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Ortho-Novum (Norethindrone / Mestranol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 10/11, ORTHO-NOVUM 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 1: 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 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)
Perfect UseAmong 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)
(4)
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%.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 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 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.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.
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.
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
Cap 1
  Parous Women402642
  Nulliparous Women20956
Sponge
  Parous Women402042
  Nulliparous Women20956
Diaphragm20656
Withdrawal194
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-Provera®0.30.370
Norplant® and Norplant-2®0.050.0588
Female Sterilization0.50.5100
Male Sterilization0.150.10100

1 With spermicidal cream or jelly.

ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 10/11, ORTHO-NOVUM 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 Tablets and MODICON Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. ORTHO-NOVUM 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 7/7/7, ORTHO-NOVUM 10/11, ORTHO-NOVUM 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 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 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 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-NOVUM 7/7/7, ORTHO-NOVUM 10/11, ORTHO-NOVUM 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 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 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 7/7/7, ORTHO-NOVUM 10/11, ORTHO-NOVUM 1/35, and MODICON 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

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.

HOW SUPPLIED

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

ORTHO-NOVUM 10/11 Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1771-15) containing 28 tablets, as follows: 10 white, round, flat-faced beveled edged tablets imprinted "Ortho 535" on both sides (0.5 mg norethindrone and 0.035 mg ethinyl estradiol), 11 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 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 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 norethindrone 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).

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