Patients Should Be Counseled That This Product Does Not Protect Against HIV Infection (AIDS)
And Other Sexually Transmitted Diseases.
Physical Examination And Follow-Up
It is good medical practice for all women to have annual history and physical examinations, including
women using oral contraceptives. The physical examination, however, may be deferred until after
initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The
physical examination should include special reference to blood pressure, breasts, abdomen and pelvic
organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or
recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy.
Women with a strong family history of breast cancer or who have breast nodules should be monitored
with particular care.
Women who are being treated for hyperlipidemia should be followed closely if they elect to use oral
contraceptives. Some progestogens may elevate LDL levels and may render the control of
hyperlipidemias more difficult.
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid
hormones may be poorly metabolized in patients with impaired liver function.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution,
and only with careful monitoring, in patients with conditions which might be aggravated by fluid
Women with a history of depression should be carefully observed and the drug discontinued if
depression recurs to a serious degree.
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by
Interactions With Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased
norepinephrine-induced platelet aggregability.
- Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as
measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake
is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
- Other binding proteins may be elevated in serum.
- Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and
corticoids; however, free or biologically active levels remain unchanged.
- Triglycerides may be increased.
- Glucose tolerance may be decreased.
- Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical
significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
See WARNINGS section.
Pregnancy Category X.
See CONTRAINDICATIONS and WARNINGS sections.
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, and a
few adverse effects on the child have been reported, including jaundice and breast enlargement. In
addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing
the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral
contraceptives but to use other forms of contraception until she has completely weaned her child.
Safety and efficacy of Aurovela 1.5/30 has been established in women of reproductive age. Safety and
efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16
years and older. Use of this product before menarche is not indicated.
Information For The Patient
See PATIENT INFORMATION.
8. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 1). New England Journal of
Medicine, 305:612-618, 1981.
9. Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 2). New England Journal of
Medicine, 305:672-677, 1981.
10. Adam, S.A., and M. Thorogood: Oral contraception and myocardial infarction revisited: The effects
of new preparations and prescribing patterns. Brit. J. Obstet. and Gynec., 88:838-845, 1981.
11. Mann, J.I., and W.H. Inman: Oral contraceptives and death from myocardial infarction. Brit. Med. J.,
2(5965): 245-248, 1975.
12. Mann, J.I., M.P. Vessey, M. Thorogood, and R. Doll: Myocardial infarction in young women with
special reference to oral contraceptive practice. Brit. Med. J., 2(5956):241-245, 1975.
13. Royal College of General Practitioners' Oral Contraception Study: Further analyses of mortality in
oral contraceptive users. Lancet, 1:541-546, 1981.
14. Slone, D., S. Shapiro, D.W. Kaufman, L. Rosenberg, O.S. Miettinen, and P.D. Stolley: Risk of
myocardial infarction in relation to current and discontinued use of oral contraceptives. N.E.J.M.,
15. Vessey, M.P.: Female hormones and vascular disease: An epidemiological overview. Brit. J. Fam.
Plann., 6:1-12, 1980.
16. Russell-Briefel, R.G., T.M. Ezzati, R. Fulwood, J.A. Perlman, and R.S. Murphy: Cardiovascular risk
status and oral contraceptive use, United States, 1976-80. Preventive Medicine, 15:352-362, 1986.
17. Goldbaum, G.M., J.S. Kendrick, G.C. Hogelin, and E.M. Gentry: The relative impact of smoking and
oral contraceptive use on women in the United States. J.A.M.A., 258:1339-1342, 1987.
18. Layde, P.M., and V. Beral: Further analyses of mortality in oral contraceptive users: Royal College
General Practitioners' Oral Contraception Study. (Table 5) Lancet, 1:541-546, 1981.
19. Knopp, R.H.: Arteriosclerosis risk: The roles of oral contraceptives and postmenopausal estrogens.
J. of Reprod. Med., 31(9)(Supplement): 913-921, 1986.
20. Krauss, R.M., S. Roy, D.R. Mishell, J. Casagrande, and M.C. Pike: Effects of two low-dose oral
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subclasses. Am. J. Obstet. Gyn., 145:446-452, 1983.
21. Wahl, P., C. Walden, R. Knopp, J. Hoover, R. Wallace, G. Heiss, and B. Rifkind: Effect of
estrogen/progestin potency on lipid/lipoprotein cholesterol. N.E.J.M., 308:862-867, 1983.
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23. Wynn, V., and I. Godsland: Effects of oral contraceptives on carbohydrate metabolism. J. Reprod.
Medicine, 31 (9)(Supplement): 892-897, 1986.
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26. Maguire, M.G., J. Tonascia, P.E. Sartwell, P.D. Stolley, and M.S. Tockman: Increased risk of
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27. Pettiti, D.B., J. Wingerd, F. Pellegrin, and S. Ramacharan: Risk of vascular disease in women:
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thromboembolic disease. Brit. Med. J., 2(5599): 199-205, 1968.
