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Binecap 500mg tablets

Ferron Par Pharmaceuticals

Ingredients in every tablet

Capecitabine 500 mg

Each package contains

6 blisters of 10 tablets

Dosage form

tablet

Dosage formTablet; coated

Flavour

None

W.H.O. classification

L01B
L01B

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01B

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01B

A.T.C. Level 3

Pharmacological subgroup

L01B - Antimetabolites

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

Breast cancer
– Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
– As monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of a taxane and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Colorectal cancer
– As adjuvant treatment of patients following surgery of stage III (Dukes Stage C) colon cancer.
– As first-line treatment of patients with metastatic colorectal carcinoma.
Gastric cancer
Capecitabine is indicated for treatment of advanced gastric cancer.

Dosage

18 YEARS OLD AND ABOVE
— Colon and colorectal cancer:
The recommended dose of capecitabine in the adjuvant treatment of colon cancer or in the treatment of metastatic colorectal cancer is 1250 mg/m² administered twice daily (morning and evening; equivalent to 2500 mg/m² total daily dose) for 14 days followed by a 7-day rest period. Adjuvant treatment in patients stage III colon cancer is recommended for a total of 6 months, i.e. capecitabine 1250 mg/m² administered twice daily for 14 days followed by a 7-day rest period, given as 3-week cycles total for a total of 8 cycles (24 weeks).

— Advanced gastric cancer:
In combination with a platinum-based compound the recommended dose of capecitabine for the treatment of advanced gastric cancer is 1000 mg/m² administered twice daily for 14 days followed by a 7-days rest period. The first dose of capecitabine should be given on the evening of day 1 and the last dose should be given on the morning of day 15.
Premedication to maintain adequate hydration and anti-emesis according to the cisplatin SPC should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination.

— Breast cancer:
Given as a single agent, the recommended dose of capecitabine in the treatment of locally advanced or metastatic breast cancer is 1250 mg/m² twice daily for 14 days followed by a 7-day rest period.
In combination with docetaxel, the recommended dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m² twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/m² as 1 hour intravenous infusion every 3 weeks. Premedication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics (SPC) should be started prior to docetaxel administration for patients receiving the capecitabine plus docetaxel combination.

Capecitabine should only be prescribed by a qualified physician experienced in utilization of antineoplastic agents. Capecitabine tablets should be swallowed with water within 30 minutes after a meal. Treatment should be discontinued if progressive disease or intolerable toxicity is observed.