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Desogen

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Desogen

INDICATIONS

Desogen® (desogestrel and ethinyl estradiol tablets) (desogestrel and ethinyl estradiol) Tablets 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, the IUD, and the NORPLANT® System, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

TABLE I: 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
Method
(1)
Typical Use1 (2) Perfect Use2
(3)
One Year3
(4)
Chance4 85 85  
Spermicides5 26 6 40
Periodic abstinence 25   63
  Calendar   9  
  Ovulation Method   3  
  Sympto-Thermal6   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 T 380A 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 Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
9
Lactation Amenorrhea Method: LAM is a highly effective temporary method of contraception.10
Adapted from Hatcher et al., Contraceptive Technology, 17th 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 percents 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.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory 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 FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (one dose is two white pills), Alesse (one dose is five pink pills), Nordette or Levlen (one dose is four yellow pills). Two FDA-approved products for emergency contraception include Plan B® and Preven®.a,b
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 breast-feeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
a Plan B® [package insert]. Washington DC: Women's Capital Corporation.
b
Preven® [package insert]. Somerville, NJ: Gynetics Inc;1998.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Desogen® (desogestrel and ethinyl estradiol tablets) (desogestrel and ethinyl estradiol) Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Desogen® (desogestrel and ethinyl estradiol tablets) may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen.

Six different "day label strips" are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Desogen® (desogestrel and ethinyl estradiol tablets) should be considered.

The use of Desogen® (desogestrel and ethinyl estradiol tablets) for contraception may be initiated 4 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers").

If the patient starts on Desogen® (desogestrel and ethinyl estradiol tablets) postpartum, and has not yet had a period, she should be instructed to use another method of contra-ception, such as condoms, diaphragms, or spermicides, until a white tablet has been taken daily for 7 days.

SUNDAY START

When initiating a Sunday start regimen, another method of contra-ception, such as condoms, diaphragms, or spermicides, should be used until after the first 7 consecutive days of administration.

Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 green (inert) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green tablet. [If switching from a different Sunday Start oral contraceptive, the first Desogen® (desogestrel and ethinyl estradiol tablets) (desogestrel and ethinyl estradiol) tablet should be taken on the same day that a new pack of the previous oral contra-ceptive would have been started.]

If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control, such as condoms, diaphragms, or spermi-cides, if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control, such as condoms, diaphragms, or spermicides, if she has intercourse in the 7 days after missing pills.

DAY 1 START

Counting the first day of menstruation as "Day 1", tablets are taken without interruption as follows: One white tablet daily for 21 days, then one green (inert) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.]

If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control, such as condoms, diaphragms, or spermi-cides, if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control, such as condoms, diaphragms, or spermicides, if she has intercourse in the 7 days after missing pills.

ALL ORAL CONTRACEPTIVES

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In break-through bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiag-nosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

  1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discon-tinued if pregnancy is confirmed.
  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

HOW SUPPLIED

Desogen® (desogestrel and ethinyl estradiol tablets) (desogestrel and ethinyl estradiol) Tablets contain 21 round white tablets and 7 round green tablets in a blister card within a recyclable plastic dispenser. Each white tablet (debossed with "T5R" on one side and "Organon" on the other side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each green tablet (debossed with "K2H" on one side and "Organon" on the other side) contains inert ingredients.

Boxes of 6 NDC 0052-0261-06

STORAGE: Store below 86°F (30°C)

Manufactured for Organon USA Inc., West Orange, NJ 07052 by N.V. Organon, Oss, The Netherlands or Organon (Ireland) Ltd., Swords, Co. Dublin, Ireland
FDA rev date: 6/7/2007

Last reviewed on RxList: 7/9/2007
This monograph has been modified to include the generic and brand name in many instances.

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