INDICATIONS AND USAGE
Levonorgestrel and Ethinyl Estradiol Tablets USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant Implant 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
Year
3
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 unintended 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 erfectly (both consistently and correctly), the percentage who experience an unintended 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 percentages of women 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 ear. This estimate was lowered slightly (to 85%) to represent the percentage who would ecome 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 rands 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).
1
0 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.
Method(1)
TypicalUse1
(2)
PerfectUse2(3)
(4)
Chance4
85
85
Spermicides5
26
6
40
Periodicabstinence
25
63
Calendar
9
Ovulationmethod
3
Sympto-thermal6
2
Post-ovulation
1
Withdrawal
19
4
Cap7
Parouswomen
40
26
42
Nulliparouswomen
20
9
56
Sponge
Parouswomen
40
20
42
Nulliparouswomen
20
9
56
Diaphragm7
20
6
56
Condom8
Female(Reality)
21
5
56
Male
14
3
61
Pill
5
71
Progestinonly
0.5
Combined
0.1
IUD:
ProgesteroneT
2.0
1.5
81
CopperT380A
0.8
0.6
78
LNg20
0.1
0.1
81
DepoProvera
0.3
0.3
70
NorplantandNorplant-2
0.05
0.05
88
Femalesterilization
0.5
0.5
100
Malesterilization
0.15
0.10
100
Emergency
Contraceptive
Pills
:Treatmentinitiatedwithin72hoursafterunprotectedintercoursereducestheriskofpregnancybyatleast75%.9
Lactational
Amenorrhea
Method
:LAMisahighlyeffective,temporarymethodofcontraception.1
0