29. Vessey, M.P., and R. Doll: Investigation of relation between use of oral contraceptives and
thromboembolic disease: A further report. Brit. Med. J., 2(5658): 651-657, 1969.
30. Porter, J.B., J.R. Hunter, D.A. Danielson, H. Jick, and A. Stergachis: Oral contraceptives and nonfatal
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31. Vessey, M., R. Doll, R. Peto, B. Johnson, and P. Wiggins: A long-term follow-up study of women
using different methods of contraception: An interim report. J. Biosocial. Sci., 8:375-427, 1976.
32. Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose
veins. J. of Royal College of General Practitioners, 28:393-399, 1978.
33. Collaborative Group for the study of stroke in young women: Oral contraception and increased risk
of cerebral ischemia or thrombosis. N.E.J.M., 288:871-878, 1973.
34. Petitti, D.B., and J. Wingerd: Use of oral contraceptives, cigarette smoking, and risk of subarachnoid
hemorrhage. Lancet, 2:234-236, 1978.
35. Inman, W.H.: Oral contraceptives and fatal subarachnoid hemorrhage. Brit. Med. J., 2(6203): 1468-
36. Collaborative Group for the study of stroke in young women: Oral contraceptives and stroke in
young women: Associated risk factors. J.A.M.A., 231:718-722, 1975.
37. Inman, W.H., M.P. Vessey, B. Westerholm, and A. Engelund: Thromboembolic disease and the
steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs. Brit. Med. J., 2:203-209, 1970.
38. Meade, T.W., G. Greenberg, and S.G. Thompson: Progestogens and cardiovascular reactions
associated with oral contraceptives and a comparison of the safety of 50 and 35 mcg oestrogen
preparations. Brit. Med. J., 280(6224): 1157-1161, 1980.
39. Kay, C.R.: Progestogens and arterial disease: Evidence from the Royal College of General
Practitioners' study. Amer. J. Obstet. Gyn., 142:762-765, 1982.
40. Royal College of General Practitioners: Incidence of arterial disease among oral contraceptive
users. J. Coll. Gen. Pract., 33:75-82, 1983.
41. Ory, H.W: Mortality associated with fertility and fertility control:1983. Family Planning
Perspectives, 15:50-56, 1983.
42. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute
of Child Health and Human Development: Oral-contraceptive use and the risk of breast cancer.
N.E.J.M., 315: 405-411, 1986.
43. Pike, M.C., B.E. Henderson, M.D. Krailo, A. Duke, and S. Roy: Breast cancer in young women and
use of oral contraceptives: Possible modifying effect of formulation and age at use. Lancet, 2:926-
44. Paul, C., D.G. Skegg, G.F.S. Spears, and J.M. Kaldor: Oral contraceptives and breast cancer: A
national study. Brit. Med. J., 293:723-725, 1986.
45. Miller, D.R., L. Rosenberg, D.W. Kaufman, D. Schottenfeld, P.D. Stolley, and S. Shapiro: Breast
cancer risk in relation to early oral contraceptive use. Obstet. Gynec., 68:863-868, 1986.
46. Olson, H., K.L. Olson, T.R. Moller, J. Ranstam, P. Holm: Oral contraceptive use and breast cancer in
young women in Sweden (letter). Lancet, 2:748-749, 1985.
47. McPherson, K., M. Vessey, A. Neil, R. Doll, L. Jones, and M. Roberts: Early contraceptive use and
breast cancer: Results of another case-control study. Brit. J. Cancer, 56: 653-660, 1987.
48. Huggins, G.R., and P.F. Zucker: Oral contraceptives and neoplasia: 1987 update. Fertil. Steril., 47:733-761, 1987.
49. McPherson, K., and J.O. Drife: The pill and breast cancer: Why the uncertainty? Brit. Med. J., 293:709-710, 1986.
51. Ory, H., Z. Naib, S.B. Conger, R.A. Hatcher, and C.W. Tyler: Contraceptive choice and prevalence
of cervical dysplasia and carcinoma in situ. Am. J. Obstet. Gynec., 124:573-577, 1976.
52. Vessey, M.P., M. Lawless, K. McPherson, D. Yeates: Neoplasia of the cervix uteri and
contraception: A possible adverse effect of the pill. Lancet, 2:930, 1983.
53. Brinton, L.A., G.R. Huggins, H.F. Lehman, K. Malli, D.A. Savitz, E. Trapido, J. Rosenthal, and R.
Hoover: Long-term use of oral contraceptives and risk of invasive cervical cancer. Int. J. Cancer, 38:339-344, 1986.
54. WHO Collaborative Study of Neoplasia and Steroid Contraceptives: Invasive cervical cancer and
combined oral contraceptives. Brit. Med. J., 290:961-965, 1985.
55. Rooks, J.B., H.W. Ory, K.G. Ishak, L.T. Strauss, J.R. Greenspan, A.P. Hill, and C.W. Tyler:
Epidemiology of hepatocellular adenoma: The role of oral contraceptive use. J.A.M.A., 242:644-
56. Bein, N.N., and H.S. Goldsmith: Recurrent massive hemorrhage from benign hepatic tumors
secondary to oral contraceptives. Brit. J. Surg., 64:433-435, 1977.
