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Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications.

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table I: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First year. United states.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Method
(1)
Typical Use

Perfect Use2
(3)
(4)
Adapted from Hatcher et al, 1998, Ref. # 1.
1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
ChanceThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.8585
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640
Periodic abstinence2563
  Calendar9
  Ovulation Method3
  Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2
  Post-Ovulation1
Withdrawal194
Cap 1
  Parous Women402642
  Nulliparous Women20956
Sponge
  Parous Women402042
  Nulliparous Women20956
Diaphragm20656
CondomWithout spermicides.
  Female (Reality)21556
  Male14361
Pill571
  Progestin Only0.5
  Combined0.1
IUD
  Progesterone T2.01.581
  Copper T380A0.80.678
  LNg 200.10.181
Depo-Provera0.30.370
Norplant and Norplant-20.050.0588
Female Sterilization0.50.5100
Male Sterilization0.150.10100

1 With spermicidal cream or jelly.

In clinical trials with ORTHO-CYCLEN, 1,651 subjects completed 24,272 cycles and a total of 18 pregnancies were reported. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 0.96 per 100 women-years. This rate includes patients who did not take the drug correctly.

In four clinical trials with ORTHO TRI-CYCLEN, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on ORTHO TRI-CYCLEN, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years.

In two double-blind, placebo-controlled, six month, multicenter clinical trials, ORTHO TRI-CYCLEN showed a statistically significant decrease in inflammatory lesion count and total lesion count (Table II). The adverse reaction profile of ORTHO TRI-CYCLEN from these two controlled clinical trials is consistent with what has been noted from previous studies involving ORTHO TRI-CYCLEN and are the known risks associated with oral contraceptives.

Table II Acne Vulgaris Indication Combined Results: Two Multicenter, Placebo-Controlled Trials Primary Efficacy Variables: Evaluable-for-Efficacy Population
ORTHO TRI-CYCLEN®Placebo
N = 163N = 161
Mean Age at Enrollment27.3 years28.0
Inflammatory Lesions56.636.6
Mean Percent Reduction
Total Lesions49.630.3
Mean Percent Reduction

DOSAGE AND ADMINISTRATION

Oral Contraception

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.

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. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers.") The possibility of ovulation and conception prior to initiation of medication should be considered.

(See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. 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 and a non-hormonal method should be used 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® 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 also available as Refills (NDC 0062-1903-23)

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

ORTHO-CYCLEN 28 Tablets are also available as Refills (NDC 0062-1901-23)

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

Rx only

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