INDICATIONS AND USAGE
Loestrin 24 Fe is indicated for the prevention of pregnancy in
women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unplanned
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 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 WomenUnintendedthe First Year
Experiencing anPregnancy withof Use
% of Women Continuing Useat One Year*
Method(1)
Typical Use(2)
Perfect Use(3)
(4)
Chance
85
85
Spermicides
26
6
40
Periodic abstinence
25
63
Calendar
9
Ovulation Method
3
Sympto-thermal#
2
Post-Ovulation
1
Cap
Parous Women
40
26
42
Nulliparous Women
20
9
56
Sponge
Parous Women
40
20
42
Nulliparous Women
20
9
56
Diaphragm
20
6
56
Withdrawal
19
4
Condom
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 T 380A
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
Emergency Contraceptive Pills: Treatment initiated
within 72 hours after unprotected intercourse reduces risk of pregnancy by at
least 75%
Lactational Amenorrhea Method: LAM is a highly
effective, temporary method of contraception Source: Trussell J, Stewart F, 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.* Among couples attempting to avoid pregnancy, the percentage who continue to use
a method for one year
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
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
The percentage of women becoming pregnant noted 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% became pregnant in one year. This estimate was lowered slightly (to
85%) to represent the percentage that would become pregnant within one year
among women now relying on reversible methods of contraception if they abandon
contraception altogether
Foams, creams, gels, vaginal suppositories and vaginalfilm # Cervical mucous (ovulation) method supplemented by calendar in the preovulatory
and basal body temperature in the postovulatory phases
With spermicidal cream or jelly
Without spermicides
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) 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
Clinical Studies In a clinical study, 743 women, 18 to 45 years of age, were
treated with Loestrin 24 Fe for up to six 28-day cycles providing a total of
3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of
treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment
cycles during which no backup contraception was used. The Pearl Index for
Loestrin 24 Fe was 1.82.