戊酸雌二醇注射液 ESTRADIOL VALERATE（商品名：DELESTROGEN）参比制剂 一次性进口
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
上市国家：美国
包装规格及价格
DELESTROGEN 20MG/ML VL 5ML ESTRADIOL VALERATE JHP PHARMACEUTICALS LLC 42023011101 $244.81
DELESTROGEN 40 MG/ML VL 5ML ESTRADIOL VALERATE JHP PHARMACEUTICALS LLC 42023011201 $390.69
DELESTROGEN 10MG VL 5ML ESTRADIOL VALERATE PAR PHARM/BRAND 42023011001 $185.32
DELESTROGEN 40MG/ML 5ML MDV 1/EA ESTRADIOL VALERATE PAR PHARMACEUTICAL INC 42023-0112-01 $821.61
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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 l |
