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Ortho-Tri-Cyclen Lo

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Ortho-Tri-Cyclen Lo

Indications
Dosage
How Supplied

INDICATIONS

ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN® Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN® Lo users99. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, the IUD, and the Norplant® system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table 2: 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 Year3
Method
(1)
Typical Use1
(2)
Perfect Use2
(3)

(4)
Chance4 85 85  
Spermicides5 26 6 40
Periodic abstinence 25   63
  Calendar   9  
  Ovulation Method   3  
  Sympto-Thermal6   2  
  Post-Ovulation   1  
Withdrawal 19 4  
Cap7      
  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge      
  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragm7 20 6 56
Condom8      
  Female (Reality®) 21 5 56
  Male 14 3 61
Pill 5   71
  Progestin Only   0.5  
  Combined   0.1  
IUD      
  Progesterone T 2.0 1.5 81
  Copper T380A 0.8 0.6 78
  LNg 20 0.1 0.1 81
Depo-Provera® 0.3 0.3 70
Norplant® and Norplant-2® 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D,
Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
1
 Among 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.
2
 Among 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.
3
 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4
 The 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.
5
 Foams, creams, gels, vaginal suppositories, and vaginal film.
6
 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7
 With spermicidal cream or jelly.
Without spermicides.
9
 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills).
10
However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

ORTHO TRI-CYCLEN® Lo has not been studied for and is not indicated for use in emergency contraception.

DOSAGE AND ADMINISTRATION

Oral Contraception

To achieve maximum contraceptive effectiveness, ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. ORTHO TRI-CYCLEN® Lo is available in the DIALPAK® Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.

Sunday Start

When taking ORTHO TRI-CYCLEN® Lo the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the menstrual period begins on Sunday, the first white "active" tablet should be taken that day. Take one white, light blue or dark blue "active" tablet daily for 21 days followed by one dark green "reminder" 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) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" 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) dark blue "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).

Day 1 Start

The dosage of ORTHO TRI-CYCLEN® Lo for the initial cycle of therapy is one white, light blue or dark blue "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 dark green "reminder" 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) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" 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) dark blue "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).

When switching from another oral contraceptive, ORTHO TRI-CYCLEN® Lo should be started on the same day that a new pack of the previous oral contraceptive would have been started.

The use of ORTHO TRI-CYCLEN® Lo for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. 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 if pregnancy is confirmed.
  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.

HOW SUPPLIED

ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol) are available in a DIALPAK® Tablet Dispenser (NDC 0062-1251-15) containing 28 tablets. Each of the 7 white, round, convex, coated tablets imprinted "O-M" on one side and "180" on the other side contains 0.180 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 light blue, round, convex, coated tablets imprinted "O-M" on one side and "215" on the other side contains 0.215 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark blue, round, convex, coated tablets imprinted "O-M" on one side and "250" on the other side contains 0.250 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark green, round, convex, coated tablets imprinted "O-M" on one side and "P" on the other side contains inert ingredients.

ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol) are available for clinic usage in a VERIDATE® Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1251-20).

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).

Protect from light.

REFERENCES:

99. Hampton RM, Short M, Bieber E, et al. Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. Contraception 2001;63:289-295.

ORTHO-McNEIL PHARMACEUTICAL, INC. Raritan, New Jersey 08869
Revised: November 2004
FDA rev date: 1/3/2003

Last reviewed on RxList: 6/27/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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