Drug Information for WATSON PHARMARevised: June 2005IN-5260/SPHYSICIAN LABELING Brevicon (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg) Norinyl 1+35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) Norinyl 1+50 (Norethindrone and Mestranol Tablets USP, 1 mg/0.05 mg) Rx Only (Watson Pharma, Inc.): INDICATIONS AND USAGE

  • Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

    Oral contraceptive products such as Norinyl 1+50, which contain 50 mcg of estrogen, should not be used unless medically indicated.

    Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 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% of Women
    Pregnancy within the First Year of UseContinuing Use
    at One Year3
    Method Typical Use1Perfect Use2
    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 a highly effective, temporary method of contraception.10
    Source: Trussell J. Contraceptive Efficacy Table from Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, in 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.
    8 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 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), Aleese (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.
    Periodic abstinence2563
    Ovulation method3
    Parous women402642
    Nulliparous women20956
    Parous women402042
    Nulliparous women20956
    Female (Reality)21556
    Progestin only0.5
    Progesterone T2.01.581
    Copper T 380A0.80.678
    LNg 200.10.181
    Norplant and Norplant-20.050.0588
    Female sterilization0.50.5100
    Male sterilization0.150.10100
  • Drug Information Provided by National Library of Medicine (NLM).