"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
- Patient Information:
Details with Side Effects
DEPO-Estradiol (estradiol cypionate injection) Injection is indicated in the treatment of:
- Moderate to severe vasomotor symptoms associated with the menopause.
- Hypoestrogenism due to hypogonadism.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
DEPO-Estradiol (estradiol cypionate injection) INJECTION IS FOR INTRAMUSCULAR USE ONLY.
When estrogen is prescribed for a woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary. (See Boxed Warnings and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
- Short-term cyclic use for treatment of moderate to severe vasomotor symptoms,
vulval and vaginal atrophy associated with the menopause, the lowest dose
and regimen that will control symptoms should be chosen and medication should
be discontinued as promptly as possible.
Attempts to discontinue or taper medication should be made at 3- to 6-month intervals. The usual dosage range is 1 to 5 mg injected every 3 to 4 weeks.
- For treatment of female hypoestrogenism due to hypogonadism 1.5 to 2 mg injected at monthly intervals.
DEPO-Estradiol (estradiol cypionate injection) Injection is available in the following concentration containing per mL:
5 mg estradiol cypionate; also 5.4 mg chlorobutanol anhydrous (chloral deriv.) added as preservative; in 913 mg cottonseed oil— in 5 mL vials, NDC 0009-0271-01.
WARNING: Chlorobutanol may be habit forming.
Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
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2. Smith DC, Prentice R, Thompson DJ, et al: Association of exogenous estrogen and endometrial carcinoma. N Engl J Med 293:1164–1167, 1975.
3. Mack TM, Pike MC, Henderson BE, et al: Estrogens and endometrial cancer in a retirement community. N Engl J Med 294:1262–1267, 1976.
4. Weiss NS, Szekely DR, Austin DF: Increasing incidence of endometrial cancer in the United States. N Engl J Med 294:1259–1262, 1976.
5. Herbst AL, Ulfelder H, Poskanzer DC: Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 284:878–881, 1971.
6. Greenwald P, Barlow JJ, Nasca PC, Burnett WS: Vaginal cancer after maternal treatment with synthetic estrogens. N Engl J Med 285:390–392, 1971.
7. Lanier AP, Noller KL, Decker DG, Elveback LR, Kurland LT: Cancer and stilbestrol. A follow-up of 1,719 persons exposed to estrogens in utero and born 1943–1959. Mayo Clin Proc 48:793–799, 1973.
8. Herbst AL, Kurman RJ, Scully RE: Vaginal and cervical abnormalities after exposure to stilbestrol in utero. Obstet Gynecol 40:287–298, 1972.
9. Herbst AL, Robboy SJ, Macdonald GJ, Scully RE: The effects of local progesterone on stilbestrol-associated vaginal adenosis. Am J Obstet Gynecol 118:607–615, 1974.
10. Herbst AL, Poskanzer DC, Robboy SJ, Friedlander L, Scully RE: Prenatal exposure to stilbestrol. A prospective comparison of exposed female offspring with unexposed control. N Engl J Med 292:334–339, 1975.
11. Stafl A, Mattingly RF, Foley DV, Fetherston WC: Clinical diagnosis of vaginal adenosis. Obstet Gynecol 43:118–128, 1974.
12. Sherman AL, Goldrath M, Berlin A, et al: Cervical-vaginal adenosis after in utero exposure to synthetic estrogens. Obstet Gynecol 44:531545, 1974.
13. Gall, Kirman B, Stern J: Hormonal 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 JJ, Nora AH: Birth defects and oral contraceptives. Lancet 1:941–942, 1973.
16. Janerich DT, Piper JM, Glebatis DM: Oral contraceptives and congenital limb-reduction defects. N Engl J Med 291:697–700, 1974.
17. Boston Collaborative Drug Surveillance Program: Surgically confirmed gall bladder disease, venous thromboembolism, and breast tumors in relation to post-menopausal estrogen therapy. N Engl J Med 290:15–19, 1974.
18. Hoover R, Gray LA, Cole P, MacMahon B: Menopausal estrogens and breast cancer. N Engl J Med 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. J Urol 98:516522, 1967.
22. Bailar JC: Thromboembolism and estrogen therapy. Lancet 2:560, 1967.
23. Blackard CE, Doe RP, Mellinger GT, Byar DP: 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. J R Coll Gen Pract 13:267–279, 1967.
25. Inman WHW, Vessey MP: Investigation of deaths from pulmonary, coronary, and cerebral thrombosis and embolism in women of childbearing age. Br Med J 2:193–199, 1968.
26. Vessey MP, Doll R: Investigation of relation between use of oral contraceptives and thromboembolic disease. A further report. Br Med J 2:651–657, 1969.
27. Sartwell PE, Masi AT, Arthes FG, et al: Thromboembolism and oral contraceptives: An epidemiologic case-control study. Am J Epidemiol 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. N Engl J Med 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. JAMA 231:718–722, 1975.
30. Mann JI, Inman WHW: Oral contraceptives and death from myocardial infarction. Br Med J 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. Br Med J 2:241–245, 1975.
32. Inman WHW, Vessey MP, Westerholm B, Engelund A: Thromboembolic disease and the steroidal content of oral contraceptives. Br Med J 2:203–209, 1970.
33. Stolley PD, Tonascia JA, Tockman MS, et al: Thrombosis with low-estrogen oral contraceptives. Am J Epidemiol 102:197–208, 1975.
34. Vessey MP, Doll R, Fairbairn AS, Glober G: Postoperative thromboembolism and the use of oral contraceptives. Br Med J 3:123–126, 1970.
35. Greene GR, Sartwell PE: Oral contraceptive use in patients with thromboembolism following surgery, trauma or infection. Am J Public Health 62:680–685, 1972.
36. Rosenberg L, Armstrong B, Phil D, Jick H: Myocardial infarction and estrogen therapy in post-menopausal women. N Engl J Med 294:1256–1259, 1976.
37. Coronary Drug Project Research Group: The Coronary Drug Project: Initial findings leading to modifications of its research protocol. JAMA 214:1303–1313, 1970.
38. Baum J, Holtz F, Bookstein JJ, Klein EW: Possible association between benign hepatomas and oral contraceptives. Lancet 2:926–929, 1973.
39. Mays ET, Christopherson WM, Mahr MM, Williams HC: Hepatic changes in young women ingesting contraceptive steroids. Hepatic hemorrhage and primary hepatic tumors. JAMA 235:730–732, 1976.
40. Edmondson HA, Henderson B, Benton B: Liver-cell adenomas associated with use of oral contraceptives. N Engl J Med 294:470–472, 1976.
41. Pfeffer RI, VanDenNoort S: Estrogen use and stroke risk in post-menopausal women. Am J Epidemiol 103:445–456, 1976.
Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised October 2006.
Last reviewed on RxList: 8/25/2009
This monograph has been modified to include the generic and brand name in many instances.
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