Uses of Calupros: - Prostate cancer Prostate Cancer Hypersensitivity. Females, children. Pregnancy, lactation.

Hormonal Chemotherapy

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.When Bicalutamide is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with Bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.In a subset of patients who have been treated with Bicalutamide and an LHRH agonist, and who discontinue Bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.

How to use Bicalutamide: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Bicalutamide may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Palliative treatment of advanced prostate cancer Adult: When used with gonadorelin analogue: Usual dose: 50 mg once daily. May be started with or at least 3 days before starting gonadorelin analogue therapy. Monotherapy or adjuvant therapy to surgery or radiotherapy in locally advanced prostatic cancer Adult: 150 mg once daily.

Enhances effect of coumarin anticoagulants.

Hypersensitivity. Females, children. Pregnancy, lactation.

Common - Anemia (low number of red blood cells) - Rash - Abdominal pain - Breast enlargement in male - Breast tenderness - Constipation - Decreased appetite - Decreased libido - Depression - Dizziness - Indigestion - Flatulence - Hot flashes - Increased liver enzymes - Nausea - Sleepiness - Weakness - Weight gain >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%)

Pregnancy category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.Nursing Mothers: Bicalutamide is not indicated for use in women.

Precaution: Monitor liver function regularly in hepatically impaired patients on prolonged therapy. Monitoring serum levels of Prostate Specific Antigen (PSA) may be useful in evaluating the patient's clincial progress. Lactation: Bicalutamide is not indicated for use in women.

Long-term clinical trials have been conducted with dosages up to 200 mg of Bicalutamide daily and these dosages have been well tolerated. A single dose of Bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established. 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.

Store at controlled room temperature, 20° to 25° C.

Hormonal Chemotherapy

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.

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 recommended dose Lactation Not indicated for use in pregnant women; there is no information available on presence of bicalutamide in human milk, or on effects on breastfed infant or on milk production; bicalutamide has been detected in rat milk