ow 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 erup |
