Brand name:
ALESSE
(levonorgestrel and ethinyl estradiol) Tablets
Patients should be counseled that oral contraceptives do not protect
against transmission of HIV (AIDS) and other sexually transmitted diseases
(STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis
B, and syphilis.
Why is Alesse prescribed?
ALESSE 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 II 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 Norplant® System, depends
upon the reliability with which they are used. Correct and consistent
use of methods can result in lower failure rates.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, ALESSE® (levonorgestrel
and ethinyl estradiol tablets) must be taken exactly as directed and
at intervals not exceeding 24 hours. The dosage of ALESSE-28 is one pink
tablet daily for 21 consecutive days, followed by one lightgreen inert
tablet daily for 7 consecutive days, according to the prescribed schedule.
It is recommended that ALESSE-28 tablets be taken at the same time each
day.
The dispenser should be kept in the wallet supplied to avoid possible
fading of the pills. If the pills fade, patients should continue to take
them as directed.
During The First Cycle Of Use
The possibility of ovulation and conception prior to initiation of medication
should be considered. The patient should be instructed to begin taking
ALESSE on either the first Sunday after the onset of menstruation (Sunday
Start) or on Day 1 of menstruation (Day 1 Start).
Sunday start
The patient is instructed to begin taking ALESSE-28 on the first Sunday
after the onset of menstruation. If menstruation begins on a Sunday,
the first tablet (pink) is taken that day. One pink tablet should be
taken daily for 21 consecutive days, followed by one light-green inert
tablet daily for 7 consecutive days. Withdrawal bleeding should usually
occur within 3 days following discontinuation of pink tablets and may
not have finished before the next pack is started. During the first cycle,
contraceptive reliance should not be placed on ALESSE-28 until a pink
tablet has been taken daily for 7 consecutive days, and a nonhormonal
back-up method of birth control should be used during those 7 days.
Day 1 start
During the first cycle of medication, the patient is instructed to begin
taking ALESSE-28 during the first 24 hours of her period (day one of
her menstrual cycle). One pink tablet should be taken daily for 21 consecutive
days, followed by one light-green inert tablet daily for 7 consecutive
days. Withdrawal bleeding should usually occur within 3 days following
discontinuation of pink tablets and may not have finished before the
next pack is started. If medication is begun on day one of the menstrual
cycle, no back-up contraception is necessary. If ALESSE-28 tablets are
started later than day one of the first menstrual cycle or postpartum,
contraceptive reliance should not be placed on ALESSE-28 tablets until
after the first 7 consecutive days of administration, and a nonhormonal
back-up method of birth control should be used during those 7 days.
After the first cycle of use
The patient begins her next and all subsequent courses of tablets on
the day after taking her last light-green tablet. She should follow the
same dosing schedule: 21 days on pink tablets followed by 7 days on light-green
tablets. If in any cycle the patient starts tablets later than the proper
day, she should protect herself against pregnancy by using a nonhormonal
back-up method of birth control until she has taken a pink tablet daily
for 7 consecutive days.
Switching from another hormonal method of contraception
When the patient is switching from a 21-day regimen of tablets, she
should wait 7 days after her last tablet before she starts ALESSE. She
will probably experience withdrawal bleeding during that week. She should
be sure that no more than 7 days pass after her previous 21-day regimen.
When the patient is switching from a 28-day regimen of tablets, she should
start her first pack of ALESSE on the day after her last tablet. She
should not wait any days between packs. The patient may switch any day
from a progestin-only pill and should begin ALESSE the next day. If switching
from an implant or injection, the patient should start ALESSE on the
day of implant removal or, if using an injection, the day the next injection
would be due. In switching from a progestin-only pill, injection, or
implant, the patient should be advised to use a nonhormonal back-up method
of birth control for the first 7 days of tablet-taking.
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occur, the patient is instructed
to continue on the same regimen. This type of bleeding is usually transient
and without significance; however, if the bleeding is persistent or prolonged,
the patient is advised to consult her physician.
Risk of pregnancy if tablets are missed
While there is little likelihood of ovulation occurring if only one
or two pink tablets are missed, the possibility of ovulation increases
with each successive day that scheduled pink tablets are missed. Although
the occurrence of pregnancy is unlikely if ALESSE is taken according
to directions, if withdrawal bleeding does not occur, the possibility
of pregnancy must be considered. If the patient has not adhered to the
prescribed schedule (missed one or more tablets or started taking them
on a day later than she should have), the probability of pregnancy should
be considered at the time of the first missed period and appropriate
diagnostic measures taken. If the patient has adhered to the prescribed
regimen and misses two consecutive periods, pregnancy should be ruled
out.
The risk of pregnancy increases with each active (pink) tablet missed.
For additional patient instructions regarding missed tablets, see the
WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING
section.
Use after pregnancy, abortion or miscarriage
ALESSE may be initiated no earlier than day 28 postpartum in the nonlactating
mother or after a second trimester abortion due to the increased risk
for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS
concerning thromboembolic disease). The patient should be advised to
use a non-hormonal back-up method for the first 7 days of tablet taking.
ALESSE may be initiated immediately after a first trimester abortion
or miscarriage. If the patient starts ALESSE immediately, back-up contraception
is not needed.
HOW SUPPLIED
ALESSE®-28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol)
are available in packages of 3 MINI-PACK™ dispensers of 28 tablets
each, NDC 0008-2576-02, as follows:
21 active tablets, NDC 0008-0912, pink, round tablet
marked “W” and “912”.
7 inert tablets, NDC 0008-0650, light-green, round
tablet marked “W” and “650”.
Store at controlled room temperature 20°to 25°C (68°to 77°F).
