Zopecan
Topotecan Hydrochloride Injection
Strength
✓2.5 mg
Pack Size
Vial
Drug Class
Antineoplastic agents: plant alkaloids and other natural products
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Topotecan is a semi-synthetic derivative of camptothecin and a topoisomerase inhibitor.
The chemical name for topotecan hydrochloride is
(S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14-(4H,12H)-dione 1.25 hydrochloride.
It has the molecular formula
C23H23N3O5∙xHCl (x=1.25)
Molecular weight
467.02
It is soluble in water and melts with decomposition at 213°C to 218°C.
Topotecan Injection for intravenous use is supplied as a sterile, non-pyrogenic, clear yellow to yellow-green solution in single-dose vials.
Topotecan Injection is indicated for treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
Topotecan injection is used to treat patients with metastatic ovarian cancer after other treatments have failed.
It is also used to treat a certain type of lung cancer called small cell lung cancer.
Clinical studies have demonstrated effectiveness in platinum-sensitive small cell lung cancer patients and in metastatic ovarian cancer management.
- Verify dosage using body surface area.
- Do not exceed a single dose of 4 mg intravenously.
- Topotecan can cause severe myelosuppression.
- Administer first cycle only to patients with:
- neutrophil counts ≥ 1,500/mm³
- platelet counts ≥ 100,000/mm³
- Monitor blood cell counts regularly during therapy.
- Recommended dosage for Small Cell Lung Cancer:
- 1.5 mg/m² by intravenous infusion over 30 minutes daily
- for 5 consecutive days
- starting on Day 1 of a 21-day cycle
- Dosage adjustments for adverse reactions:
- Reduce dose to 1.25 mg/m²/day for neutrophil counts less than 500/mm³
- or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours after the last dose
- Reduce dose if platelet counts are less than 25,000/mm³ during previous cycle
- Dosage for renal impairment:
- Reduce dose to 0.75 mg/m²/day for creatinine clearance of 20 to 39 mL/min
- Preparation and administration:
- Withdraw appropriate volume from vial and discard unused portion
- Dilute in minimum 50 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection
- Infuse diluted injection over 30 minutes
- Store diluted injection at 20°C to 25°C for no more than 24 hours.