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Drug Information for Junel ™ 21 Day (norethindrone acetate and ethinyl estradiol tablets, USP) Junel ™ Fe28 Day (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay. (BARR LABORATORIES, INC.): INDICATIONS AND USAGE
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- Information for the patient
- ADVERSE REACTIONS
- NON-CONTRACEPTIVE HEALTH BENEFITS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- BRIEF SUMMARY PATIENT PACKAGE INSERT
- DETAILED PATIENT PACKAGE INSERT
- External Links Related to Junel ™ 21 Day (norethindrone acetate and ethinyl estradiol tablets, USP) Junel ™ Fe28 Day (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay. (BARR LABORATORIES, INC.)
Junel ™ 21 and Junel ™Fe 28 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 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method LowestExpectedThe authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. TypicalThis term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. (No contraception) (85) (85) Oral contraceptives combined progestin only 0.10.5 3N/AN/A--Data not availableN/A Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge nulliparous parous 920 2040 Implant 0.05 0.05 Injection: depot medroxyprogesterone acetate 0.3 0.3 IUD progesterone T copper T 380A LNg 20 18.104.22.168 2.00.80.1 Condom without spermicides female male 53 2114 Cervical Cap with spermicidal cream or jelly nulliparous parous 926 2040 Periodic abstinence (all methods) 1-9 25 Withdrawal 4 19 Female sterilization 0.5 0.5 Male sterilization 0.10 0.15
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