Bical 50 mg Tablet

Uses

Bical 50 mg Tablet 50 mg daily is used for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

Bical 50 mg Tablet 150 mg daily is not approved for use alone or with other treatments

Bical 50 mg Tablet is also used to associated treatment for these conditions: Stage D2 Prostatic carcinoma

How Bical 50 mg Tablet works

Bical 50 mg Tablet competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue.

Dosage

Bical 50 mg Tablet dosage

The recommended dose for Bical 50 mg Tablet therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bical 50 mg Tablet be taken at the same time each day. Treatment with Bical 50 mg Tablet should be started at the same time as treatment with an LHRH analog.

Side Effects

Anaemia; angioedema, urticaria; decreased appetite, DM, wt gain, dehydration, gout; decreased libido, depression, anxiety, hypertonia, confusion, neuropathy, nervousness, dizziness, somnolence; hot flush; abdominal pain, constipation, nausea, dyspepsia, flatulence, anorexia, rectal haemorrhage, dry mouth, melaena; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, dry skin, pruritus/rash, photosensitivity; haematuria, dysuria, urinary retention, impaired urination, urinary frequency; gynaecomastia, breast tenderness, erectile dysfunction; asthenia, oedema, chest pain, neck pain, fever, sepsis, chills, neoplasm; cough, pharyngitis, bronchitis, pneumonia, rhinitis.

Precaution

Patient with decreased bone density, history of or risk factors for QT prolongation, diabetes, Moderate to severe hepatic and severe renal impairment (CrCl <30 mL/min).

Interaction

May induce torsade de pointes or QT prolongation if co-administered with class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmic agents, methadone, antipsychotics, moxifloxacin. Enhanced anticoagulant effect of warfarin. Increased adverse effects when used with drugs that may inhibit oxidation (e.g. cimetidine, ketoconazole). May increase serum levels of ciclosporin and Ca channel blockers.

Food Interaction

• Take at the same time every day.
• Take with or without food. Food does not significantly affect absorption.

Bical 50 mg Tablet Drug Interaction

Unknown: aspirin, aspirin, aspirin, aspirin, rosuvastatin, rosuvastatin, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, tamsulosin, tamsulosin, leuprolide, leuprolide, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol

Bical 50 mg Tablet Disease Interaction

Moderate: hepatic dysfunction

Elimination Route

Bical 50 mg Tablet is well-absorbed following oral administration, although the absolute bioavailability is unknown.

Half Life

5.9 days

Clearance

• Apparent oral cl=0.32 L/h [Normal Males]

Pregnancy & Breastfeeding use

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: Bical 50 mg Tablet is not indicated for use in women.

Contraindication

Females, children, Pregnancy and lactation. Concomitant use of terfenadine, astemizole or cisapride.

Special Warning

Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.

Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary.

Pediatric Use: The safety and effectiveness of Bical 50 mg Tablet in pediatric patients have not been established.

Geriatric Use: In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.

Women: Bical 50 mg Tablet has not been studied in women.

Acute Overdose

Long-term clinical trials have been conducted with dosages up to 200 mg of Bical 50 mg Tablet daily and these dosages have been well tolerated. A single dose of Bical 50 mg Tablet 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 Bical 50 mg Tablet, 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 Bical 50 mg Tablet 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.

Storage Condition

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

Innovators Monograph

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