Bical Tablet
Bicalutamide
50mg
Beacon Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 80.00 AED |
Indications
Bical Tablet is used for:
Prostate Cancer
Adult Dose
Oral
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.
Adult: The recommended dose for Bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening).
Child Dose
Renal Dose
Renal Impairment
Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total bicalutamide or the active R-enantiomer.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity
Women
Pregnancy
Precautions
Severe hepatic injury and fatal hepatic failure have been observed.
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 Bicalutamide150 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.
MONITORING PARAMETERS
Monitor liver function regularly in hepatically impaired patients on prolonged therapy.
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.
Monitoring serum levels of Prostate Specific Antigen (PSA) may be useful in evaluating the patient's clinical progress.
Monitoring blood glucose in patients receiving Bicalutamide in combination with LHRH agonists.
Pregnancy-Lactation
Pregnancy
Contraindicated for use in pregnant women because it can cause fetal harm; not indicated for use in females; there are no human data on use in pregnant women; in animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose
Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception.
Lactation
Not indicated for use in pregnant women; there is no information available on the presence of bicalutamide in human milk, or on effects on breastfed infant or on milk production; bicalutamide has been detected in rat milk
Interactions
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.
Contraindicated (3)
flibanserin
lomitapide
lonafarnib
Serious (33)
aminolevulinic acid oral
aminolevulinic acid topical
avapritinib
axitinib
bosutinib
cobimetinib
elacestrant
eliglustat
entrectinib
fentanyl
fentanyl intranasal
fentanyl transdermal
fentanyl transmucosal
infigratinib (DSC)
ivabradine
lemborexant
lurbinectedin
methyl aminolevulinate
midazolam intranasal
mobocertinib
naloxegol
neratinib
nirogacestat
olaparib
omaveloxolone
palifermin
pemigatinib
pexidartinib
repotrectinib
selumetinib
siponimod
tazemetostat
venetoclax
Adverse Effects
Side effects of Bicalutamide :
>10%
Hot flashes (53%),General pain (35%),Back pain (25%),Asthenia (22%),Constipation (22%),Pelvic pain (21%),Infection (18%),Nausea (15%),Dyspnea (13%),Edema (13%),Peripheral edema (13%),Diarrhea (12%),Hematuria (12%),Nocturia (12%),Abdominal pain (11%),Anemia (11%)
1-10%
Gynecomastia (9%),Rash (9%),UTI (9%),Chest pain (8%),Hypertension (8%),Vomiting (8%),Flu like symptoms (7%),Headache (7%),LFTs elevation (7%),Weight loss (7%),Anorexia (6%),Breast pain (6%),Anxiety (5%)
Arthritis (5%)
Mechanism of Action
Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin, thus preventing the growth of normal and malignant prostatic tissue.
Note
Bical 50mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Bicalutamide. Bical is availble in Bangladesh.
Farmaco BD drug index information on Bical Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.