Ortho Tri-Cyclen

[Noregestimate/Ethinyl Estradiol]

HOW SUPPLIED

ORTHO TRI-CYCLEN

28 Tablets are available in a DIALPAK ® Tablet Dispenser (NDC 0062-1903-15) containing 28 tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic com-pound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each green tablet contains inert ingredients.

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The white tablets are unscored, with "Ortho" and "180" debossed on each side; the light blue tablets are unscored with "Ortho" and "215" debossed on each side; the blue tablets are unscored with "Ortho" and "250" debossed on each side. ORTHO TRI-CYCLEN 28 Tablets are also available as Refills (NDC 0062-1903-23) ORTHO TRI-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE ® Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1903-20).

ORTHO-CYCLEN 28 Tablets are available in a DIALPAK ® Tablet Dispenser (NDC 0062-1901-15) contain-ing 28 tablets as follows: 21 blue tablets and 7 green tablets. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estra-diol which are unscored with "Ortho" and "250" debossed on each side. Each green tablet contains inert ingredients. ORTHO-CYCLEN 28 Tablets are also available as Refills (NDC 0062-1901-23) ORTHO-CYCLEN 28 Tablets are available for clinic usage in a VERIDATE ® Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1901-20).
® only

REFERENCES

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52. Henderson BE, Preston-Martin S, Edmondson HA, Peters RL, Pike MC. Hepatocellular carcinoma and oral contraceptives. Br J Cancer 1983; 48: 437-440.

53. Neuberger J, Forman D, Doll R, Williams R. Oral contraceptives and hepatocellular car-cinoma. Br Med J 1986; 292: 1355-1357.

54. Forman D, Vincent TJ, Doll R. Cancer of the liver and oral contraceptives. Br Med J 1986; 292: 1357-1361.

55. Harlap S, Eldor J. Births following oral contraceptive failures. Obstet Gynecol 1980; 55: 447- 452.

56. Savolainen E, Saksela E, Saxen L. Teratogenic hazards of oral contraceptives analyzed in a national malformation register. Am J Obstet Gynecol 1981; 140: 521-524.

57. Janerich DT, Piper JM, Glebatis DM. Oral contraceptives and birth de-fects. Am J Epidemiol 1980; 112: 73-79.

58. Ferencz C, Matanoski GM, Wilson PD, Rubin JD, Neill CA, Gutberlet R. Maternal hormone therapy and congenital heart disease. Teratology 1980; 21: 225-239.

59. Rothman KJ, Fyler DC, Goldblatt A, Kreidberg MB. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol 1979; 109: 433-439.

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61. Royal College of General Practitioners: Oral contraceptives and health. New York, Pittman 1974.

62. Layde PM, Vessey MP, Yeates D. Risk of gall-bladder disease: a cohort study of young women attending family planning clinics. J Epidemiol Community Health 1982; 36: 274-278.

63. Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO): Prevalence of gallstone disease in an Italian adult female population. Am J Epidemiol 1984; 119: 796-805.

64. Storm BL, Tamragouri RT, Morse ML, Lazar EL, West SL, Stolley PD, Jones JK. Oral contraceptives and other risk factors for gallbladder disease. Clin Pharmacol Ther 1986; 39: 335-341.

65. Wynn V, Adams PW, Godsland IF, Melrose J, Niththyananthan R, Oakley NW, Seedj A. Comparison of ef-fects of different combined oral contraceptive formulations on carbohydrate and lipid metabolism. Lancet 1979; 1: 1045- 1049.

66. Wynn V. Effect of progesterone and progestins on carbohydrate metabolism. In: Progesterone and Progestin. Bardin CW, Milgrom E, Mauvis-Jarvis P. eds. New York, Raven Press 1983; pp. 395-410.

67. Perlman JA, Roussell-Briefel RG, Ezzati TM, Lieberknecht G. Oral glucose tolerance and the potency of oral contraceptive progestogens. J Chronic Dis 1985; 38: 857- 864.

68. Royal College of General Practitioners' Oral Contraception Study: Effect on hypertension and benign breast disease of progestogen component in combined oral contraceptives. Lancet 1977; 1: 624.

69. Fisch IR, Frank J. Oral contraceptives and blood pressure. JAMA 1977; 237: 2499-2503.

70. Laragh AJ. Oral contraceptive induced hypertension Ð nine years later. Am J Obstet Gynecol 1976; 126: 141-147.

71. Ramcharan S, Peritz E, Pellegrin FA, Williams WT. Incidence of hypertension in the Walnut Creek Contraceptive Drug Study cohort: In: Pharmacology of steroid contraceptive drugs. Garattini S, Berendes HW. eds. New York, Raven Press, 1977; pp. 277-288, (Monographs of the Mario Negri Institute for Pharmacological Research Milan.)

72. Stockley I. Interactions with oral contraceptives. J Pharm 1976; 216: 140-143.

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74. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development: Combination oral con-traceptive use and the risk of endometrial cancer. JAMA 1987; 257: 796-800.

75. Ory HW. Functional ovarian cysts and oral contraceptives: negative association confirmed surgically. JAMA 1974; 228: 68-69.

76. Ory HW, Cole P, MacMahon B, Hoover R. Oral contraceptives and reduced risk of benign breast disease. N Engl J Med 1976; 294: 419-422.

77. Ory HW. The non-contraceptive health benefits from oral contraceptive use. Fam Plann Perspect 1982; 14: 182-184.

78. Ory HW, Forrest JD, Lincoln R. Making choices: evaluating the health risks and benefits of birth control methods. New York, The Alan Guttmacher Institute, 1983; p. 1.

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80. Hennekens CH, Speizer FE, Lipnick RJ, Rosner B, Bain C, Belanger C, Stampfer MJ, Willett W, Peto R. A case-control study of oral contraceptive use and breast cancer. JNCI 1984; 72: 39-42.

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85. Miller DR, Rosenberg L, Kaufman DW, Stolley P, Warshauer ME, Shapiro S. Breast cancer before age 45 and oral contraceptive use: New findings. Am J Epidemiol 1989; 129: 269-280.

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87. Schlesselman JJ. Cancer of the breast and reproductive tract in relation to use of oral contraceptives. Contraception 1989; 40: 1-38.

88. Vessey MP, McPherson K, Villard-Mackintosh L, Yeates D. Oral contraceptives and breast cancer: latest findings in a large cohort study. Br J Cancer 1989; 59: 613-617.

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90. Anderson FD. Selectivity and minimal androgenicity of norges-timate in monophasic and triphasic oral contraceptives. Acta Obstet Gynecol Scand 1992; 156 (Supplement): 15-21.

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BRIEF SUMMARY PATIENT PACKAGE INSERT

Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy. ORTHO TRI-CYCLEN may also be taken to treat moderate acne in females who are able to use the pill. When taken correctly to prevent pregnancy, oral contraceptives have a failure rate of less than 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is 5% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be fatal or may cause temporary or permanent dis-ability.
The risks associated with taking oral contraceptives increase significantly if you:
° smoke
° have high blood pressure, diabetes, high cholesterol
° have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice or malignant or benign liver tumors.
Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.

2. In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.

3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped. The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.

There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility pills may cause such cancers.

Taking the combination pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physi-cal examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. Your pharmacist should have given you the detailed patient information labeling which gives you further information which you should read and discuss with your health care provider.

ORTHO-CYCLEN and ORTHO TRI-CYCLEN (like all oral contraceptives) are intended to prevent pregnancy. ORTHO TRI-CYCLEN is also used to treat moderate acne in females who are able to take oral contracep-tives. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

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