Menest (esterified estrogens tablets) is indicated in the treatment of:

1. Moderate to severe vasomotor symptoms associated with the menopause. (There is no evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause, and they should not be used to treat these conditions.)
2. Atrophic vaginitis.
3. Kraurosis vulvae.
4. Female hypogonadism.
5. Female castration.
6. Primary ovarian failure.
7. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
8. Prostatic carcinoma palliative therapy of advanced disease.

MENEST (esterified estrogens tablets) HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).

1. Given cyclically for short term use only:
   For treatment of moderate to severe vasomotor symptoms, 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 promptly as possible.
   Administration should be cyclic (e.g., 3 weeks on and 1 week off).
   Attempts to discontinue or taper medication should be made at 3 to 6 month intervals.
   USUAL DOSAGE RANGES:
   Vasomotor symptoms 1.25 mg daily. If the patient has not menstruated within the last 2 months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic administration is started on day 5 of bleeding.
   Atrophic vaginitis and kraurosis vulvae 0.3 mg to 1.25 mg or more daily, depending upon the tissue response of the individual patient. Administer cyclically.
2. Given cyclically:   Female hypogonadism; female castration; primary ovarian failure.
   USUAL DOSAGE RANGES:
   Female hypogonadism 2.5 to 7.5 mg daily, in divided doses for 20 days, followed by a rest period of 10 days' duration. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on responsiveness of the endometrium.
   If bleeding occurs before the end of the 10 day period, begin a 20 day estrogen-progestin cyclic regimen with Menest (esterified estrogens tablets), 2.5 to 7.5 mg daily in divided doses, for 20 days. During the last 5 days of estrogen therapy, give an oral progestin. If bleeding occurs before this regimen is concluded, therapy is discontinued and may be resumed on the fifth day of bleeding.
   Female castration and primary ovarian failure 1.25 mg daily, cyclically. Adjust dosage upward or downward according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
3. Given chronically:   Inoperable progressing prostatic cancer 1.25 to 2.5 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.
   Inoperable progressing breast cancer in appropriately selected men and postmenopausal women. (See

   INDICATIONS

   AND USAGE) Suggested dosage is 10 mg three times daily for a period of at least 3 months.
   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.

Tablets:

0.3 mg yellow, film-coated oblong tablet imprinted with M72 100's: NDC 61570-072-01

0.625 mg orange, film-coated oblong tablet imprinted with M73 100's: NDC 61570-073-01

1.25 mg green, film-coated oblong tablet imprinted with M74 100's: NDC 61570-074-01

