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DRUGS & SUPPLEMENTS
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Estracyt Capsules are indicated in the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate.
Estracyt Capsules should not be used in patients with any of the following conditions:
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. Estracyt Capsules should be used with caution in patients with a history of thrombophlebitis, thrombosis, or thromboembolic disorders, especially if they were associated with estrogen therapy. Caution should also be used in patients with cerebral vascular or coronary artery disease.
Glucose Tolerance-Because glucose tolerance may be decreased, diabetic patients should be carefully observed while receiving Estracyt.
Elevated Blood Pressure-Because hypertension may occur, blood pressure should be monitored periodically.
Fluid Retention. Exacerbation of preexisting or incipient peripheral edema or congestive heart disease has been seen in some patients receiving therapy with Estracyt Capsules. Other conditions which might be influenced by fluid retention, such as epilepsy, migraine, or renal dysfunction, require careful observation.
Estracyt may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients.
Because Estracyt may influence the metabolism of calcium and phosphorus, it should be used with caution in patients with metabolic bone diseases that are associated with hypercalcemia or in patients with renal insufficiency. Patients with prostate cancer and osteoblastic metastases are at risk for hypocalcemia and should have calcium levels closely monitored.
Gynecomastia and impotence are known estrogenic effects.
Allergic reactions and angioedema at times involving the airway have been reported.
Because of the possibility of mutagenic effects, patients should be advised to use contraceptive measures.
Certain endocrine and liver function tests may be affected by estrogen-containing drugs. Estracyt may depress testosterone levels. Abnormalities of hepatic enzymes and of bilirubin have occurred in patients receiving Estracyt. Such tests should be done at appropriate intervals during therapy and repeated after the drug has been withdrawn for two months.
Milk, milk products, and calcium-rich foods or drugs may impair the absorption of Estracyt.
Long-term continuous administration of estrogens in certain animal species increases the frequency of carcinomas of the breast and liver. Compounds structurally similar to Estracyt are carcinogenic in mice. Carcinogenic studies of Estracyt have not been conducted in man. Although testing by the Ames method failed to demonstrate mutagenicity for Estracyt phosphate sodium, it is known that both estradiol and nitrogen mustard are mutagenic. For this reason and because some patients who had been impotent while on estrogen therapy have regained potency while taking Estracyt, the patient should be advised to use contraceptive measures.
In a randomized, double-blind trial comparing therapy with Estracyt 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 reported:
Estracyt n=93 | DES n=93 | |
---|---|---|
CARDIOVASCULAR-RESPIRATORY | ||
Cardiac Arrest | 0 | 2 |
Cerebrovascular Accident | 2 | 0 |
Myocardial Infarction | 3 | 1 |
Thrombophlebitis | 3 | 7 |
Pulmonary Emboli | 2 | 5 |
Congestive Heart Failure | 3 | 2 |
Edema | 19 | 17 |
Dyspnea | 11 | 3 |
Leg Cramps | 8 | 11 |
Upper Respiratory Discharge | 1 | 1 |
Hoarseness | 1 | 0 |
GASTROINTESTINAL | ||
Nausea | 15 | 8 |
Diarrhea | 12 | 11 |
Minor Gastrointestinal Upset | 11 | 6 |
Anorexia | 4 | 3 |
Flatulence | 2 | 0 |
Vomiting | 1 | 1 |
Gastrointestinal Bleeding | 1 | 0 |
Burning Throat | 1 | 0 |
Thirst | 1 | 0 |
INTEGUMENTARY | ||
Rash | 1 | 4 |
Pruritus | 2 | 2 |
Dry Skin | 2 | 0 |
Pigment Changes | 0 | 3 |
Easy Bruising | 3 | 0 |
Flushing | 1 | 0 |
Night Sweats | 0 | 1 |
Fingertip-Peeling Skin | 1 | 0 |
Thinning Hair | 1 | 1 |
BREAST CHANGES | ||
Tenderness | 66 | 64 |
Enlargement | ||
Mild | 60 | 54 |
Moderate | 10 | 16 |
Marked | 0 | 5 |
MISCELLANEOUS | ||
Lethargy Alone | 4 | 3 |
Depression | 0 | 2 |
Emotional Lability | 2 | 0 |
Insomnia | 3 | 0 |
Headache | 1 | 1 |
Anxiety | 1 | 0 |
Chest Pain | 1 | 1 |
Hot Flashes | 0 | 1 |
Pain in Eyes | 0 | 1 |
Tearing of Eyes | 1 | 1 |
Tinnitus | 0 | 1 |
LABORATORY ABNORMALITIES | ||
Hematologic | ||
Leukopenia | 4 | 2 |
Thrombopenia | 1 | 2 |
Hepatic | ||
Bilirubin Alone | 1 | 5 |
Bilirubin and LDH | 0 | 1 |
Bilirubin and SGOT | 2 | 1 |
Bilirubin, LDH and SGOT | 2 | 0 |
LDH and/or SGOT | 31 | 28 |
Miscellaneous | ||
Hypercalcemia-Transient | 0 | 1 |
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 gastric contents should be evacuated by gastric lavage and symptomatic therapy should be initiated. Hematologic and hepatic parameters should be monitored for at least 6 weeks after overdosage of Estracyt Capsules.
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 Estracyt Capsules at least 1 hour before or 2 hours after meals. Estracyt should be swallowed with water. Milk, milk products, and calcium-rich foods or drugs (such as calcium-containing antacids) must not be taken simultaneously with Estracyt.
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.1–8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
White opaque capsules, each containing Estracyt phosphate sodium as the disodium salt monohydrate equivalent to 140 mg Estracyt phosphate-bottle of 100 (NDC 0013-0132-02).
NOTE
Estracyt Capsules should be stored in the refrigerator at 36° to 46°F (2° to 8°C).
Rx only
LAB-0088-4.0
June 2007
Pfizer
NDC 0013-0132-02
Estracyt ®
capsules
140 mg*
Estracyt phosphate
sodium capsules
100 Capsules
Rx only
Depending on the reaction of the Estracyt after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Estracyt not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Estracyt addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology