Drug Catalog - Product Detail
TOPOSAR FOR INJECTION INJECT. 20MG/ML 1X50ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00703-5657-01 | TEVA PARENTERAL MEDICINES | 50 | 1GM/50ML | SOLUTION |
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Description
DESCRIPTION Toposar ® (etoposide injection USP) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Toposar (etoposide injection USP) is available for intravenous use as a sterile 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials. The pH of the clear, yellow liquid is 3.0 to 4.0. Each mL contains: 20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v). The structural formula is: C 29 H 32 O 13 M.W. 588.56 chemical structure
How Supplied
HOW SUPPLIED Toposar ® (etoposide injection USP), 20 mg/mL is supplied as follows: NDC Number Contents Size 0703-5653-01 100 mg 5 mL Multiple-dose Vials 0703-5656-01 500 mg 25 mL Multiple-dose Vials 0703-5657-01 1 gram 50 mL Multiple-dose Vials All are available individually packaged. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT FREEZE.
Indications & Usage
INDICATIONS AND USAGE Toposar (etoposide injection) is indicated in the management of the following neoplasms: Refractory Testicular Tumors Toposar (etoposide injection) in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Dosage and Administration
DOSAGE AND ADMINISTRATION Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with undiluted Toposar Injection. Toposar Injection The usual dose of Toposar Injection in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m 2 /day on days 1 through 5 to 100 mg/m 2 /day on days 1, 3, and 5. In small cell lung cancer, the Toposar Injection dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m 2 /day for 4 days to 50 mg/m 2 /day for 5 days. For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity. The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve. Administration Precautions As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Toposar Injection. Skin reactions associated with accidental exposure to Toposar Injection may occur. The use of gloves is recommended. If Toposar Injection solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. Preparation for Intravenous Administration Toposar Injection must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the Toposar Injection solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. Toposar Injection should not be given by rapid intravenous injection. Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit. Stability Unopened vials of Toposar Injection are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.