2.5 mg pink, film-coated oblong tablet imprinted with M75 50's: NDC 61570-075-50

PHYSICIAN REFERENCES

1. Ziel HK, Finkel WD: Increased Risk of Endometrial Carcinoma Among Users of Conjugated Estrogens, New England Journal of Medicine 293:1167-1170, 1975.
2. Smith DC, Prentic R, Thompson DJ, Hermann WL: Association of Exogenous Estrogen and Endometrial Carcinoma, New England Journal of Medicine 293:1164-1167, 1975.
3. Mack TM, Pike MC, Henderson BE, et al: Estrogens and Endometrial Cancer in a Retirement Community, New England Journal of Medicine 294:1262-1267, 1976.
4. Weiss NS, Szekely DR, Austin DF: Increasing Incidence of Endometrial Cancer in the United States, New England Journal of Medicine 294:1259-1262, 1976.
5. Herbst AL, Ulfelder H, Poskanzer DC: Adenocarcinoma of Vagina, New England Journal of Medicine 284:878-881, 1971.
6. Greenwald P, Barlow J, Nasca P, Burnett W: Vaginal Cancer After Maternal Treatment with Synthetic Estrogens, New England Journal of Medicine 285:390-392, 1971.
7. Lanier A, Noller K, Decker D, et al: Cancer and Stilbestrol. A Follow-up of 1719 Persons Exposed to Estrogens in Utero and Born 1943-1959, Mayo Clinic Proceedings 48:793-799, 1973.
8. Herbst A, Kurman R, Scully R: Vaginal and Cervical Abnormalities After Exposure to Stilbestrol In Utero, Obstetrics and Gynecology 40:287-298, 1972.
9. Herbst A, Robboy S, Macdonald G, Scully R: The Effects of Local Progesterone on Stilbestrol-Associated Vaginal Adenosis, American Journal of Obstetrics and Gynecology 118:607-615, 1974.
10. Herbst A, Poskanzer D, Robboy S, et al: Prenatal Exposure to Stilbestrol, A Prospective Comparison of Exposed Female Offspring with Unexposed Controls, New England Journal of Medicine 292:334-339, 1975.
11. Stafl A, Mattingly R, Foley D, Fetherston W: Clinical Diagnosis of Vaginal Adenosis, Obstetrics and Gynecology 43:118-128, 1974.
12. Sherman AI, Goldrath M, Berlin A, et al: Cervical-Vaginal Adenosis After In Utero Exposure to Synthetic Estrogens, Obstetrics and Gynecology 44:531-545, 1974.
13. Gal I, Kirman B, Stern J: Hormone Pregnancy Tests and Congenital Malformation, Nature 216:83, 1967.
14. Levy EP, Cohen A, Fraser FC: Hormone Treatment During Pregnancy and Congenital Heart Defects, Lancet 1:611, 1973.
15. Nora J, Nora A: Birth Defects and Oral Contraceptives, Lancet 1:941-942, 1973.
16. Janerich DT, Piper JM, Glebatis, DM: 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 40:8212, 1975.
18. Boston Collaborative Drug Surveillance Program: Surgically Confirmed Gall Bladder Disease, Venous Thromboembolism and Breast Tumors in Relations to Post-Menopausal Estrogen Therapy, New England Journal of Medicine 290:15-19, 1974.
    18a.Hoover R, Gray LA Sr, Cole P, MacMahon B: Menopausal Estrogens and Breast Cancer, New England Journal of Medicine 295:401-405, 1976.
19. Boston Collaborative Drug Surveillance Program: Oral Contraceptives and Venous Thromboembolic Disease, Surgically Confirmed Gall Bladder Disease, and Breast Tumors, Lancet 1:1399-1404, 1973.
20. Daniel DG, Campbell H, Turnbull AC: Puerperal Thromboembolism and Suppression of Lactation, Lancet 2:287-289, 1967.
21. The Veterans Administration Cooperative Urological Research Group: Carcinoma of the Prostate: Treatment Comparisons, Journal of Urology 98:516-522, 1967.
22. Bailar JC: Thromboembolism and Oestrogen Therapy, Lancet 2:560, 1967.
23. Blackard C, Doe R, Mellinger G, Byar D: Incidence of Cardiovascular Disease and Death in Patients Receiving Diethylstilbestrol for Carcinoma of the Prostate, Cancer 26:249-256, 1970.
24. Royal College of General Practitioners: Oral Contraception and Thromboembolic Disease, Journal of the Royal College of General Practitioners 13:267-279, 1967.
25. Inman WHW, Vessey MP: Investigation of Deaths from Pulmonary, Coronary and Cerebral Thrombosis and Embolism in Women of Child-Bearing Age, British Medical Journal 2:193-199, 1968.
26. Vessey MP, Doll R: Investigation of Relation Between Use of Oral Contraceptives and Thromboembolic Disease. A Further Report, British Medical Journal 2:651-657, 1969.
27. Sartwell PE, Masi AT, Arthes FG, et al: Thromboembolism and Oral Contraceptives: An Epidemiological Case Control Study, American Journal of Epidemiology 90:365-380, 1969.
28. Collaborative Group for the Study of Stroke in Young Women: Oral Contraception and Increased Risk of Cerebral Ischemia or Thrombosis, New England Journal of Medicine 288:871-878, 1973.
29. Collaborative Group for the Study of Stroke 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 JI, Inman WHW: Oral Contraceptives and Death from Myocardial Infarction, British Medical Journal 2:245-248, 1975.
31. Mann JI, Vessey MP, Thorogood M, Doll R: Myocardial Infarction in Young Women with Special Reference to Oral Contraceptive Practice, British Medical Journal 2:241-245, 1975.
32. Inman WHW, Vessey VP, Westerholm B, Engelund A: Thromboembolic Disease and the Steroidal Content of Oral Contraceptives, British Medical Journal 2:203-209, 1970.
33. Stolley PD, Tonascia JA, Tockman MS, et al: Thrombosis with Low-Estrogen Oral Contraceptives, American Journal of Epidemiology 102:197-208, 1975.
34. Vessey MP, Doll R, Fairbairn AS, Glober G: Post-Operative Thromboembolism and the Use of the Oral Contraceptives, British Medical Journal 3:123-126, 1970.
35. Greene GR, Sartwell PE: Oral Contraceptive Use in Patients with Thromboembolism Following Surgery, Trauma or Infection, American Journal of Public Health 62:680-685, 1972.
36. Rosenberg L, Armstrong MB, Jick H: 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 Modification of Its Research Protocol, Journal of the American Medical Association 214:1303-1313, 1970.
38. Baum J, Holtz F, Bookstein JJ, Klein EW: Possible Association Between Benign Hepatomas and Oral Contraceptives, Lancet 2:926-928, 1973.
39. Mays ET, Christopherson WM, Mahr MM, Williams HC: Hepatic Changes in Young Women Ingesting Contraceptive Steroids, Hepatic Hemorrhage and Primary Hepatic Tumors, Journal of the American Medical Association 235:730-782, 1976.
40. Edmondson HA, Henderson B, Benton B: Liver Cell Adenomas Associated with the Use of Oral Contraceptives, New England Journal of Medicine 294:470-472, 1976.
41. Pfeffer RI, Van Den Noort S: Estrogen Use and Stroke Risk in Postmenopausal Women, American Journal of Epidemiology 103:445-456, 1976.

Rx only.

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: King Pharmaceuticals, Inc., Bristol, TN 37620

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