Options For Dosage and Administration

Regimen Options

To achieve maximum contraceptive effectiveness, ORTHO TRI-CYCLEN Tablets and ORTHO-CYCLEN Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. ORTHO TRI-CYCLEN and ORTHO-CYCLEN are available in the DIALPAK Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided. Your doctor will instruct you whether you are a "Day One" starter or a "Sunday" starter.

Ortho Tri-Cyclen Prices and Order Information

21-Day Regimen (Sunday Start)

When taking ORTHO TRI-CYCLEN 21 and ORTHO-CYCLEN 21, the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet is taken on that day. One tablet is taken daily for 21 days. For subsequent cycles, no tablets are taken for 7 days, then a tablet is taken the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill" section).

21-Day Regimen (Day 1 Start)

The dosage of ORTHO TRI-CYCLEN 21 and ORTHO-CYCLEN 21, for the initial cycle of therapy is one tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1." For subsequent cycles, no tablets are taken for 7 days, then a new course is started of one tablet a day for 21 days. The dosage regimen then continues with 7 days of no medication, followed by 21 days of medication, instituting a three-weeks-on, one-week-off dosage regimen.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill" section).

28-Day Regimen (Sunday Start)

When taking ORTHO TRI-CYCLEN 28 and ORTHO-CYCLEN 28 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one green tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (" How to Take the Pill" section).

28-Day Regimen (Day 1 Start)

The dosage of ORTHO TRI-CYCLEN 28 and ORTHO-CYCLEN 28, for the initial cycle of therapy is one active tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one green tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

The use of ORTHO TRI-CYCLEN and ORTHO-CYCLEN for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception prior to initiation of medication should be considered.

ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contra-ceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out.

2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

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 for oral contraceptives. The dosage regimen for ORTHO TRI-CYCLEN for treatment of facial acne, as available in a DIALPAK Tablet Dispenser, utilizes a 21-day active and a 7-day placebo schedule. Take one active tablet daily for 21 days followed by one green tablet for 7 days. After 28 tablets have been taken, a new course is started the next day.

HOW SUPPLIED

ORTHO TRI-CYCLEN 21 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1902-15) containing 21 tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol.

The white tablets are unscored, with "Ortho" and "180" debossed on each side; the light blue tablets are unscored with "Ortho" and "215" debossed on each side; the blue tablets are unscored with "Ortho" and "250" debossed on each side.

ORTHO TRI-CYCLEN 21 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1902-20).

ORTHO TRI-CYCLEN 28 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1903-15) containing 28 tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each green tablet contains inert ingredients.

The white tablets are unscored, with "Ortho" and "180" debossed on each side; the light blue tablets are unscored with "Ortho" and "215" debossed on each side; the blue tablets are unscored with "Ortho" and "250" debossed on each side.

ORTHO TRI-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1903-20).

ORTHO-CYCLEN 21 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1900-15) containing 21 tablets. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are unscored with "Ortho" and "250" debossed on each side.

ORTHO-CYCLEN 21 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1900-20).

ORTHO-CYCLEN 28 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1901-15) containing 28 tablets as follows: 21 blue tablets as described under ORTHO-CYCLEN 21 Tablets, and 7 green tablets containing inert ingredients.

ORTHO-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1901-20).

 

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