INDICATIONS AND USAGE
Pirmella 7/7/7 and Pirmella 1/35 Tablets are 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 1 lists the typical accidental pregnancy rates for users of combined 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.
Table
1
:
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
YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Method
(
1
)
Typical
UseAmong 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.
(
2
)
Perfect
UseAmong 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.
(
3
)
(
4
)
ChanceThe 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.
85
85
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.
26
6
40
Periodicabstinence
25
63
Calendar
9
OvulationMethod
3
Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
2
Post-Ovulation
1
CapWith spermicidal cream or jelly.
ParousWomen
40
26
42
NulliparousWomen
20
9
56
Sponge
ParousWomen
40
20
42
NulliparousWomen
20
9
56
Diaphragm
20
6
56
Withdrawal
19
4
CondomWithout spermicides.
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%.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).
LactationalAmenorrheaMethod:LAMisahighlyeffective,temporarymethodofcontraception.
0
Pirmella 7/7/7 and Pirmella 1/35 have not been studied for and are not indicated for use in emergency contraception.