INDICATIONS AND USAGE
Jolessa tablets 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 18-35
years of age during 809 completed 91-day cycles of Jolessa 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*
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
Withdrawal
19
4
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
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 the risk of pregnancy by
at least 75%.
Lactational Amenorrhea Method: LAM is a highly
effective, temporary method of contraception.
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.
*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 unintended 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 unintended pregnancy during the first year if they do not stop
use for any other reason.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 year. This estimate was lowered slightly
(to 85%) to represent the percentage who would 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.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.