Lutera 28 Day Pack
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II 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 Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with Lutera, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. table 2
Physicians Total Care, Inc.
ROUND ORANGE Watson P1
Watson P1 ROUND ORANGE
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HOW SUPPLIED Lutera® tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser - NDC 54868-6210-0, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: 21 active tablets: white, round tablet debossed with “WATSON” on one side and “949” on the other side. 7 inert tablets: peach, round tablet debossed with “WATSON” on one side and “P1” on the other side. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature].
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