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DEPO®-ESTRADIOL (estradiol cypionate)

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WARNINGS

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures including endometrial sampling,...

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INDICATIONS AND USAGE

DEPO-Estradiol Injection is indicated in the treatment of:

  1. Moderate to severe vasomotor symptoms associated with the menopause.
  2. Hypoestrogenism due to...
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DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

...

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CONTRAINDICATIONS

Estrogens should not be used in individuals with any of the following conditions:

  1. Undiagnosed abnormal genital bleeding.
  2. Known or suspected cancer of the breast.
  3. Known or...
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DRUG ABUSE AND DEPENDENCE

Chlorobutanol anhydrous (chloral derivative) added as a preservative may be habit forming.

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OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal...

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DESCRIPTION

DEPO-Estradiol Injection contains estradiol cypionate for intramuscular use. Each mL contains:

5 mg/mL—5 mg estradiol cypionate, 5.4 mg chlorobutanol anhydrous (chloral derivative) added as preservative; in...

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CLINICAL PHARMACOLOGY

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic...

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REFERENCES

  1. Ziel HK, Finkle WD: Increased risk of endometrial carcinoma among users of conjugated estrogens. N Engl J Med 293:1167–1170, 1975.
  2. Smith DC, Prentice R, Thompson DJ, et al: Association...
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HOW SUPPLIED

DEPO-Estradiol Injection is available in the following concentration containing per mL:

5 mg estradiol cypionate; also 5.4 mg chlorobutanol anhydrous (chloral deriv.) added as...

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PATIENT INFORMATION

DEPO-Estradiol®

Brand of estradiol cypionate injection, USP

Read this PATIENT INFORMATION before you start taking...

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LAB-0083-5.0
Revised June 2019

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