"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 I 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: PERCENTAGE OF WOMEN
EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A
|Method||Perfect Use||Typical Use|
|Depo-Provera® (injectable progestogen)||0.3||0.3|
|Copper T 380A||0.6||0.8|
|Condom (male) without spermicide||3||14|
|(Female) without spermicide||5||21|
|Diaphragm with spermicidal cream or jelly||6||20|
|Spermicides alone (foam, creams, jellies, and vaginal suppositories)||6||26|
|Periodic abstinence (all methods)||1-9a||25|
|No contraception (planned pregnancy)||85||85|
|NA - not available
a Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Nordette®-28 (levonorgestrel and ethinyl estradiol tablets, 0.15mg/0.03mg) must be taken exactly as directed and at intervals not exceeding 24 hours.
The dosage of Nordette®-28 is one light-orange tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule.
It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.
During the first cycle of medication, the patient is instructed to begin taking Nordette®-28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (light-orange) is taken that day. One light-orange tablet should be taken daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of light-orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Nordette®-28 until a light-orange 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. 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 light-orange tablets—7 days on pink inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a light-orange tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Nordette®-28. 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 Nordette®-28 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 Nordette®-28 the next day. If switching from an implant or injection, the patient should start Nordette®-28 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, 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. Although the occurrence of pregnancy is highly unlikely if Nordette®-28 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.
For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING below.
Any time the patient misses two or more light-orange tablets, she should also use another method of contraception until she has taken a light-orange tablet daily for seven consecutive days. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking light-orange tablets again on the proper day.
If breakthrough bleeding occurs following missed light-orange tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two light-orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled light-orange tablets are missed.
Nordette®-28 may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.
In the case of first trimester abortion, if the patient starts Nordette®-28 immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.
Nordette®-28 Tablets (levonorgestrel and ethinyl estradiol, 0.15mg/0.03mg) are available in packages of 6 compact dispensers, each containing 28 Tablets:
|21 Active Tablets:||Light-orange, round, unscored, debossed with 404 on one side and N on the other side.|
|7 Inert Tablets:||Pink, round, unscored, debossed with 405 on one side and N on the other side.|
Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature].
References available upon request.
Teva Women’S Health, Inc. Subsidiary of Teva Pharmaceuticals USA, Inc. Sellersville, PA 18960. Rev. 06/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/23/2013
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