Bdocin 500 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Capecitabine

Indications/Uses

1st-line treatment of metastatic colorectal carcinoma when treatment w/ fluoropyrimidine therapy alone is preferred. Single agent for adjuvant treatment in patients w/ Dukes' C colon cancer who have undergone complete resection of primary tumor when treatment w/ fluoropyrimidine therapy alone is preferred. Monotherapy for metastatic breast cancer resistant to both paclitaxel & anthracycline-containing chemotherapy regimen or resistant to paclitaxel & for whom further anthracycline therapy is not indicated. In combination w/ docetaxel for metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

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Dosage/Direction for Use

Metastatic CRC or of locally advanced or metastatic breast cancer; adjuvant treatment of colon cancer Monotherapy: 1,250 mg/m² bid (morning & evening; equiv to 2,500 mg/m² total daily dose) for 14 days followed by 7-day rest period. Adjuvant treatment in stage III colon cancer Recommended duration: 6 mth. Colon, colorectal & gastric cancer Combination therapy: Initially 800-1,000 mg/m² bid for 14 days followed by 7-day rest period or to 625 mg/m² bid when administered continuously. Metastatic breast cancer in combination w/ docetaxel 1,250 mg/m² bid for 14 days followed by 7-day rest period + docetaxel 75 mg/m² as 1 hr IV infusion every 3 wk. Premed w/ oral corticosteroid eg, dexamethasone prior to docetaxel administration.

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Overdosage

View Bdocin 500 overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food: Swallow w/ water w/in 30 min after a meal.

Contraindications

Hypersensitivity. History of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ known complete absence of dihydropyrimidine dehydrogenase activity; severe leukopenia, neutropenia, or thrombocytopenia. Treatment w/ sorivudine or its chemically related analogues eg, brivudine. Severe hepatic & renal (CrCl <30 mL/min) impairment. Pregnancy & lactation.

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Special Precautions

Carefully monitor patients w/ severe diarrhea; give fluid & electrolyte replacement if they become dehydrated. Dehydration; hand-foot syndrome; cardiotoxicity eg, MI, angina, dysrhythmias, cardiogenic shock, sudden death & electrocardiographic changes; pre-existing hypo- or hypercalcemia; CNS/peripheral nervous system disease eg, brain metastasis or neuropathy; DM or electrolyte disturbances; Closely monitor INR or prothrombin time in patients receiving concomitant oral coumarin-derivative anticoagulant. Not to be administered concomitantly w/ brivudine. Dihydropyrimidine dehydrogenase deficiency. Patients w/ ophthalmological complications eg, keratitis & corneal disorders, especially w/ history of eye disorders. Severe skin reactions eg, SJS & TEN. Hepatic & renal impairment. Childn. Elderly >60 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anorexia; diarrhea, vomiting, nausea, stomatitis, abdominal pain; palmar-plantar erythrodysaesthesia syndrome, fatigue, asthenia. Herpes viral infection, nasopharyngitis, lower resp tract infection; neutropenia, anaemia; dehydration, decreased wt; insomnia, depression; headache, lethargy, dizziness, paresthesia, dysgeusia; increased lacrimation, conjunctivitis, eye irritation; thrombophlebitis; dyspnoea, epistaxis, cough, rhinorrhoea; GI hemorrhage, constipation, upper abdominal pain, dyspepsia, flatulence, dry mouth; hyperbilirubinaemia, LFT abnormalities; rash, alopecia, erythema, dry skin, pruritus, skin hyperpigmentation & desquamation, rash macular, dermatitis, pigmentation & nail disorder; pain in extremity, back pain, arthralgia; pyrexia, peripheral oedema, malaise, chest pain.

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Drug Interactions

Significant interaction w/ brivudine resulting from inhibition of dihydropyrimidine dehydrogenase by brivudine which leads to increased fluoropyrimidine toxicity. Co-administration w/ CYP2C9 substrates. Altered coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. Increased phenytoin plasma conc resulting in symptoms of phenytoin intoxication. Pharmacodynamics & toxicity may be enhanced by folinic acid. Increased plasma conc w/ Al & Mg hydroxide-containing antacid. Possible decreased efficacy w/ allopurinol. Decreased absorption rate w/ food.

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Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Bdocin 500 FC tab 500 mg

Packing/Price

100's;120's

Bdocin 500

capecitabine

Manufacturer:

BDR Pharmaceutical

Distributor:

Detoxicare

Marketer:

Ambica