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Sprintec

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Sprintec

Sprintec

INDICATIONS

Sprintec (norgestimate and ethinyl estradiol tablets) 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 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 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  
  Sympto-Thermal6   2  
  Post-Ovulation   1  
Withdrawal 19 4  
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
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
Adapted from Hatcher et al., 1998 Ref. #1.
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 one year.
4The 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.
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.

In clinical trials with norgestimate and ethinyl estradiol, 1,651 subjects completed 24,272 cycles and a total of 18 pregnancies were reported. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 0.96 per 100 women-years. This rate includes patients who did not take the drug correctly.

DOSAGE AND ADMINISTRATION

Oral Contraception

To achieve maximum contraceptive effectiveness, Sprintec (norgestimate and ethinyl estradiol tablets) Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Sprintec (norgestimate and ethinyl estradiol tablets) Tablets are available in the Blister Pack Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.

28-Day Regimen (Sunday Start)

When taking Sprintec (norgestimate and ethinyl estradiol tablets) 28 Tablets, the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one white tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first seven consecutive days of administration.

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 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.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

28-Day Regimen (Day 1 Start)

The dosage of Sprintec (norgestimate and ethinyl estradiol tablets) 28 Tablets, for the initial cycle of therapy is one active tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one white tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

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.

Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

The use of Sprintec (norgestimate 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") The possibility of ovulation and conception prior to initiation of medication should be considered.

(See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

Additional Instructions For All Dosing Regimens

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

Sprintec™ 28 (norgestimate and ethinyl estradiol tablets 0.250 mg/0.035 mg) are packaged in cartons of six blister cards. Each card contains 21 blue tablets and 7 white tablets containing inert ingredients. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are round, unscored tablets, debossed b on one side and 987 on the other side. Each white tablet contains inert ingredients and has a debossed b on one side and 143 on the other side. (NDC 0555-9016-58).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

MANUFACTURED BY BARR LABORATORIES, INC. POMONA, NY 10970. Revised OCTOBER 2002. FDA Rev date: 9/25/2002

Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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