Drug: Dienestrol

1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA. Three independent case control studies have shown an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods. 1-3 This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems, an increase which may berelated to the rapidly expanding use ofestrogens during the last decade. 4 The three case control studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment 1 and on estrogen dose.3 In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration; 3 it therefore appears prudent to utilize such a regimen. Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recur-ring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy. There is no evidence at present that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses. 2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY. The use of female sex hormones, both estrogens and progestogens, during early pregnancy mayseriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a non-sterodial estrogen, have an increased risk of developing in later life a form of vaginal or cervical cancer that ordinarily is extremely rare. 5,6 This risk has been estimated as not greater than 4 per 1,000 exposures. 7 Furthermore, a high percentage of such exposed women (from 30 to 90 percent) have been found to have vaginal adenosis, 8,13 epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use ofother estrogens, it cannot be presumed they would not induce similar changes. Several reports suggest an association between intra-uterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. 13-16 One case control study16 estimated a 4.7 fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some ofthese exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1,000. In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well controlled studies that progestogens are effective for these uses. If ORTHO Dienestrol Cream is used during pregnancy, or if the patient becomes pregnant while using this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation.
ORTHO Dienestrol Cream Cream for intravaginal use only Active Ingredient: Dienestrol 0.01 % Dienestrol is a synthetic, non-steroidal estrogen. It is compounded in a cream base suitable for intravaginal use only. The cream base is composed of glyceryl monostearate, peanut oil, glycerin, benzoic acid, glutamic acid, butylated hydroxyanisole, citric acid, sodium hydroxide and water. The pH is approximately 4.3.

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(See WARNINGS regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gall bladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism.) The following additional adverse reactions have been reported with estrogenic therapy, including oral contraceptives: 1. Genitourinary system.
    Increase in size of uterine fibromyomata. Vaginal candidiasis. Breakthrough bleeding, spotting, change in menstrual flow. Dysmenorrhea. Premenstrual-like syndrome. Amenorrhea during and after treatment. Change in cervical eversion and in degree of cervical secretion. Cystitis-like syndrome.
2. Breasts.
    Tenderness, enlargement, secretion.
3. Gastrointestinal.
    Cholestatic jaundice. Nausea, vomiting. Abdominal cramps, bloating.
4. Skin.
    Erythema multiforme. Erythema nodosum. Hemorrhagic eruption. Loss of scalp hair. Hirsutism. Chloasma or melasma which may persist when drug is discontinued.
5. Eyes.
    Steepening of corneal curvature. Intolerance to contact lenses.
6. CNS.
    Mental depression. Headache, migraine, dizziness. Chorea.
7. Miscellaneous.
    Reduced carbohydrate tolerance. Aggravation of porphyria. Edema. Changes in libido. Increase or decrease in weight.
Read the Dienestrol (dienestrol) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

Drug/ Laboratory Test Interactions Certain endocrine and liver function tests may be affected by estrogen-containing oral contraceptives. The following similar changes may be expected with larger doses of estrogen:
  1. Increased sulfobromophthalein retention.
  2. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
  3. Increased thyroid-binding globulin (TBG) leading to in-creased circulating total thyroid hormone; as measured by PBI, T4 by column, or T4 by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
  4. Impaired glucose tolerance.
  5. Decreased pregnanediol excretion.
  6. Reduced response to metyrapone test.
  7. Reduced serum folate concentration.
  8. Increased serum triglyceride and phospholipid concentration.
Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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)

Source: http://www.rxlist.com

Estrogens may cause fetal harm when administered to a pregnant woman (see BOXED WARNING). Estrogens are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. Estrogens should also not be used in women with any of the following conditions:
  1. Known or suspected cancer of the breast.
  2. Known or suspected estrogen-dependent neoplasia.
  3. Undiagnosed abnormal genital bleeding.
  4. Active thrombophlebitis or thromboembolic disorders.
  5. A past history of thrombophlebitis, thrombosis, or thrombo-embolic disorders associated with previous estrogen use.
Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that serious ill effects do not occur. Overdosage of estrogen may cause nausea, and withdrawal bleeding may occur in females.

Source: http://www.rxlist.com

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. Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General
  1. A complete medical and family history should be taken prior to the initiation of any estrogen therapy. The pretreatment and periodic physical examinations should include special refer-ence to blood pressure, breasts, abdomen, and pelvic organs, and should include a Papanicolaou smear. As a general rule, estrogen should not be prescribed for longer than one year without another physical examination being performed.
  2. Fluid retention - Because estrogens may cause somedegree of fluid retention, conditions which might be influenced by this factor such as epilepsy, migraine, and cardiac or renal dys-function, require careful observation.
  3. Certain patients may develop undesirable manifestations of excessive estrogenic stimulation, such as abnormal or excessive uterine bleeding, mastodynia, etc.
  4. Oral contraceptives appearto be associated with an increased incidence of mental depression. 24Although it is notclear whether this is due tothe estrogenic or progestogenic component ofthe contraceptive, patients with a history of depression should be carefully observed.
  5. Preexisting uterine leiomyomata may increase in size during estrogen use.
  6. The pathologist should be advised of estrogen therapy when relevant specimens are submitted.
  7. Patients with a past history of jaundice during pregnancy have an increased risk of recurrence of jaundice while receiving estrogen-containing oral contraceptive therapy. If jaundice develops in any patient receiving estrogen, the medication should be discontinued while the cause is investigated.
  8. Estrogens may be poorly metabolized in patients with impaired liver function and they should be administered with caution in such patients.
  9. Because estrogens influence the metabolism of calcium and phosphorus, they should be used with caution in patients with metabolic bone diseases that are associated with hypercalcemia or in patients with renal insufficiency.
  10. Because of the effects ofestrogens on epiphyseal closure, theyshould be used judiciously in young patients in whom bone growth is not complete.
  11. The lowest effective dose appropriate for the specific indication should be utilized. Studies of the addition of a progestin for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endo-metrial hyperplasia. Morphological and biochemical studies of endometrium suggest that 10 to 13 days of progestin are needed to provide maximal maturation of the endometrium and to eliminate any hyperplastic changes. Whether this will provide protection from endometrial carcinoma has not been clearly established. There are possible additional risks which may be associated with the inclusion of progestin in estrogen replacement regimens. The potential risks include adverse effects on carbohydrateand lipid metabolism. The choice of progestin and dosage may be important in minimizing these adverse effects.
Information for Patients See text of Patient Package Information which is reproduced in PATIENT INFORMATION. Carcinogenesis, Mutagenesis, Impairment of Fertility See WARNINGS section for information on carcinogenesis, mutagenesis and impairment of fertility. Pregnancy Teratogenic Effects: Pregnancy Category X. See CONTRAINDICATIONS section. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugsare excreted in human milk, caution should be exercised when estrogens are administered to a nursing woman. Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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