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Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
21 pink active tablets each containing 0.10 mg of levonorgestrel, d(-)-13(beta)-ethyl-17(alpha)-ethinyl-17 (beta)-hydroxygon- 4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17(alpha)-ethinyl-1,3,5(10)-estratriene-3, 17(beta)-diol. The inactive ingredients present are cellulose, hydroxypropyl methylcellulose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and wax E.
7 light-green inert tablets, each containing cellulose, FD&C blue no. 1, hydroxypropyl methylcellulose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and wax E.
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Levonorgestrel
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See ALESSE™-21.
See ALESSE-21.
See ALESSE-21.
See ALESSE-21.
See ALESSE-21.
Drug Interactions: See ALESSE-21.
Carcinogenesis: See ALESSE-21.
Pregnancy: See ALESSE-21.
Nursing Mothers: See ALESSE-21.
Information for the Patient: See Alesse-21.
See Alesse-21.
See Alesse-21.
See Alesse-21.
To achieve maximum contraceptive effectiveness, Alesse™ must be taken exactly as directed and at intervals not exceeding 24 hours. 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.
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.
Sunday start:
During the first cycle of medication, 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 seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of pink tablets. 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. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on pink tablets--7 days on light-green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using another method of birth control until she has taken a pink tablet daily for 7 consecutive 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 seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of pink tablets. 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. The possibility of ovulation and conception prior to initiation of medication should be considered.
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.
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. 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 before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
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 below.
In the nonlactating mother, Alesse may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (See " Contraindications ", " ", and " Precautions " concerning thromboembolic disease).
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 "
" and "912".
7 inert tablets, NDC 0008-0650, light-green, round tablet marked "
" and "650".
Store at controlled room temperature 20°-25° C (68°-77° F).
References available upon request.
See Alesse-21.
See Alesse-21.
Manufactured by:
Wyeth Laboratories
A Wyeth-Ayerst Company
Philadelphia, PA 19101
CI 4844-2 Revised April 24, 1997
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