Ortho TriCyclen Lo 28 Day Pack ethinyl estradiol 0.025 mg norgestimate 0.215 mg

INDICATIONS AND USAGE ORTHO TRI-CYCLEN ® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN ® Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN ® Lo users. 99 This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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 methods can result in lower failure rates. Table 2: 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 Typical Use Perfect Use (1) (2) (3) (4) Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 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). Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Source: Trussell 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. 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 Cap With spermicidal cream or jelly. Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Condom 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 ORTHO TRI-CYCLEN ® Lo has not been studied for and is not indicated for use in emergency contraception.

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FDA Reported Adverse Reactions
[1] fatigue    [2] nausea    [3] anaemia    [4] drug ineffective    [5] headache    [6] toxicity to various agents    [7] rash    [8] vomiting    [9] diarrhoea    [10] dyspnoea