EMCYT Capsule (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Pharmacia and Upjohn Company LLC

Λέξεις κλειδιά

0013-0132

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1. 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 ...

2. 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. <b>Figure 1. Estramustine Phosphate: ...

3. Indications and Usage

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

4. Contraindications

EMCYT Capsules should not be used in patients with any of the following conditions: Known hypersensitivity to either estradiol or to nitrogen mustard. Active thrombophlebitis or thromboembolic disorders, ...

5. 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 ...

6. Precautions

Food/Drug Interaction Milk, milk products, and calcium-rich foods or drugs may impair the absorption of EMCYT.

6.1. General

Fluid Retention. Exacerbation of preexisting or incipient peripheral edema or congestive heart disease has been seen in some patients receiving therapy with EMCYT Capsules. Other conditions which might ...

6.2. Information for Patients

Because of the possibility of mutagenic effects, patients should be advised to use contraceptive measures.

6.3. Laboratory Tests

Certain endocrine and liver function tests may be affected by estrogen-containing drugs. EMCYT may depress testosterone levels. Abnormalities of hepatic enzymes and of bilirubin have occurred in patients ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of estrogens in certain animal species increases the frequency of carcinomas of the breast and liver. Compounds structurally similar to EMCYT are carcinogenic in mice. ...

7. 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 ...

9. 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, ...

10. 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 States have ...

11. 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).

12. Storage and Handling

EMCYT Capsules should be stored in the refrigerator at 36° to 46°F (2° to 8°C).

14. 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. ...