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ALESSE (levonorgestrel, ethinyl estradiol) Dosage And Administration

Dosage And Administration

Recommended Dose and Dosage Adjustment

CONTRACEPTION:

ALESSE® 21 TABLETS REGIMEN:
Each cycle consists of 21 days on medication and a 7-day interval without medication (three weeks on, one week off).

The dosage of ALESSE Tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule. For the first cycle of medication, the patient is instructed to take one ALESSE Tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1. The tablets are then discontinued for seven days (one week). Withdrawal bleeding should usually occur within three days following discontinuation of ALESSE.

The patient begins her next and all subsequent 21-day courses of ALESSE Tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets seven days after discontinuation, regardless of whether or not withdrawal bleeding is still in progress.

ALESSE® 28 TABLETS REGIMEN:
Each cycle consists of 21 days of pink ALESSE Tablets (active tablets) followed by 7 days of white inert tablets (three weeks on ALESSE, one week on inert tablets).

The dosage of ALESSE Tablets is one tablet daily for 21 consecutive days per menstrual cycle, according to prescribed schedule, followed by one inert tablet daily for 7 consecutive days according to prescribed schedule. For the first cycle of medication, the patient is instructed to take one pink tablet daily for 21 consecutive days beginning on Day 1 of her menstrual cycle, on Day 5, or on the first Sunday after her period begins. (For the first cycle only, the first day of menstrual flow is considered Day 1). One white tablet is taken daily for the following seven consecutive days. Withdrawal bleeding should usually occur within three days following the discontinuation pink ALESSE® Tablets, i.e., during the week the patient is taking the white inert tablets.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week that she began her first course. She continues her next course of 28 tablets immediately after the last course, regardless of whether or not a period of withdrawal bleeding is still in progress. There is no need for the patient to count days between cycles because there are no "off-tablet days".

ACNE
The timing of initiation of ALESSE treatment for acne should follow the instructions for use of ALESSE for contraception (see the DOSAGE AND ADMINISTRATION information for oral contraception).

Missed Dose

The patient should be instructed to use the following chart if she misses one or more of her birth control pills. She should be told to match the number of pills with the appropriate starting time for her type of pill.

SUNDAY STARTOTHER THAN SUNDAY START
Miss One PillMiss One Pill
Take it as soon as you remember, and take the
next pill at the usual time. This means that you
might take two pills in one day.
Take it as soon as you remember, and take the
next pill at the usual time. This means that you
might take two pills in one day.
Miss Two Pills in a Row

Miss Two Pills in a Row

First two weeks
  1. Take two pills the day you remember and two pills the next day.
  2. Then take one pill a day until you finish the pack.
  3. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.

Third week

  1. Keep taking one pill a day until Sunday.
  2. On Sunday, safely discard the rest of the pack and start a new pack that day.
  3. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.
  4. You may not have a period this month.


If You Miss Two Periods in a Row, Call Your Doctor or Clinic.

First two weeks
  1. Take two pills the day you remember and two pills the next day.
  2. Then take one pill a day until you finish the pack.
  3. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.

Third week

  1. Safely dispose of the rest of the pill pack and start a new pack that same day.
  2. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.
  3. You may not have a period this month.


If You Miss Two Periods in a Row, Call Your Doctor or Clinic.

Miss Three or More Pills in a RowMiss Three or More Pills in a Row
Anytime in the cycle
  1. Keep taking one pill a day until Sunday.
  2. On Sunday, safely discard the rest of the pack and start a new pack that day.
  3. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.
  4. You may not have a period this month.


If You Miss Two periods in a Row, Call Your Doctor or Clinic.

Anytime in the cycle

  1. Safely dispose of the rest of the pill pack and start a new pack that same day.
  2. Use a nonhormonal back-up method of birth control if you have sex in the seven days after you miss the pills.
  3. You may not have a period this month.


If You Miss Two Periods in a Row, Call Your Doctor or Clinic.

Contraceptive reliability may be reduced if active tablets are missed and particularly if the missed tablets extend the tablet-free interval. If active tablets were missed and intercourse took place in the week before the tablets were missed, the possibility of pregnancy should be considered.

Administration

Tablets for oral use.

SPECIAL NOTES ON ADMINISTRATION

Administration

It is recommended that ALESSE® Tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

ALESSE is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle.

If ALESSE Tablets administration is initiated postpartum (no earlier than day 28 after delivery in the nonlactating mother) or after Day 1 of the first menstrual cycle, contraceptive reliance should not be placed on ALESSE until after the first seven consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered. Therefore, nonhormonal methods of contraception (such as condoms and spermicide) should be used for the first 7 days of tablet taking.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding usually is transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Advice in case of vomiting and/or diarrhea

If vomiting and/or diarrhea occurs within 4 hours after tablet-taking, tablet absorption may be incomplete. In such event, advice concerning the Management of Missed Tablet is outlined in the above chart. The woman must take the extra active tablet(s) needed from a backup pack.

No hormonal contraceptive use in the past month

Tablet-taking should start on day 1 of the woman’s natural cycle (ie, the first day of her menstrual bleeding). Starting on days 2-7 is allowed, but for the first 7 days of tablet-taking during the first cycle, a nonhormonal back-up method of birth control (such as condoms and spermicide) is recommended.

Changing from another COC pill

The woman should start ALESSE preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet interval of her previous COC.

Changing from a progestin only method (progestin-only pill, implant, intrauterine device [IUD], injection)

The woman may switch any day from the progestin-only pill and should begin ALESSE the next day. She should start ALESSE on the day that a progestin-only implant or a progestin-only IUD is removed. Alesse use should begin on the day that the next progestin-only injection is scheduled. In all of these situations, the woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking.

Following first-trimester abortion

The woman may start ALESSE immediately. Additional contraceptive measures are not needed.

Following delivery or second-trimester abortion

Since the immediate post-partum period is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than day 28 after delivery in the nonlactating mother or after second-trimester abortion. The woman should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of pregnancy should be ruled out before the actual start of COC use or the woman must wait for her first menstrual period.

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