Información de la droga para WATSON PHARMARevised: June 2005IN-5260/SPHYSICIAN LABELING Brevicon (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg) Norinyl 1+35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) Norinyl 1+50 (Norethindrone and Mestranol Tablets USP, 1 mg/0.05 mg) Rx Only (Watson Pharma, Inc.): HOW SUPPLIED

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  • Brevicon® (norethindrone and ethinyl estradiol tablets USP) are packaged in cartons of 3 tablet dispensers. Each dispenser contains 21 blue active tablets, round in shape with Watson debossed on one side and 254 on the other side and 7 orange inert tablets. The 7 orange inert tablets are round in shape with Watson debossed on one side and P1 on the other side.

    Norinyl®1+35 (norethindrone and ethinyl estradiol tablets USP) are packaged in cartons of 3 and 6 tablet dispensers. Each dispenser contains 21 yellow-green active tablets, round in shape with Watson debossed on one side and 259 on the other side and 7 orange inert tablets. The 7 orange inert tablets are round in shape with Watson debossed on one side and P1 on the other side.

    Norinyl®1+50 (norethindrone and mestranol tablets USP) are packaged in cartons of 3 and 6 tablet dispensers. Each dispenser contains 21 white active tablets, round in shape with Watson debossed on one side and 265 on the other side and 7 orange inert tablets. The 7 orange inert tablets are round in shape with Watson debossed on one side and P1 on the other side.

    Store at controlled room temperature 15-25°C (59-77°F).

  • REFERENCES

    • Trussell J. Contraceptive Efficacy Table from Hatcher R.A., Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, in Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.

    • Mann, J., et al.: Br Med J 2(5956):241-245, 1975.

    • Knopp, R.H.: J Reprod Med 31(9):913-921, 1986.

    • Mann, J.I., et al.: Br Med J 2:445-447, 1976.

    • Ory, H.: JAMA 237:2619-2622, 1977.

    • The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 249(2):1596-1599, 1983.

    • The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 257(6):796-800, 1987.

    • Ory, H.W.: JAMA 228(1):68-69, 1974.

    • Ory, H.W., et al.: N Engl J Med 294:419-422, 1976.

    • Ory, H.W.: Fam Plann Perspect 14:182-184, 1982.

    • Ory, H.W., et al.: Making Choices, New York, The Alan Guttmacher Institute, 1983.

    • Stadel, B.: N Engl J Med 305(11):612-618, 1981.

    • Stadel, B.: N Engl J Med 305(12):672-677, 1981.

    • Adam, S., et al.: Br J Obstet Gynaecol 88:838-845, 1981.

    • Mann, J., et al.: Br Med J 2(5965):245-248, 1975.

    • Royal College of General Practitioners' Oral Contraceptive Study: Lancet 1:541-546, 1981.

    • Slone, D., et al.: N Engl J Med 305(8):420-424, 1981.

    • Vessey, M.P.: Br J Fam Plann 6 (Supplement):1-12, 1980.

    • Russell-Briefel, R., et al.: Prev Med 5:352-362, 1986.

    • Goldbaum, G., et al.: JAMA 258(10):1339-1342, 1987.

    • LaRosa, J.C.: J Reprod Med 31 (9):906-912, 1986.

    • Krauss, R.M., et al.: Am J Obstet Gynecol 145:446-452, 1983.

    • Wahl, P., et al.: N Engl J Med 308(15):862-867, 1983.

    • Wynn, V., et al.: Am J Obstet Gynecol 142(6):766-771, 1982.

    • Wynn V., et al.: J Reprod Med 31(9):892-897, 1986.

    • Inman, W.H., et al.: Br Med J 2(5599):193-199, 1968.

    • Maguire, M.G., et al.: Am J Epidemiol 110(2):188-195, 1979.

    • Petitti, D., et al.: JAMA 242(11):1150-1154, 1979.

    • Vessey, M.P., et al.: Br Med J 2(5599):199-205, 1968.

    • Vessey, M.P., et al.: Br Med J 2(5658):651-657, 1969.

    • Porter, J.B., et al.: Obstet Gynecol 59(3):299-302, 1982.

    • Vessey, M.P., et al.: J Biosoc Sci 8:373-427, 1976.

    • Mishell, D.R., et al.: Reproductive Endocrinology, Philadelphia, F.A. Davis Co., 1979.

    • Petitti, D.B., et al.: Lancet 2:234-236, 1978.

    • Collaborative Group for the Study of Stroke in Young Women: JAMA 231(7):718-722, 1975.

