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Estrostep Fe

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Estrostep Fe

Indications
Dosage
How Supplied

INDICATIONS

ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females, 15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, 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
(1)
Typical Use1
(2)
Perfect Use2
(3)
(4)
Chance4 85 85  
Spermicides5 26 6 40
Periodic Abstinence 25   63
  Calendar   9  
  Ovulation Method   3  
  Symptothermal6   2  
  Post-ovulation   1  
Cap7      
  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge      
  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragm7 20 6 56
Withdrawal 19 4  
Condom8      
  Female (Reality) 21 5 56
  Male 14 3 61
Pill 5   71
  Progestin Only   0.5  
  Combined   0.1  
IUD      
  Progesterone T 2.0 1.5 81
  Copper T380A 0.8 0.6 78
  LNg 20 0.1 0.1 81
Depo-Provera® 0.3 0.3 70
Norplant® and Norplant-2® 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
1Among 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.
2Among 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.
3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
4The percentages becoming pregnant 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% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5Foams, creams, gels, vaginal suppositories, and vaginal film.
6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7With spermicidal cream or jelly.
8Without spermicides.
9The 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 4 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).
10However, 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 6 months of age.

ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied.

Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population

  ESTROSTEP Fe
N= 296
Placebo
N= 295
Difference in Counts Between ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) and Placebo at Six Months
(95% CI)**
Number of Lesions Counts % reduction Counts % reduction  
INFLAMMATORY LESIONS
  Baseline Mean 29   29    
  Six Month Mean 14 52% 17 41% 3 (2)
NON-INFLAMMATORY LESIONS
  Baseline Mean 44   43    
  Six Month Mean 27 38% 32 25% 5 (±3.5)
TOTAL LESIONS
  Baseline Mean 74   72    
  Six Month Mean 42 43% 49 32% 7 (±5)
*Numbers rounded to nearest integer
**Limits for 95% Confidence Interval; not adjusted for baseline differences

ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.

Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) and Placebo (Statistically significant differences were not found in both studies individually until cycle 6)

Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of ESTROSTEP Fe and Placebo -  Illustration

DOSAGE AND ADMINISTRATION

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered.

Dosage and Administration for 28-Day Dosage Regimen

To achieve maximum contraceptive effectiveness, ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) should be taken exactly as directed and at intervals not exceeding 24 hours.

ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) provides a continuous administration regimen consisting of 21 white oral contraceptive tablets and seven brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days”.

Sunday-Start Regimen: The patient begins taking the first white tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white tablet is taken on the same day. The patient takes one white tablet daily for 21 days. The last white tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 white tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white tablet in the top row. Adhering to this regimen of one white tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday.

Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one white tablet daily, beginning with the first white tablet in the top row. After the last white tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet dispenser. Following this regimen of 21 white tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.

Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration

Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white tablets, continue medication without interruption.

If the patient forgets to take one or more white tablets, the following is suggested:

  • One tablet is missed
  • take tablet as soon as remembered
  • take next tablet at the regular time

Two consecutive tablets are missed (Week 1 or Week 2)

  • take two tablets as soon as remembered
  • take two tablets the next day
  • use another birth control method for seven days following the missed tablets

Two consecutive tablets are missed (Week 3)

Sunday-Start Regimen:

  • take one tablet daily until Sunday
  • discard remaining tablets
  • start new pack of tablets immediately (Sunday)
  • use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

  • discard remaining tablets
  • start new pack of tablets that same day
  • use another birth control method for seven days following the missed tablets

Three (or more) consecutive tablets are missed

Sunday-Start Regimen:

  • take one tablet daily until Sunday
  • discard remaining tablets
  • start new pack of tablets immediately (Sunday)
  • use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

  • discard remaining tablets
  • start new pack of tablets that same day
  • use another birth control method for seven days following the missed tablets

The possibility of ovulation occurring increases with each successive day that scheduled white tablets are missed. While there is little likelihood of ovulation occurring if only one white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white tablets are missed.

If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white tablet was taken.

In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day 1) depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

Use of Oral Contraceptives in the Event of a Missed Menstrual Period

  1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.
  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

Acne

The timing of initiation of dosing with ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) for acne should follow the guidelines for use of ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section for oral contraceptives.

HOW SUPPLIED

ESTROSTEP® Fe is available in dispensers each containing 21 white tablets. The first five triangle tablets each contain 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol; the next seven square tablets each contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol; the next nine round tablets each contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol; and the last seven (brown) tablets each contain 75 mg ferrous fumarate. Available in packages of five dispensers.

ESTROSTEP® Fe

N 0430-0570-14 Carton of 5 Tablet Dispensers

Storage-Do not store above 25° C (77° F). Protect from light. Store tablets inside pouch when not in use.

Manufactured by: Warner Chilcott Company, Inc. Fajardo, Puerto Rico 00738. Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866. Direct Medical Inquiries to: Warner Chilcott (US), Inc. 100 Enterprise Drive Rockaway, NJ 07866, Attn: Medical Affairs Department, 0570G013. Revised August 2007. FDA rev date: 6/14/2002.

Last reviewed on RxList: 4/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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