Naprocap Dosage & Drug Information

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

Concise Prescribing Info

Contents

Capecitabine

Indications/Uses

1st-line treatment of advanced gastric cancer in combination w/ platinum-based regimen. 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. 1st-line treatment of metastatic colorectal carcinoma when treatment w/ fluoropyrimidine therapy alone is preferred. Monotherapy or in combination w/ docetaxel for metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

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Dosage/Direction for Use

Metastatic colorectal & breast cancer; adjuvant colorectal cancer Monotherapy: 1,250 mg/m² bid for 2 wk followed by 1-wk rest period given as 3-wk cycles. Patient w/ Dukes' C colon cancer Adjuvant treatment: Recommended for a total of 6 mth. Metastatic breast cancer Combination therapy w/ docetaxel: 1,250 mg/m² bid for 2 wk followed by 1-wk rest period combined w/ docetaxel at 75 mg/m² as a 1-hr IV infusion every 3 wk.

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Overdosage

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Administration

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

Contraindications

Hypersensitivity to capecitabine & 5-fluorouracil (5-FU). Patients w/ known dihydropyrimidine dehydrogenase (DPD) deficiency. Severe renal impairment (CrCl <30 mL/min).

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Warnings

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Special Precautions

Carefully monitor patients w/ severe diarrhea; give fluid & electrolyte replacement if they become dehydrated. Closely monitor INR or prothrombin time in patients receiving concomitant oral coumarin-derivative anticoagulant. Possible cardiotoxicity including MI/ischemia, angina, dysrhythmias, cardiac arrest/failure, sudden death, ECG changes & cardiomyopathy. DPD deficiency. Possible hand & foot syndrome; hyperbilirubinemia; neutropenia, thrombocytopenia or decreased Hb. Carefully monitor patients w/ mild or moderate renal impairment; those w/ moderate renal impairment at baseline require dose reduction. Severe hepatic dysfunction; carefully monitor patients w/ mild to moderate hepatic dysfunction due to liver metastases. Advise women to avoid becoming pregnant while receiving treatment. Pregnancy & lactation. Childn <18 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea, stomatitis, vomiting, abdominal pain, constipation, upper abdominal pain, dyspepsia, GI motility disorder & hemorrhage, oral discomfort, upper GI inflammatory disorder, ileus, dry mouth; hand & foot syndrome, alopecia, rash, erythema, dermatitis, skin discoloration, rash erythematous, nail disorder & discoloration, onycholysis, pruritus; fatigue, pyrexia, asthenia, lethargy, weakness, chest & limb pain, flu-like illness; dizziness, headache, dysgeusia, peripheral sensory neuropathy, insomnia, paresthesia, hypoaesthesia; anorexia, decreased appetite & wt, dehydration; conjunctivitis, eye irritation, abnormal vision, increased lacrimation; neutropenia, anemia, neutropenic fever, thrombocytopenia, lymphocytopenia, granulocytopenia; epistaxis, dyspnea, cough, pharyngeal disorder, sore throat, rhinorrhea, pleural effusion; arthralgia, myalgia, bone & back pain; venous thrombosis, flushing, lymphoedema; mood alteration, depression; viral, oral candidiasis, UTI, URTI.

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Drug Interactions

Altered coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants (eg, warfarin & phenprocoumon). May elevate phenytoin levels. 5-FU conc & toxicity may be enhanced by leucovorin. Co-administration w/ CYP2C9 substrates. Pharmacodynamics & toxicity may be enhanced by folinic acid. May increase fluoropyrimidine toxicity by sorivudine or its chemically-related analogues (eg, brivudine). Increased plasma conc w/ Al & Mg hydroxide-containing antacid. Possible decreased efficacy of 5-FU w/ allopurinol.

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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

Naprocap FC tab 500 mg

Packing/Price

10's

Naprocap

capecitabine

Manufacturer:

Naprod

Distributor:

Multicare

Marketer:

Multicare