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DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Copyright © All Samadhan - Operated by M/S. Genius Experts | All Rights Reserved
DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Drug International Ltd. · Tablet
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Bicalutamide is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.
The recommended dose for Bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food.Pediatric Use: The safety and effectiveness of Bicalutamide in pediatric patients have not been established.Hepatic Impairment: Bicalutamide is extensively metabolized by the liver. It should be used with caution in patients with moderate-to-severe hepatic impairment.
R-bicalutamide is an inhibitor of CYP 3A4; therefore, caution should be used when Bicalutamide is co-administered with CYP 3A4 substrates
PT/INR should be closely monitored in patients already receiving coumarin anticoagulants who are started on Bicalutamide
Adverse reactions that occurred in more than 10% of patients receiving Bicalutamide plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia.
Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of Bicalutamide in pregnant women.
Hemorrhage with concomitant use of Coumarin Anticoagulant. Closely monitor the Prothrombin Time (PT) and International Normalized Ratio (INR), and adjust the anticoagulant dose as needed
Gynecomastia and breast pain have been reported during treatment with Bicalutamide 150 mg when used as a single agent as it cause a reduction in glucose tolerance in males
Consideration should be given to monitoring blood glucose in patients receiving Bicalutamide in combination with LHRH agonists
Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases
Pediatric Use: The safety and effectiveness of Bicalutamide in pediatric patients have not been established.Hepatic Impairment: Periodic liver function tests should be considered for hepatic-impaired patients on long-term therapy.Renal Impairment: Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total bicalutamide or the active R-enantiomer.
Hormonal Chemotherapy
Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.