ORTHO Dienestrol Cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae.

ORTHO DIENESTROL CREAM HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE DESCRIPTION: BOXED WARNING)

Given cyclically for short term use only:

For the treatment of atrophic vaginitis, or kraurosis vulvae associated with the menopause.

The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptlyas possible.

Attempts to discontinue or taper medication should be made at 3 to 6 month intervals.

The usual dosage range is one or two applicatorsful per day for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of one applicatorful, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Available in 2.75 oz. (78g) tubes with or without ORTHO* Measured Dose Applicator, 5g.

With applicator: NDC 0062-5450-77
Without applicator: NDC 0062-5450-00

Store at controlled room temperature.

REFERENCES

1. Ziel, H. K. and W. D. Finkle, "Increased Risk of Endometrial Carcinoma Among Users of Conjugated Estrogens," New England Journal of Medicine, 293: 1167- 1170, 1975.
2. Smith, D. C., R. Prentic, D. J. Thompson, and W. L. Hermann, "Association of Exogenous Estrogen Carcinoma," New England Journal ofMedicine, 293: 1164- 1167, 1975.
3. Mack, T. M., M. C. Pike, B. E. Henderson, R. I. Pfeffer, V. R. Gerkins, M. Arthur, and S. E. Brown, "Estrogens and Endometrial Cancer in a Retirement Community," New England Journal of Medicine, 294: 1267- 1287, 1976.
4. Weiss, N. S., D. R. Szekely and D. F. Austin, "Increasing Incidence of Endometrial Cancer in the United States," New England Journal ofMedicine, 294: 1259- 1262, 1976.
5. Herbst, A. L., H. Ulfelder and D. C. Poskanzer, "Adenocarcinoma of Vagina," New England Journal of Medicine, 284: 878- 881, 1971.
6. Greenwald, P., J. Barlow, P. Nasca, and W. Burnett, "Vaginal Cancer after Maternal Treatment with Synthetic Estrogens," New England Journal ofMedicine, 285: 390- 392, 1971.
7. Lanier, A., K. Noller, D. Decker, L. Elveback, and L. Kurland, "Cancer and Stilbestrol. A Follow- up if 1719 Persons Exposed to Estrogens In Utero and Born 1943- 1959." Mayo Clinic Proceedings, 48: 793- 799, 1973.
8. Herbst, A., R. Kurman and R. Scully, "Vaginal and Cervical AbnormalitiesAfter Exposureto Stilbestrol In Utero," Obstetrics and Gynecology, 40: 287- 298, 1972.
9. Herbst, A., S. Robboy, G. Macdonald, and R. Scully, "The Effects of Local Progesterone on Stilbestrol- Associated Vaginal Adenosis." American Journal of Obstetrics and Gynecology, 118: 607- 615, 1974.
10. Herbst, A., D. Poskanzer, S. Robboy, L. Friedlander, and R. Scully, "Prenatal Exposure to Stilbestrol, A Prospective Comparison of Exposed Female Offspring with Unexposed Controls," New England Journal of Medicine, 292: 334- 339, 1975.
11. Staffi, A., R. Mattingly, D. Foley, and W. Fetherston, "Clinical Diagnosis of Vaginal Adenosis," Obstetrics and Gynecology, 43: 118- 128, 1974.
12. Sherman, A. l., M. Goidrath, A. Berlin, V. Vakhariya, F. Banooni, W. Michaels, P. Goodman, S. Brown, "Cervical- VaginalAdenosis After/ n Utero Exposureto Synthetic Estrogens," Obstetrics and Gynecology, 44: 531- 545, 1974.
13. Gal, I., B. Kirman, and J. Stern, "Hormone Pregnancy Tests and Congenital Malformation," Nature, 216: 83, 1967.
14. Levy, E. P., A. Cohen, and F. C. Fraser, "Hormone Treatment During Pregnancy and Congenital Heart Defects," Lancet, 1: 611, 1973.
15. Nora, J. and A. Nora, "Birth Defects and Oral Contraceptives," Lancet, 1: 941 -942, 1973.
16. Janerich, D. T., J. M. Piper, and D. M. Glebatis, "Oral Contraceptives and Congenital Limb- Reduction Defects," New England Journal of Medicine, 291: 697- 700, 1974.
17. "Estrogens for Oral or Parenteral Use," Federal Register; 40: 821 2, 1975.
18. Boston Collaborative Drug SurveillanceProgram "Surgically Confirmed Gall Bladder Disease, Venous Thromboembolism and Breast Tumors in Relation to Post- Menopausal Estrogen Therapy," New England Journal of Medicine, 290: 15- 19, 1974. 18a. Hoover, R., L. A. Gray, Sr., P Cole, and B. MacMahon, "Menopausal Estrogens and Breast Cancer," New England Journal of Medicine, 295: 401- 405, 1976.