57. Klatskin, G.: Hepatic tumors: Possible relationship to use of oral contraceptives. Gastroenterology, 73:386-394, 1977.
58. Henderson, B.E., S. Preston-Martin, H.A. Edmondson, R.L. Peters, and M.C. Pike: Hepatocellular
carcinoma and oral contraceptives. Brit. J. Cancer, 48:437-440, 1983.
59. Neuberger, J., D. Forman, R. Doll, and R. Williams: Oral contraceptives and hepatocellular
carcinoma. Brit. Med. J., 292:1355-1357, 1986.
60. Forman, D., T.J. Vincent, and R. Doll: Cancer of the liver and oral contraceptives. Brit. Med. J.,
61. Harlap, S., and J. Eldor: Births following oral contraceptive failures. Obstet. Gynec., 55:447-452,
62. Savolainen, E., E. Saksela, and L. Saxen: Teratogenic hazards of oral contraceptives analyzed in a
national malformation register. Amer. J. Obstet. Gynec., 140:521-524, 1981.
63. Janerich, D.T., J.M. Piper, and D.M. Glebatis: Oral contraceptives and birth defects. Am. J.
Epidemiology, 112:73-79, 1980.
64. Ferencz, C., G.M. Matanoski, P.D. Wilson, J.D. Rubin, C.A. Neill, and R. Gutberlet: Maternal
hormone therapy and congenital heart disease. Teratology, 21:225-239, 1980.
65. Rothman, K.J., D.C. Fyler, A. Goldbatt, and M.B. Kreidberg: Exogenous hormones and other drug
exposures of children with congenital heart disease. Am. J. Epidemiology, 109:433-439, 1979.
66. Boston Collaborative Drug Surveillance Program: Oral contraceptives and venous thromboembolic
disease, surgically confirmed gallbladder disease, and breast tumors. Lancet, 1:1399-1404, 1973.
67. Royal College of General Practitioners: Oral Contraceptives and Health. New York, Pittman, 1974,
68. Layde, P.M., M.P. Vessey, and D. Yeates: Risk of gallbladder disease: A cohort study of young
women attending family planning clinics. J. of Epidemiol. and Comm. Health, 36: 274-278, 1982.
69. Rome Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO): Prevalence of
gallstone disease in an Italian adult female population. Am. J. Epidemiol., 119:796-805, 1984.
70. Strom, B.L., R.T. Tamragouri, M.L. Morse, E.L. Lazar, S.L. West, P. D. Stolley, and J.K. Jones:
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71. Wynn, V., P.W. Adams, I.F. Godsland, J. Melrose, R. Niththyananthan, N.W. Oakley, and A. Seedj:
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lipid metabolism. Lancet, 1:1045-1049, 1979.
72. Wynn, V.: Effect of progesterone and progestins on carbohydrate metabolism. In Progesterone and
Progestin. Edited by C.W. Bardin, E. Milgrom, P. Mauvis-Jarvis. New York, Raven Press, pp. 395-
73. Perlman, J.A., R. G. Roussell-Briefel, T.M. Ezzati, and G. Lieberknecht: Oral glucose tolerance and
the potency of oral contraceptive progestogens. J. Chronic Dis., 38:857-864, 1985.
74. 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,
75. Fisch, I.R., and J. Frank: Oral contraceptives and blood pressure. J.A.M.A., 237:2499-2503, 1977.
76. Laragh, A.J.: Oral contraceptive induced hypertension: Nine years later. Amer. J. Obstet. Gynecol.,
77. Ramcharan, S., E. Peritz, F.A. Pellegrin, and W.T. Williams: Incidence of hypertension in the Walnut
Creek Contraceptive Drug Study cohort. In Pharmacology of Steroid Contraceptive Drugs. Edited
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Mario Negri Institute for Pharmacological Research, Milan.)
85. Miller, D.R., L. Rosenberg, D.W. Kaufman, P. Stolley, M.E. Warshauer, and S. Shapiro: Breast
cancer before age 45 and oral contraceptive use: new findings. Am. J. Epidemiol., 129:269-280,
86. Kay, C.R., and P.C. Hannaford: Breast cancer and the pill: a further report from the Royal College of
General Practitioners Oral Contraception Study. Br. J. Cancer, 58:675-680, 1988.
87. Stadel, B.V., S. Lai, J.J. Schlesselman, and P. Murray: Oral contraceptives and premenopausal breast
cancer in nulliparous women. Contraception, 38:287-299, 1988.
88. UK National Case-Control Study Group: Oral contraceptive use and breast cancer risk in young
women. Lancet, 973-982, 1989.
89. Romieu, I., W.C. Willett, G.A. Colditz, M.J. Stampfer, B. Rosner, C.H. Hennekens, and F.E. Speizer:
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