INDICATIONS
Indications
Ethinyl estradiol, levonorgestrel is indicated for the
prevention of pregnancy in women after known or suspected
contraceptive failure or unprotected intercourse. To obtain
optimal efficacy, use of these pills should begin as soon
as possible but within 72 hours of intercourse.
Efficacy
If one hundred women used ECPs correctly in one month,
about two women would become pregnant after a single act
of intercourse. If no contraception is used about eight
women would become pregnant after a single act of intercourse.
Therefore, the use of ECPs results in a 75% reduction
in the number of pregnancies to be expected if no ECPs
were used after unprotected intercourse. Notably, some
clinical trials have shown that efficacy was greatest
when ECPs were taken within 24 hours of unprotected intercourse,
decreasing somewhat during each subsequent 24-hour period.
ECPs are not as effective as some other forms of contraception.
For effectiveness rates of other contraceptive methods,
refer to TABLE 2.
| TABLE 2
Percentage of Women Experiencing an Unintended Pregnancy
During the First Year of Typical Use and the First
Year of Contraception and the Percentage Continuing
Use at the End of the First Year¾United
States. |
| |
% of Women Experiencing an Unintended Pregnancy within
the First Year of Use
|
% of Women Continuing Use at 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 |
|
| Symptom-thermal¤ |
|
2 |
|
| Post-ovulation |
|
1 |
|
| Withdrawal |
19 |
4 |
|
|
|
| Parous Women |
40 |
26 |
42 |
| Nulliparous Women |
20 |
9 |
56 |
|
|
| Parous women |
40 |
20 |
42 |
| Nulliparous women |
20 |
9 |
56 |
| Diaphragm¶ |
20 |
6 |
56 |
|
|
| Female (Reality) |
21 |
5 |
56 |
| Male |
14 |
3 |
56 |
| Oral Contraceptives |
5 |
|
71 |
| Progestin Only |
|
0.5 |
|
| Combined |
|
0.1 |
|
|
|
| Progestin T |
2.0 |
1.5 |
81 |
| Copper T 380A |
0.8 |
0.6 |
78 |
| LNG |
0.1 |
0.1 |
81 |
| Depo-Provera |
0.3 |
0.3 |
|
| 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 the risk of pregnancy
by at least 75% |
| Lactational Amenorrhea
Method: LAM is a highly effective temporary method
of contraception†† |
| * Among
typical couples who initiate use of a method (not
necessarily for the first time) 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
percent 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 among
women now relying on reversible methods of contraception
if they abandoned contraception altogether. |
| §
Foams, creams, gels, vaginal suppositories, and
vaginal film. |
| ¤
Cervical mucus (ovulation) method supplemented by
calendar in the pre-ovulatory and basal body temperature
in the post-ovulatory phases. |
| ¶
With spermicidal cream or jelly. |
| ** Without
spermicides. |
| †† However,
to maintain an 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, Guest F, Kowal
D. Contraceptive Technology Seventeenth Revised
Edition. New York NY: Irvington Publishers, 1998 |
DOSAGE AND ADMINISTRATION
The Preven Emergency Contraceptive Kit contains a pregnancy
test. This test can be used to verify an existing pregnancy
resulting from intercourse that occurred earlier in the
current menstrual cycle or the previous cycle. If a positive
pregnancy result is obtained, the patient should not take
the pills in the Preven Kit.
The initial two pills must be taken as soon as possible
but within 72 hours of unprotected intercourse. This is
followed by the second dose of two pills 12 hours later.
The patient should be instructed that if she vomits within
one hour of taking either dose of the medication, she
should contact her healthcare professional to discuss
whether to repeat that dose or to take an antinausea medication.
ECPs are not indicated for ongoing pregnancy protection
and should not be used as a woman's routine form of contraception.
HOW SUPPLIED
The Preven Emergency Contraceptive Kit is available in
a carton which includes a patient information book, a
pregnancy test in a sealed foil pack, four emergency contraceptive
pills (ECPs) and detailed patient labeling.
Each pill contains 0.25 mg levonorgestrel and 0.05 mg
ethinyl estradiol. The pills are marked with a G on one
side and the numerals 891 on the other.
Storage: Store at 25°C (77°F); excursions permitted
to 15-30°C (59-86°F).
|
