Drug ID: 2d00000043
Drug Name: Bicalutamide
Generic Names: Ablu (50 mg) | Bical (50 mg) | Caludec | Calutide 50 | Bicares | Biprosta | Netide | Macabi | Utamide | Tabi | Tabi (50 mg) | Caluran | Cosalon | Calutidie 50 | Casodex
Category: Non-steroidal anti-androgen
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Recommended Dose: Adult: 50 mg (1 tablet) once daily at the same time of day with or without food.
Recommended In: This medication is a non-steroidal anti-androgen, prescribed for prostate cancer. It blocks testosterone action.
Directions For Use: It comes as a tablet to take by mouth, with or without food.
Storage: Store it at controlled room temperature (30°C).
Dosage Forms: Tablet
Side Effects: Body as a Whole- Pain (general), back pain, weakness, pelvic pain, infection, abdominal pain, chest pain headache, flu like syndrome, fever and chills.
Heart- Hot flashes, high blood pressure, chest pain and congestive heart failure.
Gastrointestinal- Constipation, nausea, diarrhea, increased liver enzyme, indigestion, flatulence, loss of appetite, vomiting, blood in stool, dry mouth, difficulty in swallowing and gastrointestinal disorder.
Metabolic- Swelling in the extremities, weight loss, increased blood sugar level, weight gain, blood urea nitrogen and dehydration.
Musculoskeletal - Muscle/joint pain, leg cramps and fractures.
Central Nervous System- Dizziness, drowsiness, tingling, sleeplessness, anxiety, confusion, decreased libido, nervousness and depression.
Respiratory - Difficulty in breathing, increased cough, inflammation of pharynx/bronchus/nose/sinus, asthma and nosebleed.
Skin - Rash, sweating, dry skin, hair loss, itching and skin cancer.
Genitourinary- Blood in urine, urinary tract infection, breast enlargement in male, impotence, painful urination, breast pain, increased urinary frequency, urinary retention and urinary incontinence.
In Case of Overdose: There is no specific antidote; treatment of an overdose should be symptomatic.
In the management of an overdose with bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since bicalutamide is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Avoid If: Limit the intake of alcoholic beverages.
Monitor liver function regularly.
Monitor serum level of prostate specific antigen (PSA) regularly, to evaluate patient's clinical progress.
It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.
Contraindicated in women, lactation, pregnancy; hypersensitivity.
Drug Interaction: Clinical studies have shown that with co-administration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5 fold (for Cmax) and 1.9 fold (for AUC). Hence, caution should be exercised when bicalutamide is co-administered with CYP 3A4 substrates.
In vitro protein-binding studies have shown that bicalutamide can displace coumarin anticoagulants from binding sites. Prothrombin times should be closely monitored in patients already receiving coumarin anticoagulants who are started on bicalutamide and adjustment of the anticoagulant dose may be necessary.