"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"...
FEMCON Fe (norethindrone and ethinyl estradiol tablets) is 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 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE 2: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.
|% of Women Experiencing an Unintended Pregnancy within the First Year of Use||% of Women Continuing Use at One Year3|
|Method||Typical Use1||Perfect Use2|
|Copper T 380A||0.8||0.6||78|
|Norplant® and Norplant® 2||0.05||0.05||88|
| Emergency Contraceptive Pills: Treatment initiated
within 72 hours after unprotected intercourse reduces risk of pregnancy
by at least 75%9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception10
Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year
4 The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether
5 Foams, creams, gels, vaginal suppositories and vaginal film
6 Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases
7 With spermicidal cream or jelly
8 Without spermicides
9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills)
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of age
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, FEMCON Fe (norethindrone and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FEMCON Fe (norethindrone and ethinyl estradiol tablets) is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking FEMCON Fe (norethindrone and ethinyl estradiol tablets) on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on FEMCON Fe (norethindrone and ethinyl estradiol tablets) until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) 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 on which she began her first course, following the same schedule: 21 days on white tablets-7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white 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 FEMCON Fe (norethindrone 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 FEMCON Fe (norethindrone and ethinyl estradiol tablets) 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 FEMCON Fe (norethindrone and ethinyl estradiol tablets) the next day. If switching from an implant or injection, the patient should start FEMCON Fe (norethindrone and ethinyl estradiol tablets) on the day of implant removal or, if using an injection, the day the next injection would be due.
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 healthcare provider. Although pregnancy is unlikely if FEMCON Fe (norethindrone 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. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white
tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.
FEMCON Fe (norethindrone and ethinyl estradiol tablets) may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. 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). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. FEMCON Fe (norethindrone and ethinyl estradiol tablets) may be initiated after a first-trimester abortion; if the patient starts FEMCON Fe (norethindrone and ethinyl estradiol tablets) immediately, additional contraceptive measures are not needed.
For additional patient instructions regarding complete dosing instructions, see the "HOW TO TAKE THE PILL" section in the DETAILED PATIENT LABELING.
FEMCON® Fe (norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets) is available only in a 28-day regimen. Each package contains 21 round, white tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, imprinted with W|C on one side and 581 on the other. Each brown, round tablet contains 75 mg ferrous fumarate, imprinted with PD 622 on one side.
FEMCON® Fe (norethindrone and ethinyl estradiol tablets)
N 0430-0482-14 Carton of 5 Blister Cards of 28 Tablets Each
Store at 25° C (77° F); excursions permitted to 15°- 30° C (59°- 86° F) [see USP Controlled Room Temperature]
References are available upon request.
Manufactured by: Warner Chilcott Company, Inc. Fajardo, PR 00738. Marketed by: Warner Chilcott (US), LLC, Rockaway, NJ 07866. 1-800-521-8813. Revised January 2008. FDA rev date: 1/9/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/29/2008
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