Dirogit Tablets / Film-coated

Capecitabine
500mg
Hikma Pharmaceuticals
Pack size 120 Tablets
Dispensing mode POM
Source JORDAN
AgentALPHAMED CO. (AUH) LTD.
Retail Price 869.50 AED

Indications

Dirogit Tablets / Film-coated is used for: Breast cancer, Colorectal cancer, Gastric cancer, Oesophageal cancer

Adult Dose

Oral Breast cancer; Colorectal cancer Adult: 1.25 g/m2 bid for 2 wk followed by a 1 wk rest period; therapy to be given in 3-wk cycles. Recommended treatment duration for colorectal cancer: 6 mth. May be used in combination with docetaxel at 75 mg/m2, given as a 1-hr IV infusion once every 3 wk for the treatment of breast cancer. Gastric cancer Adult: Used in combination with a platinum-based compound, 1 g/m2 bid for 14 days, followed by a 7-day rest period. 1st dose is given on the evening of day 1 and the last dose on the morning of day 15.

Child Dose

Renal Dose

Renal impairment: CrCl (ml/min) 51-80 No adjustment needed. 30-50 Reduce dose to 950 mg/m2 bid when starting dose is 1.25 g/m2 bid. No dose adjustment is needed when starting dose is 1 g/m2. <30 Avoid use.

Administration

Swallow with water within 30 min after a meal

Contra Indications

History of severe and unexpected reactions to fluoropyrimidine therapy; severe renal impairment; pregnancy, lactation. Hypersensitivity.

Precautions

Hepatic dysfunction, bone marrow suppression, poor nutritional status, warfarin therapy. Child, elderly, prior extensive pelvic radiation or alkylating therapy. Moderate renal impairment; CBC with differential; monitor hepatic and renal function. Discontinue use if intractable diarrhoea, stomatitis, bone marrow suppression or MI develops.

Pregnancy-Lactation

Pregnancy Category: C Lactation: excretion in milk unknown; use with caution

Interactions

Antacids containing aluminum and magnesium, leucovorin, anticoagulants, phenytoin, allopurinol.

Adverse Effects

Side effects of Capecitabine : 10% Diarrhea, Nausea, Anemia, Lymphopenia, Hand and foot syndrome, Edema, Fatigue, Fever, Headache, Pain, Paresthesia, Alopecia, Dermatitis, Abdominal pain, Anorexia, Appetite decreased, Constipation, Dyspepsia, Stomatitis, Vomiting, Neutropenia, Thrombocytopenia, Dyspnea, Bilirubin increased, Eye irritation 1-10% Chest pain, Dermatitis, Pruritus, Rash, Dizziness, Headache, Weakness, Dehydration, Dry mouth, Dyspepsia, Taste disturbance, Back pain Potentially Fatal: Cardiotoxicity, bone-marrow depression and hyperbilirubinaemia.

Mechanism of Action

Capecitabine is a prodrug that is converted to fluorouracil following oral administration, which in turn inhibits thymidylate synthetase, blocking the methylation of deoxyuridylic acid to thymidylic acid, interfering with DNA, and to a lesser degree, RNA synthesis.

Note

Dirogit 500mg Tablets / Film-coated manufactured by Hikma Pharmaceuticals. Its generic name is Capecitabine. Dirogit is availble in United Arab Emirates. Farmaco UAE drug index information on Dirogit Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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