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Ovrette (Norgestrel) - Indications and Dosage

 
 



INDICATIONS AND USAGE

  1. Indications
    Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
  2. Efficacy
    Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of 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 correctly. Consistent use of these 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
Year 3
Method
(1)
Typical Use 1
(2)
Perfect Use 2
(3)
(4)
Chance 4 85 85
Spermicides 5 26 6 40
Periodic abstinence 25 63
Calendar 9
Ovulation Method 3
Sympto-Thermal 6 2
Post-Ovulation 1
Cap 7
Parous Women 40 26 42
Nulliparous Women 20 9 56
Sponge
Parous Women 40 20 42
Nulliparous Women 20 9 56
Diaphragm 7 20 6 56
Withdrawal 19 4
Condom 8
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
Levonorgestrel
Implants (Norplant®)
0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 9
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.
8 Without spermicides.
9 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.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, OVRETTE must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.

If one menstrual period is missed and the progestin-only oral contraceptive has not been taken according to directions, or if two consecutive periods are missed, tablet-taking should be discontinued and a nonhormonal back-up method of contraception should be used until the possibility of pregnancy is excluded.

HOW SUPPLIED

OVRETTE® tablets (0.075 mg norgestrel) are available in packages of 6 PILPAK® dispensers with 28 tablets each as follows: NDC 0008-0062-01, yellow, round tablet marked "WYETH" on one side and "62" on reverse side.

STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F).

References available upon request.

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