"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Oral contraceptives 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 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.
TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
|Method||Perfect Use||Typical Use|
|Norplant® System (6 capsules)||0.1||0.1|
|Copper T 380A||0.6||0.8|
|Condom (male) without spermicide||3||12|
|(female) without spermicide||5||21|
|Diaphragm with spermicidal|
|cream or jelly||6||18|
|Spermicides alone (foam, creams, jellies, and vaginalsuppositories)||6||21|
|Periodic abstinence (all methods)||1-9*||20|
|No contraception (planned pregnancy)||85||85|
|NA - not available
*Depending on method (calendar, ovulation, symptothermal, post-ovulation)
Adapted from Hatcher RA et al., Contraceptive Technology, 16th Revised Edition. New York, NY: Irvington Publishers, 1994.
In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Aviane (levonorgestrel and ethinyl estradiol tablets) ™ (levonorgestrel and ethinyl estradiol tablets, USP 0.10 mg/0.02) 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 Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet for 7 consecutive days, according to the prescribed schedule.
It is recommended that Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 tablets be taken at the same time each day.
During the first cycle of medication, the patient is instructed to begin taking Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (orange) is taken that day. One orange 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 orange tablets. During the first cycle, contraceptive reliance should not be placed on Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 until an orange 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 orange 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 an orange tablet daily for 7 consecutive days.
Day 1 start
During the first cycle of medication, the patient is instructed to begin taking Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of orange tablets. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 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 Aviane (levonorgestrel and ethinyl estradiol tablets) ™. 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 Aviane (levonorgestrel and ethinyl estradiol tablets) ™ 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 orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled orange tablets are missed. Although the occurrence of pregnancy is unlikely if Aviane (levonorgestrel and ethinyl estradiol tablets) ™ 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 (orange) 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, Aviane (levonorgestrel and ethinyl estradiol tablets) ™ 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", "WARNINGS", and "PRECAUTIONS" concerning thromboembolic disease).
Aviane (levonorgestrel and ethinyl estradiol tablets) ™ –28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets, USP) are available in cartons of six dispenser cards of 28 tablets each, NDC 0555-9045-58, as follows: 21 active tablets, orange, round coated tablet marked "dp" and "016", 7 inert tablets, light-green, round tablet marked "dp" and "519".
Store at controlled room temperature 15°-30°C (59°-86°F) [See USP].
REFERENCES AVAILABLE UPON REQUEST.
MANUFACTURED BY BARR LABORATORIES, INC. POMONA, NY 10970. Revised Oct 2003. FDA Rev date: 10/31/2001
Last reviewed on RxList: 12/12/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Aviane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.