Medicinal Products

BICALUTAMIDE EG 50 mg

Generic drug of Casodex
Therapeutic class: Oncology and hematology
Active ingredients: Bicalutamide
laboratory: EG Labo

Coated tablet
Box of 30
All forms

Indication

- Advanced prostate cancer: Treatment of advanced prostate cancer associated with treatment with a luteinizing hormone releasing hormone (LHRH) analogue or surgical castration (daily dose: 50 mg bicalutamide). - Locally advanced prostate cancer: Bicalutamide (at a daily dose of 150 mg) is indicated either as monotherapy or as adjunctive therapy to radical prostatectomy or radiotherapy in patients with locally advanced prostate high risk of disease progression (see section on pharmacodynamic properties).

Dosage BICALUTAMIDE EG 50 mg Film-coated tablet Box of 30

- Adults of males, including the elderly:
. Advanced prostate cancer :
One 50 mg tablet once a day.
Route of administration: oral. The tablets should be swallowed whole with water.
Treatment with bicalutamide should be initiated at least 3 days before starting treatment with an LHRH analogue, or at the same time as surgical castration.
. Locally advanced prostate cancer :
Three 50 mg (150 mg) tablets once a day.
Route of administration: oral. The tablets should be swallowed whole with water.
Bicalutamide 150 mg should be taken continuously for at least 2 years or until the disease progresses.
- Children and adolescents:
Bicalutamide is not indicated for children and adolescents.
- Renal failure :
No dose adjustment is necessary in patients with renal impairment. There are no data on the use of bicalutamide in patients with severe renal impairment (creatinine clearance <30 ml / min) (see section on warnings and precautions for use).
- Hepatic insufficiency :
No dose adjustment is necessary in patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see section cautionary statements and precautions for use).

Against indications

- Hypersensitivity to bicalutamide or any of the excipients.
- Women.
- Children.
- History of hepatic toxicity associated with taking bicalutamide.
- This product contains lactose . Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption should not take this medicine.
- Concomitant administration of terfenadine, astemizole or cisapride with bicalutamide is contraindicated (see section interactions).

Side effects Bicalutamide EG

Very common (> = 1/10) frequent (from> = 1/100 to = 1/1000 to = 1/10000 to <1/1000); very rare (<1/10000); unknown (can not be estimated from available data).
- Respiratory, thoracic and mediastinal disorders:
Uncommon : Interstitial lung disease.
- Gastrointestinal disorders:
. Frequent : Diarrhea, nausea.
. Rare : Vomiting.
- Renal and urinary disorders:
Uncommon : Hematuria.
- Skin and subcutaneous tissue disorders:
Frequency : Pruritus, dry skin.
- General disorders and anomalies at the site of administration:
Very common : Hot flashes (3), asthenia.
- Immune system disorders:
Uncommon : Hypersensitivity reactions, including angioneurotic edema and urticaria.
- Hepatobiliary disorders:
. Frequent : Hepatic changes (elevated transaminase levels, bilirubinemia, hepatomegaly, cholestasis and jaundice) (1).
. Rare : Severe hepatic insufficiency, hepatic insufficiency (2).
- Reproductive system disorders and breast conditions:
Very common : chest pain to the touch (3), gynecomastia (3).
- Psychiatric disorders:
Uncommon : Depression.
(1) Liver changes are rarely severe, usually transient, disappearing or improving with continued treatment or after discontinuation of treatment (see section on warnings and precautions for use).
(2) Hepatic failure has occurred very rarely in patients treated with bicalutamide, but no causal relationship has been established with certainty. Periodic liver function tests should be considered (see also section on warnings and precautions for use).
(3) Can be reduced by concomitant castration.
IN ADDITION, THE FOLLOWING ADVERSE REACTIONS HAVE BEEN REPORTED IN CLINICAL TRIALS during treatment with bicalutamide with and without LHRH analogue:
- Cardiac disorders:
Very rare : Heart failure, angina, conduction disturbances (including prolongation of PR and QT intervals), arrhythmias and nonspecific ECG changes.
- Blood and lymphatic system disorders:
. Frequency : Anemia.
. Very rare : Thrombocytopenia.
- disorders of the nervous system:
. Frequent : Dizziness, drowsiness.
. Uncommon : Insomnia.
- Respiratory, thoracic and mediastinal disorders:
Uncommon : Dyspnoea.
- Gastrointestinal disorders:
. Frequent : Constipation.
. Uncommon : Dry mouth, gastro-intestinal disorder, dyspepsia, flatulence.
- Renal and urinary disorders:
Uncommon : Nocturia.
- Skin and subcutaneous tissue disorders:
Frequent : rash, maculopapular rash, sweating, hirsutism, alopecia.
- Metabolism and nutrition disorders:
. Frequent : Diabetes, weight gain.
. Uncommon : Anorexia, hyperglycemia, weight loss.
- General disorders and anomalies at the site of administration:
. Common : Edema (face, extremities, trunk), generalized pain, pelvic pain, chills.
. Uncommon : Abdominal pain, chest pain, headache, pain in the back, pain in the neck.
- Reproductive system disorders and breast conditions:
Very common : Decreased libido, erectile dysfunction, impotence.

Popular Posts

Category Medicinal Products, Next Article