Drug Catalog - Product Detail
DESOGESTREL/ETHINYL ESTRADIOL (APRI) TB 0.15/0.03MG 6X28
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00555-9043-58 | TEVA PHARMACEUTICALS USA | 28 | 0.15-30MG-MCG | TABLET |
PACKAGE FILES
Generic Name
DESOGESTREL AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA075256
Description
DESCRIPTION Apri ® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel C 22 H 30 O M.W. 310.48 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 The 21 rose-colored tablets meet USP Dissolution Test 2. structural formula 1 structural formula 2
How Supplied
HOW SUPPLIED Apri ® (desogestrel and ethinyl estradiol tablets USP) 28 tablets blister cards contain 21 rose-colored, round, film-coated, unscored, biconvex, 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, USP. 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). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Indications & Usage
INDICATIONS AND USAGE Apri ® (desogestrel and ethinyl estradiol tablets USP) is 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 1 lists the typical accidental pregnancy rates for users of combined 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. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 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. Table 1: 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 c Method (1) Typical Use a (2) Perfect Use b (3) (4) Chance d 85 85 Spermicides e 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal f 2 Post-Ovulation 1 Withdrawal 19 4 Cap g Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm g 20 6 56 Condom h 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 Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. i Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. j Source: Trussel J. Contraceptive efficacy. 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. a. 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. b. 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. c. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. d. 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. e. Foams, creams, gels, vaginal suppositories, and vaginal film. f. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g. With spermicidal cream or jelly. h. Without spermicides. i. 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 ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 4 yellow pills). j. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Apri (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.
Dosage and Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Apri must be taken exactly as directed and at intervals not exceeding 24 hours. Apri is available in the Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided. Day 1 Start The dosage of Apri for the initial cycle of therapy is one rose-colored “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”. Tablets are taken without interruption as follows: One rose-colored “active” tablet daily for 21 days, then one white “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a rose-colored “active” tablet is taken the next day. The use of Apri for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. 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: Nursing Mothers .) If the patient starts on Apri postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a rose-colored “active” 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) rose-colored “active” tablet in Weeks 1, 2, or 3, the rose-colored “active” tablet should be taken as soon as she remembers. If the patient misses two (2) rose-colored “active” tablets in Week 1 or Week 2, the patient should take two (2) rose-colored “active” tablets the day she remembers and two (2) rose-colored “active” tablets the next day; and then continue taking one (1) rose-colored “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) rose-colored “active” tablets in the third week or misses three (3) or more rose-colored “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. Sunday Start When taking Apri, the first rose-colored “active” tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first rose-colored “active” tablet is taken on that day. If switching directly from another oral contraceptive, the first rose-colored “active” 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 “active” tablet daily for 21 days, then one white “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a rose-colored “active” 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 Apri 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: Nursing Mothers. ) If the patient starts on Apri postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a rose-colored “active” 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) rose-colored “active” tablet in Weeks 1, 2, or 3, the rose-colored “active” tablet should be taken as soon as she remembers. If the patient misses two (2) rose-colored “active” tablets in Week 1 or Week 2, the patient should take two (2) rose-colored “active” tablets the day she remembers and two (2) rose-colored “active” tablets the next day; and then continue taking one (1) rose-colored “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) rose-colored “active” tablets in the third week or misses three (3) or more rose-colored “active” tablets in a row, the patient should continue taking one rose-colored “active” 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.