INDICATIONS
AND USES
ESTRATEST® and ESTRATEST® H.S. are indicated
in the treatment of:
Moderate to severe vasomotor symptoms associated with
the menopause in those patients not improved by estrogens
alone. (There is no evidence that estrogens are effective
for nervous symptoms or depression without associated
vasomotor symptoms, and they should not be used to treat
such conditions.)
ESTRATEST® AND ESTRATEST® H.S. HAVE NOT BEEN SHOWN
TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS
USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING
).
DOSAGE AND ADMINISTRATION
1. Given cyclically for short-term use only:
For treatment of moderate to severe vasomotor symptoms
associated with the menopause in patients not improved
by estrogen alone.
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., three weeks on
and one week off).
Attempts to discontinue or taper medication should be
made at three to six month intervals.
Usual Dosage Range: 1 tablet of ESTRATEST
or 1 to 2 tablets of ESTRATEST H.S. daily as recommended
by the physician.
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.
HOW SUPPLIED
ESTRATEST® (Imprinted "SOLVAY 1026") in
bottles of 100 NDC 0032-1026-01 and 1000 NDC 0032-1026-10.
ESTRATEST® (Dark green, capsule shaped, sugar-coated
oral tablets) contains: 1.25 mg of Esterified Estrogens,
USP and 2.5 mg of Methyltestosterone, USP.
ESTRATEST® H.S. (Imprinted "SOLVAY 1023")
in bottles of 100 NDC 0032-1023-01.
ESTRATEST® H.S. "Half-Strength" (Light
green, capsule shaped, sugar-coated oral tablets) contains:
0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone,
USP.
ESTRATEST® H.S. a combination of Esterified Estrogens
and Methyltestosterone. Each capsule-shaped light green,
sugar coated Tablet contains: 0.625 mg of Esterified Estrogens,
USP and 1.25 mg of Methyltestosterone, USP.
ESTRATEST® a combination of Esterified Estrogens
and Methyltestosterone. Each capsule-shaped dark green
sugar-coated Tablet contains: 1.25 mg of Esterified Estrogens,
USP and 2.5 mg of Methyltestosterone, USP.
Store at controlled room temperature, 15°-30°C
(59°-86°F).
Rx only
REFERENCES
1. Ziel, H.K., et al.: N. Engl. J. Med. 293 :1167-1170,
1975.
2. Smith, D.C., et al.: N. Engl. J. Med. 293 :1164-1167,
1975.
3. Mack, T.M., et al.: N. Engl. J. Med. 294 :1262-1267,
1976.
4. Weiss, N.S., et al.: N. Engl. J. Med. 294 :1259-1262,
1976.
5. Herbst, A.L., et al.: N. Engl. J. Med. 284 :878-881,
1971.
6. Greenwald, P., et al.: N. Engl. J. Med. 285 :390-392,
1971.
7. Lanier, A., et al.: Mayo Clin. Proc. 48 :793-799,
1973.
8. Herbst, A., et al.: Obstet. Gynecol. 40 :287-298,
1972.
9. Herbst, A., et al.: Am. J. Obstet. Gynecol. 118 :607-615,
1974.
10. Herbst, A., et al.: N. Engl. J. Med. 292 :334-339,
1975.
11. Stafl, A., et al.: Obstet. Gynecol. 43 :118-128,
1974.
12. Sherman, A.I., et al.: Obstet. Gynecol. 44 :531-545,
1974.
13. Gal, I., et al.: Nature 216 :83, 1967.
14. Levy, E.P., et al.: Lancet 1 :611, 1973.
15. Nora, J., et al.: Lancet 1 :941-942, 1973.
16. Janerich, D.T., et al.: N. Engl. J. Med. 291 :697-700,
1974.
17. Estrogens for Oral or Parenteral Use: Federal Register
40 :8212, 1975.
18. Boston Collaborative Drug Surveillance Program: N.
Engl. J. Med. 290 :15-19, 1974.
18a. Hoover, R., et al.: N. Engl. J. Med. 295 :401-405,
1976.
19. Boston Collaborative Drug Surveillance Program: Lancet
1 :1399-1404, 1973.
20. Daniel, D.G., et al.: Lancet 2 :287-289, 1967.
21. The Veterans Administration Cooperative Urological
Research Group: J. Urol. 98 :516-522, 1967.
22. Bailar, J. C.: Lancet 2 :560, 1967.
23. Blackard, C., et al.: Cancer 26 :249-256, 1970.
24. Royal College of General Practitioners: J.R. Coll,
Gen. Pract. 13 :267-279, 1967.
25. Inman, W.H.W., et al.: Br. Med. J. 2 :193-199, 1968.
26. Vessey, M.P., et al.: Br. Med. J. 2 :651-657, 1969.
27. Sartwell, P.E., et al.: Am. J. Epidemiol, 90 :365-380,
1969.
28. Collaborative Group for the Study of Stroke in Young
Women: N. Engl. J. Med. 288 :871-878, 1973.
29. Collaborative Group for the Study of Stroke in Young
Women: J.A.M.A. 231 :718-722, 1975.
30. Mann, J.I., et al.: Br. Med. J. 2 :245-248, 1975.
31. Mann, J.I., et al.: Br. Med. J. 2 :241-245, 1975.
32. Inman, W.H.W., et al.: Br. Med. J. 2 :203-209, 1970.
33. Stolley, P.D., et al.: Am. J. Epidemiol, 102 :197-208,
1975.
34. Vessey, M.P., et al.: Br. Med. J. 3 :123-126, 1970.
35. Greene, G.R., et al.: Am. J. Public Health 62 :680-685,
1972.
36. Rosenberg, L., et al.: N. Engl. J. Med. 294 :1256-1259,
1976.
37. Coronary Drug Project Research Group: J.A.M.A. 214
:1303-1313, 1970.
38. Baum, J., et al.: Lancet 2 :926-928, 1973.
39. Mays, E.T., et al.: J.A.M.A. 235 :730-732, 1976.
40. Edmondson, H.A., et al.: N. Engl. J. Med. 294 :470-472,
1976.
41. Pfeffer, R.I., et al.: Am. J. Epidemiol, 103 :445-456,
1976.
Rx only
Solvay
Pharmaceuticals, Inc.
Marietta, GA 30062
© 1998 Solvay Pharmaceuticals, Inc.
|
|
