INDICATIONS AND USAGE
Pirmella 1/35 is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental 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.
Source: Trussel J, Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
1Among 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.
2Among 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.
3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4The 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.
5Foams, creams, gels, vaginal suppositories, and vaginal film.
6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7With spermicidal cream or jelly.
8Without spermicides.
9The 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).
1
0However, 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.
Table
I
:
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
Year3
Method
(
1
)
Typical
Use1
(
2
)
Perfect
Use2
(
3
)
(
4
)
Chance4
85
85
Spermicides5
26
6
40
Periodicabstinence
25
63
Calendar
9
OvulationMethod
3
Sympto-Thermal6
2
Post-Ovulation
1
Cap7
ParousWomen
40
26
42
NulliparousWomen
20
9
56
Sponge
ParousWomen
40
20
42
NulliparousWomen
20
9
56
Diaphragm7
20
6
56
Withdrawal
19
4
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
Depo-Provera
0.3
0.3
70
NorplantandNorplant-2
0.05
0.05
88
FemaleSterilization
0.5
0.5
100
MaleSterilization
0.15
0.10
100
AdaptedfromHatcheretal,1998,Ref.#1.EmergencyContraceptivePills:Treatmentinitiatedwithin72hoursafterunprotectedintercoursereducestheriskofpregnancybyatleast75%.9
LactationalAmenorrheaMethod:LAMisahighlyeffective,temporarymethodofcontraception.1
0
Pirmella 1/35 has not been studied for and is not indicated for use in emergency contraception.