19. Contraceptives andVenous Thromboembolic Disease, Surgically Boston Collaborative Drug Surveillance Program, "Oral Confirmed Gall Bladder Disease, and Breast Tumors," Lancet, 1: 1399- 1404, 1973. Thromboembolism and Suppression of Lactation," Lancet,
20. Daniel, D. G., H. Campbell, and A. C. Turnbull, "Puerperal 2: 287- 289, 1967.
21. Journal of Urology, Group, "Carcinoma of the Prostate: Treatment Comparisons," The Veterans Administration Cooperative Urological Research 98: 516- 522, 1967.
22. Bailar, J. C., "Thromboembolism and Oestrogen Therapy," Lancet, 2: 560, 1967.
23. Blackard, C., R. Doe, G. Mellinger, and D. Byar, "Incidence of Cardiovascular Disease and Death in Patients Receiving Diethylstilbestrol for Carcinoma of the Prostate," Cancer, 26: 249- 256, 1970.
24. Royal College ofGeneral Practitioners, "Oral Contraception and Thromboembolic Disease," Journalofthe Royal College of General Practitioners, 13: 267- 279, 1967.
25. Inman, W. H. W. and M. P. Vessey, "Investigation ofDeaths from Pulmonary, Coronary, and Cerebral Thrombosis and Embolism in Women ofChild- BearingAge," British MedicalJournal, 2: 193- 199, 1968.
26. Vessey, M. P. and R. Doll, "Investigation of Relation Between Use of Oral Contraceptives and Thromboembolic Disease, A Further Report," British Medical Journal, 2: 651- 657, 1969.
27. Sartwell, P. E., A. T. Masi, EG. Arthes, G. R. Greene, and H. E. Smith, "Thromboembolism and Oral Contraceptives: An Epidemiological Case Control Study," American Journal of Epidemiology, 90: 365- 380, 1969.
28. Collaborative Group forthe Study ofStroke in Young Women, "Oral Contraception and Increased Risk of Cerebral lschemia or Thrombosis," New England Journal of Medicine, 288: 871- 878, 1973.
29. Collaborative Group forthe Study ofStroke in Young Women, "Oral Contraceptives and Stroke in Young Women: Associated Risk Factors," Journal of the American Medical Association, 231: 718- 722, 1975.
30. Mann, J. l. and W. H. Inman, "Oral Contraceptives and Death from Myocardial Infarction," British MedicalJournal, 2: 245- 248, 1975.
31. Mann, J. l., M. P. Vessey, M. Thorogood, and R. Doll, "Myocardial Infarction in Young Womenwith Special Reference to Oral Contraceptive Practice," British MedicalJournal, 2: 241- 245, 1975.
32. lnman, W. H. W., V. P. Vessey, B. Westerholm, and A. Engelund, "Thromboembolic Disease and the Steroidal Content of Oral Contraceptives," British MedicalJournal, 2: 203- 209, 1970.
33. Stolley, RD., J. A. Tonascia, M. S. Tockman, RE. Sartwell, A. H. Rutledge, and M. P. Jacobs, "Thrombosiswith Low- Estrogen Oral Contraceptives," American Journal of Epidemiology, 102: 197- 208, 1975.
34. Vessey, M. P., R. Doll, A. S. Fairbairn, and G. Glober, "Post-Operative Thromboembolism and the Use of the Oral Contraceptives," British Medical Journal, 3: 123- 126, 1970.
35. Greene, G. R. and RE. Sartwell, "Oral Contraceptive Use in Patients with Thromboembolism Following Surgery, Trauma or Infection," AmericanJournal ofPublic Health, 62: 680- 685, 1972.
36. Rosenberg, L., M. B. Armstrong and H. Jick, "Myocardial Infarction and Estrogen Therapy in Postmenopausal Women," New England Journal of Medicine, 294: 1256- 1259, 1976.
37. Coronary Drug Project Research Group, "The Coronary Drug Project: Initial Findings Leading to Modifications of Its Research Protocol," Journal of the American Medical Association, 214: 1303- 1313, 1970.
38. Baum, J., F. Holtz, J. J. Bookstein, and E. W. Klein, "Possible Association between Benign Hepatomas and Oral Contra-ceptives," Lancet, 2: 926- 928, 1973.
39. Mays, E. T., W. M. Christopherson, M. M. Mahr, and H. C. Williams, "Hepatic Changes in Young Women Ingesting Contraceptive Steroids, Hepatic Hemorrhage and Primary 235: 730- 782, 1976. Hepatic Tumors," Journal of the American MedicalAssociation,
40. Edmondson, H. A., B. Henderson, and B. Benton, "Liver Cell Adenomas Associatedwith the Use ofOral Contraceptives," New England Journal of Medicine, 294: 470- 472, 1976.
41. Pfeffer, R. l. and S. Van Den Noore, "Estrogen Use andStroke Risk in Postmenopausal Women," American Journal of Epidemiology, 103: 445- 456, 1976.

ORTHO-McNEIL
PHARMACEUTICAL, INC.
Raritan, New Jersey 08869

REVISED MARCH 1998

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