Oplaxel (Paclitaxel) 300mg
Composition:
Each ml contains :
Paclitaxel USP………………6 mg
Polyoxyl 35 Castor Oil ……………527 mg
Dehydrated Alcohol ……………. 49.7% v/v
Indications: Oplaxel is indicated, after failure of first-line or subsequent chemotherapy for the treatment of metastatic carcinoma of the ovary.
Oplaxel is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Oplaxel is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.
Dosage and Administration: All patients should be premedicated prior to Oplaxel administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before Oplaxel , diphenhydramine (or its equivalent) 50 mg I.V 30 to 60 minutes prior to Oplaxel, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before Oplaxel.
In patients previously treated with chemotherapy for ovarian cancer, the recommended regimen is Oplaxel 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
For patients with carcinoma of the breast, Oplaxel at a dose of 175 mg/m2 administered intravenously over 3 hours every 3 weeks has been shown to be effective after failure of chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
For patients with AIDS-related Kaposi's sarcoma, Oplaxel administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended.
Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
Reduce the dose of dexamethasone as one of the three premedication drugs to 10 mg PO (instead of 20 mgPO);
Initiate or repeat treatment with Oplaxel only if the neutrophil count is at least 1000 cells/ mm3.
Preparation for Intravenous Administration : Oplaxel must be diluted prior to infusion. Oplaxel should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP or 5% Dextrose in Ringer's Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle.
Stability : Unopened vials of Oplaxel Injection are stable until the date indicated on the package when stored between 20°- 25° C (68°-77 F), in the original package. Upon refrigeration components in the Oplaxel vial may precipitate, but will redissolve upon reaching room tempera |
