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EMCYT® (estramustine sodium phosphate)

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INDICATIONS AND USAGE

EMCYT Capsules are indicated in the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate.

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DOSAGE AND ADMINISTRATION

The recommended daily dose is 14 mg per kg of body weight (ie, one 140 mg capsule for each 10 kg or 22 lb of body weight), given in 3 or 4 divided doses. Most patients in studies in the United...

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CONTRAINDICATIONS

EMCYT Capsules should not be used in patients with any of the following conditions:

1)
Known hypersensitivity to either estradiol or to nitrogen mustard.
2)
Active...
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WARNINGS

It has been shown that there is an increased risk of thrombosis, including fatal and nonfatal myocardial infarction, in men receiving estrogens for prostatic cancer. EMCYT Capsules should be used with caution in...

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ADVERSE REACTIONS

In a randomized, double-blind trial comparing therapy with EMCYT Capsules in 93 patients (11.5 to 15.9 mg/kg/day) or diethylstilbestrol (DES) in 93 patients (3.0 mg/day), the following adverse effects were...

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OVERDOSAGE

Although there has been no experience with overdosage to date, it is reasonable to expect that such episodes may produce pronounced manifestations of the known adverse reactions. In the event of overdosage, the...

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DESCRIPTION

Estramustine phosphate sodium, an antineoplastic agent, is an off-white powder readily soluble in water. EMCYT Capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt...

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CLINICAL PHARMACOLOGY

Estramustine phosphate (Figure 1) is a molecule combining estradiol and nornitrogen mustard by a carbamate link. The molecule is phosphorylated to make it water soluble.

...
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REFERENCES

1.
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83–2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC, 20402.
...
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HOW SUPPLIED

White opaque capsules, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate—bottle of 100 (NDC 0013-0132-02).

NOTE...

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