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Apri

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Apri

Apri

INDICATIONS

Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, 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 One Year*
Method
(1)
Typical Use†
(2)
Perfect Use‡
(3)
(4)
Chance§ 85 85  
Spermicides¶ 26 6 40
Periodic abstinence 25   63
Calendar   9  
Ovulation method   3  
Sympto-thermal#   2  
Post-ovulation   1  
Withdrawal 19 4  
CapȚ      
Parous women 40 26 42
Nulliparous women 20 9 56
Sponge      
Parous women 40 20 42
Nulliparous women 20 9 56
DiaphragmȚ 20 6 56
Condomß      
Female (Reality) 21 5 56
Male 14 3 61
Pill 5   71
Progestin only   0.5  
Combined   0.1  
IUD:      
Progesterone T 2 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 0.1 100
Adapted from Hatcher et al, 1998, Ref #1.
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
† 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.
‡ 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.
§ 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.
¶ Foams, creams, gels, vaginal suppositories, and vaginal film.
# Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
Þ With spermicidal cream or jelly.
ß Without spermicides.

In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.

DOSAGE AND ADMINISTRATION

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

NOTE: Each cycle pack blister card 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 blister card 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.

28-Day Regimen (Day 1 Start):

The dosage of the Apri (desogestrel and ethinyl estradiol tablets) Tablet 28-Day Regimen for the initial cycle of therapy is one tablet administered daily from the 1st day through 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One rose-colored tablet daily for 21 days, then one white tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a rose-colored tablet is taken the next day.

The use of the Apri (desogestrel and ethinyl estradiol tablets) Tablet 28-Day Regimen 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 Apri (desogestrel and ethinyl estradiol tablets) tablets postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a rose-colored tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

28-Day Regimen (Sunday Start):

When taking the Apri (desogestrel and ethinyl estradiol tablets) Tablet 28-Day Regimen, the first rose-colored tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first rose-colored tablet is taken on that day. If switching directly from another oral contraceptive, the first rose-colored tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One rose-colored tablet daily for 21 days, then one white tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a rose-colored tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

The use of the Apri (desogestrel and ethinyl estradiol tablets) Tablet 28-Day Regimen for contraception may be initiated 4 weeks postpartum. 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 Apri (desogestrel and ethinyl estradiol tablets) tablets postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a rose-colored tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

ALL ORAL CONTRACEPTIVES:

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation 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 discontinued until pregnancy is ruled out.
  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

HOW SUPPLIED

Apri (desogestrel and ethinyl estradiol) Tablet 28 Day Regimen blister cards contain 21 round, unscored, rose-colored tablets and 7 round, unscored white tablets. Each rose-colored tablet (debossed with "dp" on one side and "575" on the other side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each white tablet (debossed with "dp" on one side and "570" on the other side) contains inert ingredients.

Cartons of 6 blister cards NDC 0555-9043-58.

STORAGE: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

MANUFACTURED BY: BARR LABORATORIES, INC. POMONA, NY 10970, Apri (desogestrel and ethinyl estradiol tablets) l 2004. FDA rev date: n/a

Last reviewed on RxList: 3/19/2008
This monograph has been modified to include the generic and brand name in many instances.

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