Alesse-28 instructions for administration

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Instructions for administration

Overview

During the first cycle of use

Sunday start

Day 1 start

After the first cycle of use

Switching from another hormonal method of contraception

If spotting or breakthrough bleeding occurs

Risk of pregnancy if tablets are missed

Use after pregnanc/abortion/miscarriage

What to do if you miss pills

• If you MISS 1 pink "active" pill
• If you MISS 2 pink "active" pills in a row in WEEK 1 OR WEEK 2
• If you MISS 2 pink "active" pills in a row in THE 3rd WEEK
• If you MISS 3 OR MORE pink "active" pills in a row (during the first 3 weeks)
• If you forget any of the 7 light-green "reminder" pills in Week 4

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Overview

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 light-green 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. Return to top

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). Return to top

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. Return to top

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. Return to top

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. Return to top

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. Return to top

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. Return to top

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. Return to top

Use after pregnancy/abortion/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. 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. Return to top

What to do if you miss pills

Alesse may not be as effective if you miss pink “active” pills, and particularly if you miss the first few or the last few pink “active” pills in a pack. Return to top

If you MISS 1 pink "active" pill

1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
2. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

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If you MISS 2 pink "active" pills in a row in WEEK 1 OR WEEK 2

1. Take 2 pills on the day you remember and 2 pills the next day.
2. Then take 1 pill a day until you finish the pack.
3. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

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If you MISS 2 pink "active" pills in a row in THE 3rd WEEK

• If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.
• If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
• You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

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If you MISS 3 OR MORE pink "active" pills in a row (during the first 3 weeks)

• If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day.
• If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant.
• You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

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If you forget any of the 7 light-green "reminder" pills in Week 4

• THROW AWAY the pills you missed.
• Keep taking 1 pill each day until the pack is empty.
• You do not need a back-up nonhormonal birth-control method if you start your next pack on time.

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Adapted from the FDA Package Insert.