部份中文戊酸雌二醇处方资料（仅供参考）
商品名：DELESTROGEN
英文名：ESTRADIOL VALERATE
中文名：戊酸雌二醇注射液
生产商：JHP PHARMACEUTICALS LLC 
药品分类：雌激素类/长效雌二醇衍生物
适应症
1．补充雌激素不足，治疗女性性腺功能不良、闭经、更年期综合症等。
2．用于晚期前列腺癌的治疗。
3．与孕激素类药合用，能抑制排卵，可作避孕药。
用法用量
肌内注射。
1. 补充雌激素不足，5mg，每4周一次；
2. 前列腺癌，30mg ，1～2周一次，按需调整用量。
不良反应
可有血栓症、皮肤过敏、诱发精神障碍复发、高血压、钠潴留、阴道不规则流血、乳房胀痛、头痛、注射部位红肿、疼痛等。
禁忌
已知或怀疑与雌激素有关的肿瘤(乳腺癌、性器官癌、较大子宫肌瘤等)患者、血栓性静脉炎、肺栓塞患者、子宫内膜异位症患者、未确诊的阴道不规则流血患者禁用。
意事项
1．肝损伤、肾病、心脏病患者、子宫肌瘤、癫痫、糖尿病患者慎用。
2．对诊断的影响：美替拉酮试验反应减低，BSP试验提示滞留，血清结合蛋白碘试验T4摄取减低，去甲肾上腺素导致的血小板凝聚力可增加。
孕妇及哺乳期妇女用药
孕妇及哺乳期妇女禁用。
儿童用药
青春期前儿童禁用。
包装：
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DELESTROGEN 10 MG VL 5ML  ESTRADIOL VALERATE  PAR PHARM/BRAND  42023011001 
DELESTROGEN 40MG/ML 5ML MDV 1/EA  ESTRADIOL VALERATE  PAR PHARMACEUTICAL INC  42023-0112-01
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DELESTROGEN(estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg ben-zyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil.
Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:
INDICATIONS
DELESTROGEN (estradiol valerate injection, USP) is indicated in the:Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of advanced androgen-dependent carcinoma of the prostate(for palliation only).
DOSAGE AND ADMINISTRATION
When estrogen is prescribed for a postmenopausal 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 reeva luated 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.
Care should be taken to inject deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. By virtue of the low viscosity of the vehicles, the various preparations of DELESTROGEN (estradiol
valerate injection, USP) may be administered with a small gauge needle. Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.
DELESTROGEN should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to pale yellow. Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming.
NOTE: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.
Patients should be started at the lowest dose for the indication.
The lowest effective dose of DELESTROGEN has not been determined for any indication. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule our malignancy in the event of persistent or recurring abnormal vaginal bleeding.
See PRECAUTIONS concerning addition of a progestin.
For treatment of moderate to severe vasomotor symptoms, vulvar 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. The usual dosage is 10 to 20 mg DELESTROGEN every four weeks. Attempts to discontinue or
taper medication should be made at 3-month to 6-month intervals.
For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. The usual dosage is 10 to 20 mg DELESTROGEN every four weeks.
For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.
The usual dosage is 30 mg or more administered every one or two weeks.
HOW SUPPLIED
DELESTROGEN® (estradiol valerate injection, USP)
Multiple Dose Vials
10 mg/mL (5 mL): NDC 42023-110-01
20 mg/mL (5 mL): NDC 42023-111-01
40 mg/mL (5 mL): NDC 42023-112-01
Storage
Store at room temperature.
Keep out of reach of children.
Prescribing Information as of April 2007. Manufactured and Distributed by: JHP Pharmaceuticals, LLC, Rochester, MI 48307. FDA rev date: 10/11/2007
SIDE EFFECTS
See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal can-didiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia;
endometrial cancer.
Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
Skin
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
Eyes
Retinal vascular thrombosis; intolerance to contact lenses.
Central Nervous System
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
DRUG INTERACTIONS
Drug/Laboratory Test Interactions.
Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased
antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoas-say) or T3 levels by radioimmunoassay. T3 resin uptake
is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin(SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
Increased plasma HDL and HDL2cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
Impaired glucose tolerance.
Reduced response to metyrapone test.