A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Emcyt Indications, Dosage, Storage, Stability - Estramustine
Emcyt Indications, Dosage, Storage, Stability - Estramustine
INDICATIONS
AND USES
EMCYT Capsules are indicated in the palliative treatment of patients with metastatic
and/or progressive carcinoma of the prostate.
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 been treated at a dosage range
of 10 to 16 mg per kg per day.
Patients should be instructed to take EMCYT Capsules at least 1 hour before
or 2 hours after meals. EMCYT should be swallowed with water. Milk, milk products,
and calcium-rich foods or drugs (such as calcium-contraining antacids) must
not be taken simultaneously with EMCYT.
Patients should be treated for 30 to 90 days before the physician determines
the possible benefits of continued therapy. Therapy should be continued as long
as the favorable response lasts. Some patients have been maintained on therapy
for more than 3 years at doses ranging from 10 to 16 mg per kg of body weight
per day.
Procedures for proper handling and disposal of anticancer drugs should be considered.
Several guidelines on this subject have been published. 1-7 There
is no general agreement that all of the procedures recommended in the guidelines
are necessary or appropriate.
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
EMCYT Capsules should be stored at 36° to 46°F (2° to 8°C).
REFERENCES
- 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.
- AMA Council Report, Guidelines for Handling Parenteral Antineoplastics,
JAMA. 1985; 253 (11):1590-1592.
- National Study Commission on Cytotoxic Exposure-Recommendations for Handling
Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National
Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy
and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
- Clinical Oncological Society of Australia. Guidelines and Recommendations
for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.
- Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from
the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians. 1983;
(Sept/Oct) 258-263.
- American Society of Hospital Pharmacists Technical Assistance Bulletin on
Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033-1049.
- OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic)
Drugs. Am J Hosp Pharm. 1986; 43:1193-1204.
Rx only
Manufactured for: Pharmacia & Upjohn Company, Kalamazoo, MI 49001, USA
by: Pharmacia & Upjohn S.p.A., Ascoli Piceno, Italy
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