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Ortho-Novum

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Ortho-Novum

Ortho-Novum

INDICATIONS

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7, ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35, and MODICON Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

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, 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 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 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  
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
Withdrawal 19 4  
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
Adapted from Hatcher et al, 1998 Ref. #1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal 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.
3Among 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.
5Foams, 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.
7With spermicidal cream or jelly.
8Without 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 Food and Drug Administration has declared the following brands of oral contra-ceptives 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 2 light-orange pills), Lo/Ovral®(1 dose is 4 white pills), Triphasil®or Tri-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 six months of age.

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7,ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35 and MODICON have not been studied for and are not indicated for use in emergency contraception.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, ORTHO-NOVUM (norethindrone and ethinyl estradiol) Tablets and MODICON Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. ORTHO-NOVUM (norethindrone and ethinyl estradiol) Tablets and MODICON Tablets are available in the DIALPAK®Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also available.

Sunday Start

When taking ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7, ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35, and MODICON, the first “active” tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first “active” tablet should be taken that day. Take one “active” tablet daily for 21 days followed by one 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) “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 Week1 or Week2, 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 such as condoms or spermicide 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 con-tinue 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-NOVUM (norethindrone and ethinyl estradiol) 7/7/7, ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35, and MODICON, for the initial cycle of therapy is one “active” tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as “Day 1” followed by one 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) “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 Week1 or Week2, 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 such as condoms or spermicide 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-NOVUM (norethindrone and ethinyl estradiol) 7/7/7, ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35, and MODICONfor 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

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 if pregnancy is confirmed.
  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

HOW SUPPLIED

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1781-15) containing 28 tablets, as follows: 7 white, round, flat-faced beveled edged tablets imprinted with “Ortho 535” on both sides (0.5 mg norethindrone and 0.035 mg ethinyl estradiol), 7 light peach, round, flat-faced, beveled edged tablets imprinted with “Ortho 75” on both sides (0.75 mg norethindrone and 0.035 mg ethinyl estradiol), 7 peach, round, flat-faced, beveled edged tablets imprinted with “Ortho 135” on both sides (1 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 green, round, flat-faced, beveled edged tablets imprinted “Ortho” on both sides containing inert ingredients.

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7 is available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1781-20).

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1761-15) containing 28 tablets, as follows: 21 peach, round, flat-faced, beveled edged tablets imprinted “Ortho 135” on both sides (1 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 green, round, flat-faced, beveled edged tablets imprinted “Ortho” on both sides containing inert ingredients.

ORTHO-NOVUM (norethindrone and ethinyl estradiol) 1/35 is available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1761-20).

MODICON Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1714-15) containing 28 tablets, as follows: 21 white, round, flat-faced, beveled edged tablets imprinted “Ortho 535” on both sides (0.5 mg norethin-drone and 0.035 mg ethinyl estradiol) and 7 green, round, flat-faced, beveled edged tablets imprinted “Ortho” on both sides containing inert ingredients.

MODICON is available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1714-20).

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

REFERENCES

1. Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.

79. Schlesselman J, Stadel BV, Murray P, Lai S. Breast cancer in relation to early use of oral contraceptives. JAMA 1988; 259:1828-1833.

80. Hennekens CH, Speizer FE, Lipnick RJ, Rosner B, Bain C, Belanger C, Stampfer MJ, Willett W, Peto R. A case-control study of oral contraceptive use and breast cancer. JNCI 1984; 72:39-42.

81. LaVecchia C, Decarli A, Fasoli M, Franceschi S, Gentile A, Negri E, Parazzini F, Tognoni G. Oral contraceptives and cancers of the breast and of the female genital tract. Interim results from a case-control study. Br J Cancer 1986; 54:311-317.

82. Meirik O, Lund E, Adami H, Bergstrom R, Christoffersen T, Bergsjo P. Oral contraceptive use and breast cancer in young women. A Joint National Case-control study in Sweden and Norway. Lancet 1986; 11:650-654.

83. Kay CR, Hannaford PC. Breast cancer and the pill - A further report from the Royal College of General Practitioners' oral contraception study. Br J Cancer 1988; 58:675-680.

84. Stadel BV, Lai S, Schlesselman JJ, Murray P. Oral contraceptives and premenopausal breast cancer in nul-liparous women. Contraception 1988; 38:287-299.

85. Miller DR, Rosenberg L, Kaufman DW, Stolley P, Warshauer ME, Shapiro S. Breast cancer before age 45 and oral contraceptive use: New Findings. Am J Epidemiol 1989; 129:269-280.

86. The UK National Case-Control Study Group, Oral contraceptive use and breast cancer risk in young women. Lancet 1989; 1:973-982.

87. Schlesselman JJ. Cancer of the breast and reproductive tract in relation to use of oral contraceptives. Contraception 1989; 40:1-38.

88. Vessey MP, McPherson K, Villard-Mackintosh L, Yeates D. Oral contraceptives and breast cancer: latest findings in a large cohort study. Br J Cancer 1989; 59:613-617.

89. Jick SS, Walker AM, Stergachis A, Jick H. Oral contraceptives and breast cancer. Br J Cancer 1989; 59:618-621.

90. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347:1713-1727.

91. Palmer JR, Rosenberg L, Kaufman DW, Warshauer ME, Stolley P, Shapiro S. Oral Contraceptive Use and Liver Cancer. Am J Epidemiol 1989; 130:878-882.

ORTHO-McNEIL PHARMACEUTICAL, INC. Raritan, New Jersey 08869. Revised October 2006 FDA revision date: 2/21/2002

Last reviewed on RxList: 12/28/2007
This monograph has been modified to include the generic and brand name in many instances.

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