Indications of Toposar 100 mg/5 ml
Small Cell Lung Cancer: Toposar 100 mg/5 ml Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.Toposar 100 mg/5 ml is also indicated in Testicular cancer, Small cell lung cancer
Theropeutic Class
Cytotoxic Chemotherapy
Pharmacology
Toposar 100 mg/5 ml is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.
Dosage & Administration of Toposar 100 mg/5 ml
Intravenous (Adult)-
Small cell lung cancer: 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.Testicular cancer: For combination therapy: 50-100 mg/m2/day from days 1-5, or 100 mg/m2 on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.
Oral (Adult)-
Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.
Dosage of Toposar 100 mg/5 ml
Intravenous (Adult)-
Small cell lung cancer: 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.Testicular cancer: For combination therapy: 50-100 mg/m2/day from days 1-5, or 100 mg/m2 on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.
Oral (Adult)-
Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.
Interaction of Toposar 100 mg/5 ml
Synergism with other cytotoxic drugs. Caution when admin with drugs that inhibit phosphatase activity. Cyclosporin A may reduce the clearance of Toposar 100 mg/5 ml.
Contraindications
Hypersensitivity, pregnancy, lactation.
Side Effects of Toposar 100 mg/5 ml
Leukopenia, Nausea and Vomiting, Thrombocytopenia, Alopecia, Anorexia, Diarrhea, Leukopenia, Anemia, Pancytopenia, Stomatitis, Hepatic toxicity, Type 1 hypersensitivity, Orthostatic hypotension, Peripheral neuropathyMalaise,Shivering,Asthenia,Fever,Mucous membrane inflammation, Hyperuricemia, Local soft tissue toxicity has been reported following extravasation;
Pregnancy & Lactation
Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.Lactation: not known if excreted in breast milk, discontinue drug or do not nurse
Precautions & Warnings
Skin reactions may occur with accidental exposure; renal or hepatic disease. Periodic CBCs should be done before, during and after therapy. Increased risk of Toposar 100 mg/5 ml-toxicity in patients with low serum albumin. Acrylic material has been shown to crack and leak when used with undiluted Toposar 100 mg/5 ml inj.
Use In Special Populations
Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.
Drug Classes
Cytotoxic Chemotherapy
Mode Of Action
Toposar 100 mg/5 ml is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.
Pregnancy
Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.Lactation: not known if excreted in breast milk, discontinue drug or do not nurse
Pediatric Uses
Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.