Tablet Dispenser - Illustration

Remove pill “1” by pushing down on the pill. The pill will come out through a hole in the back of the DIALPAK.

The patient should wait 24 hours to take the next pill. To take pill “2,” turn the dial on the DIALPAK in a clockwise direction to the next day. Continue to take one pill each day until all the pills have been taken.

Turn the dial to the pill “1” position to remove the empty refill and insert a new refill. The first pill in every refill will always be taken on the same day of the week, no matter when the patient's next period starts.

Turn the dial to the pill “1” position - Illustration

VERIDATE® Tablet Dispenser

  • Place the refill in the VERIDATE Tablet Dispenser 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 all the nibs (see illustration below).
  • If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.

Placing the refill in the VERIDATE Tablet Dispenser- Illustration

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.

Missed Tablets

Table 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.

Advice In Case Of Gastrointestinal Disturbances

In 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].

ORTHO-TRICYCLEN Use For Acne

The 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.

HOW SUPPLIED

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, coated tablet (non-hormonal placebo) imprinted “O-M” on one side and “P” on the other side contains inert ingredients
ORTHO TRI-CYCLEN

ORTHO TRI-CYCLEN Tablets are available in blister cards. Each blister card contains 28 tablets in the following order:

  • 7 white, round, biconvex, coated tablet imprinted “O 180” on one side and “35” on the other side of the tablet contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
  • 7 light blue, round, biconvex, coated tablet imprinted “O 215” on one side and “35” on the other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
  • 7 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, coated tablet (non-hormonal placebo) imprinted “O-M” on one side and “P” on the other side contains inert ingredients

Storage And Handling

ORTHO-CYCLEN

ORTHO-CYCLEN Tablets are available in a blister card with a DIALPAK Tablet Dispenser (unfilled): (NDC 50458-197-00)

Each blister card (28 tablets) contains 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, coated tablet (non-hormonal placebo) imprinted “O-M” on one side and “P” on the other side contains inert ingredients

ORTHO-CYCLEN Tablets are packaged in a carton (NDC 50458-197-15) containing 6 blister cards and 6 unfilled DIALPAK Tablet Dispensers.

ORTHO-CYCLEN Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-197-20).

ORTHO TRI-CYCLEN

ORTHO TRI-CYCLEN Tablets are available in a blister card with a DIALPAK Tablet Dispenser (unfilled): (NDC 50458-191-00)

Each blister card (28 tablets) contains in the following order:

  • 7 white, round, biconvex, coated tablet imprinted “O 180” on one side and “35” on the other side of the tablet contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
  • 7 light blue, round, biconvex, coated tablet imprinted “O 215” on one side and “35” on the other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
  • 7 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, coated tablet (non-hormonal placebo) imprinted “O-M” on one side and “P” on the other side contains inert ingredients

ORTHO TRI-CYCLEN Tablets are packaged in a carton containing 6 blister cards and 6 unfilled DIALPAK Tablet dispensers: (NDC 50458-191-15)

ORTHO TRI-CYCLEN Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-191-20).

Keep out of reach of children.

Storage Conditions
  • Store at 20-25°C (68-77°F); excursions permitted to 15° to 30°C (59° to 86°F).
  • Protect from light.

Mfd. by: Janssen Ortho, LLC, Manati, Puerto Rico 00674, Mfd. for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560. Revised April 2015

Last reviewed on RxList: 5/15/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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