Zebical 50mg Tablet

Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments. - Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. - Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Severe hepatic injury and fatal hepatic failure have been observed. Monitor serum transaminase levels prior to starting treatment with Bicalutamide, at regular intervals for the first four months of treatment and periodically thereafter, and for symptoms or signs suggestive of hepatic dysfunction. Use Bicalutamide with caution in patients with hepatic impairment. - 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. - Bicalutamide is used in combination with an LHRH agonist. LHRH agonists have been shown to 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. Hepatitis Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Bicalutamide. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of Bicalutamide patients in controlled clinical trials. Serum transaminase levels should be measured prior to starting treatment with Bicalutamide, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, Bicalutamide should be immediately discontinued with close follow-up of liver function. Hemorrhage with Concomitant Use of Coumarin Anticoagulant In the postmarketing setting, there have been reports of excessive prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) days to weeks after the introduction of Bicalutamide in patients who were previously stable on coumarin anticoagulants. Some patients had serious bleeding including intracranial, retroperitoneal, and gastrointestinal requiring blood transfusion and/or administration of vitamin K. Closely monitor the PT/INR, and adjust the anticoagulant dose as needed. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. Clinical Trials Experience In patients with advanced prostate cancer treated with Bicalutamide in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%). In the multi-center, double-blind, controlled clinical trial comparing Bicalutamide 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported. Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality Body System Adverse Reaction Treatment Group Number of Patients (%) Bicalutamide Plus LHRH Analog (n=401) Flutamide Plus LHRH Analog (n=407) Body as a Whole Pain (General) 142 127 Back Pain 102 105 Asthenia 89 87 Pelvic Pain 85 70 Infection 71 57 Abdominal Pain 46 46 Chest Pain 34 34 Headache 29 27 Flu Syndrome 28 30 Cardiovascular Hot Flashes 211 217 Hypertension 34 29 Digestive Constipation 87 69 Nausea 62 58 Diarrhea 49 107 Increased Liver Enzyme Test 30 46 Dyspepsia 30 23 Flatulence 26 22 Anorexia 25 29 Vomiting 24 32 Hemic and Lymphatic Anemia 45 53 Metabolic and Nutritional Peripheral Edema 53 42 Weight Loss 30 39 Hyperglycemia 26 27 Alkaline Phosphatase Increased 22 24 Weight Gain 22 18 Musculoskeletal Bone Pain 37 43 Myasthenia 27 19 Arthritis 21 29 Pathological Fracture 17 32 Nervous System Dizziness 41 35 Paresthesia 31 40 Insomnia 27 39 Anxiety 20 9 Depression 16 33 Respiratory System Dyspnea 51 32 Cough Increased 33 24 Pharyngitis 32 23 Bronchitis 24 22 Pneumonia 18 19 Rhinitis 15 22 Skin and Appendages Rash 35 30 Sweating 25 20 Urogenital Nocturia 49 55 Hematuria 48 26 Urinary Tract Infection 35 36 Gynecomastia 36 30 Impotence 27 35 Breast Pain 23 15 Urinary Frequency 23 29 Urinary Retention 20 14 Urinary Impaired 19 15 Urinary Incontinence 15 32 Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the Bicalutamide-LHRH analog treatment group are listed bel Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.