    • Inman, W.H., et al.: Br Med J 2:203-209, 1970.

    • Meade, T.W., et al.: Br Med J 280(6224):1157-1161, 1980.

    • Kay, C.R.: Am J Obstet Gynecol 142(6):762-765, 1982.

    • Gordon, T., et al.: Am J Med 62:707-714, 1977.

    • Royal College of General Practitioners' Oral Contraception Study: J Coll Gen Pract 33:75-82, 1983.

    • Ory, H.W.: Fam Plann Perspect 15(2):57-63, 1983.

    • Paul, C., et al.: Br Med J 293:723-725, 1986.

    • The Cancer and Steroid Hormone Study of the Centers for Disease Control: N Engl J Med 315(7):405-411, 1986.

    • Pike, M.C., et al.: Lancet 2:926-929, 1983.

    • Miller, D.R., et al.: Obstet Gynecol 68:863-868, 1986.

    • Olsson, H., et al.: Lancet 2:748-749, 1985.

    • McPherson, K., et al.: Br J Cancer 56:653-660, 1987.

    • Huggins, G.R., et al.: Fertil Steril 47(5):733-761, 1987.

    • McPherson, K., et al.: Br Med J 293:709-710, 1986.

    • Ory, H., et al.: Am J Obstet Gynecol 124(6):573-577, 1976.

    • Vessey, M.P., et al.: Lancet 2:930, 1983.

    • Brinton, L.A., et al.: Int J Cancer 38:339-344, 1986.

    • WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Br Med J 290:961-965, 1985.

    • Rooks, J.B., et al.: JAMA 242(7):644-648, 1979.

    • Bein, N.N., et al.: Br J Surg 64:433-435, 1977.

    • Klatskin, G.: Gastroenterology 73:386-394, 1977.

    • Henderson, B.E., et al.: Br J Cancer 48:437-440, 1983.

    • Neuberger, J., et al.: Br Med J 292:1355-1357, 1986.

    • Forman D., et al.: Br Med J 292:1357-1361, 1986.

    • Harlap, S., et al.: Obstet Gynecol 55(4):447-452, 1980.

    • Savolainen, E., et al.: Am J Obstet Gynecol 140(5):521-524, 1981.

    • Janerich, D.T., et al.: Am J Epidemiol 112(1):73-79, 1980.

    • Ferencz, C., et al.: Teratology 21:225-239, 1980.

    • Rothman, K.J., et al.: Am J Epidemiol 109(4):433-439, 1979.

    • Boston Collaborative Drug Surveillance Program: Lancet 1:1399-1404, 1973.

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

    • Rome Group for the Epidemiology and Prevention of Cholelithiasis: Am J Epidemiol 119(5):796-805, 1984.

    • Strom, B.L., et al.: Clin Pharmacol Ther 39(3):335-341, 1986.

    • Perlman, J.A., et al.: J Chronic Dis 38(10):857-864, 1985.

    • Wynn, V., et al.: Lancet 1:1045-1049, 1979.

    • Wynn, V.: Progesterone and Progestin, New York, Raven Press, 1983.

    • Wynn, V., et al.: Lancet 2:720-723, 1966.

    • Fisch, I.R., et al.: JAMA 237(23):2499-2503, 1977.

    • Laragh, J.H.: Am J Obstet Gynecol 126(1):141-147, 1976.

    • Ramcharan, S., et al.: Pharmacology of Steroid Contraceptive Drugs, New York, Raven Press, 1977.

    • Stockley, I.: Pharm J 216:140-143, 1976.

    • Dickey, R.P.: Managing Contraceptive Pill Patients, Oklahoma, Creative Informatics Inc., 1984.

    • Porter J.B., Hunter J., Jick H., et al.: Obstet Gynecol 1985;66:1-4.

    • Porter J.B., Hershel J., Walker A.M.: Obstet Gynecol 1987;70:29-32.

    • Fertility and Maternal Health Drugs Advisory Committee, F.D.A., October, 1989.

    • Schlesselman J., Stadel B.V., Murray P., Lai S.: Breast cancer in relation to early use of oral contraceptives. JAMA 1988;259:1828-1833.

    • Hennekens C.H., Speizer F.E., Lipnick R.J., Rosner B., Bain C., Belanger C., Stampfer M.J., Willett W., Peto R.: A case-control study of oral contraceptive use and breast cancer. JNCI 1984;72:39-42.

    • Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose veins. J Coll Gen Pract 28:393-399, 1978.

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

  • Drug Information Provided by National Library of Medicine (NLM).
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