TOPOTECAN HYDROCHLORIDE FOR is a brand name for Topotecan, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
5 mg / m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. Because median time to response in three ovarian cancer clinical trials was 9 to 12 weeks and median time to response in four small cell lung cancer trials was 5 to 7 weeks, a minimum of 4 courses of Topotecan hydrochloride for Injection is recommended.
Subsequent doses Topotecan hydrochloride for Injection should not be re-administered unless the absolute neutrophil count is more than or equal to 1x109 / L, the platelet count is more than or equal to 100x109 / L, and the hemoglobin level is more than or equal to 90 g / L (after transfusion if necessary).
g. G-CSF) or to dose reduce to maintain neutrophil counts. 0 mg / m2 /day if necessary). Doses should be similarly reduced if the platelet count falls below 25x109 / L. Routine pre-medication for the prevention of non-hematological adverse events is not required with Topotecan hydrochloride for Injection.
7 to < 171 micromol / L). 67 to 1 mL / sec). 65 mL / sec). Advice on dosing of topotecan for patients with moderate renal impairment (creatinine clearance of 20 to 39 mL / min) is based on studies involving patients with advanced cancer.
33 mL / sec) is not recommended (see CONTRAINDICATIONS). 25 mg / m2 for subsequent courses of therapy is recommended. (see WARNINGS AND PRECAUTIONS, Neutropenia) Use in Children: Insufficient data are available in pediatric patients to provide a dosage recommendation (see PRECAUTIONS AND WARNINGS).
Use in the Elderly:
No dosage adjustment appears to be needed in the elderly, other than adjustments related to renal function. v. administration of Topotecan hydrochloride, drug-related diarrhea (Grade 1 / 2) was 10% in patients greater than 65 years of age (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions, Gastrointestinal).
Patients over the age of 65 should be closely monitored for diarrhea and treated accordingly.
Dosage in Combination with Cytotoxic Agents:
Dose adjustment may be necessary if topotecan is administered in combination with other cytotoxic agents (see DRUG INTERACTIONS). Administration Topotecan hydrochloride for Injection is a cytotoxic anticancer drug. As with other potentially toxic compounds, Topotecan hydrochloride for Injection should be prepared under a vertical laminar flow hood while wearing gloves and protective clothing.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Topotecan in Canada.
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If Topotecan hydrochloride for Injection solution contacts the skin; wash the skin immediately and thoroughly with soap and water. If Topotecan hydrochloride for Injection contacts mucous membranes, flush thoroughly with water.
Preparation for Intravenous Administration:
Topotecan hydrochloride, Lyophilized powder for injection Topotecan hydrochloride for Injection should be diluted only in Polyethylene (PE) bags. Each Topotecan hydrochloride for Injection 4 mg vial is reconstituted with 4 mL Sterile Water for Injection, giving a final concentration of 1 mg / mL.
9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration. Product Monograph – Topotecan Hydrochloride for Injection Page 15 of 32 Since the vials contain no preservative, it is recommended that the product be used immediately after reconstitution.
If not used immediately the reconstituted product should be stored in a refrigerator, for up to 24 hours. 9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration. Diluted solution of Topotecan hydrochloride Injection are stable for up to 30 days at approximately 20o to 25°C (68° to 77oF) or 2 to 8°C.
As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity and particulate matter, discoloration and leakage prior to administration, whenever solution and container permit. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
There is no known antidote for overdosage with Topotecan […]