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Rx Item-Etoposide 20Mg/Ml Vial 5Ml By Bluepoint Labs Inj

NDC 68001-0265-25 UPC/GTIN No.3-68001-26525-6 Mfg.Part No.68001-0265-25BRAND: ETOPOSIDE NDC: 68001-0265-25,68001026525 UPC: 3-68001-26525-6,368001265256 Bluepoint LabsOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Etoposide 20Mg/Ml Vial 5Ml By Bluepoint Labs Inj

$11.24$8.39

Item No.:RX390866 NDC No.68001026525 UPC No.:368001265256 NDC No. 68001-0265-25 UPC/GTIN No. 3-68001-26525-6 MPN 68001-0265-25 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx390866 Etoposide 20mg/ml Vial 5ml by Bluepoint Labs Inj Item No. 3390866 NDC No. 68001026525 UPC No. 368001265256 Other Na

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TOPOSAR- etoposide injection, solution, concentrate
Teva Parenteral Medicines, Inc.

Rx only

WARNINGS

TOPOSAR (etoposide injection, USP) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

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-?-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. It has a molecular weight of 588.58 and a molecular formula of C29 H32 O13 .

TOPOSAR is available for intravenous use as a sterile 20 mg/mL solution in 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, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300, dehydrated alcohol 33.2% (v/v).

The structural formula is:

chemical structure
(click image for full-size original)
CLINICAL PHARMACOLOGY

Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Two different dose-dependent responses are seen. At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. It does not interfere with microtubular assembly. The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals.

Pharmacokinetics
On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100-600 mg/m2. Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (Cmax ) values increase linearly with dose. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days.

The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2. Etoposide enters the CSF poorly. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. In vitro , etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved in vivo.

Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide. (See PRECAUTIONS section.)

After intravenous administration of 14 C-etoposide (100-124 mg/m2), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours.

In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known.

Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxy acid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-?-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14 C-etoposide. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.

After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.

In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state. (See PRECAUTIONS section.) Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children.

Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant.

INDICATIONS AND USAGE

TOPOSAR is indicated in the management of the following neoplasms:

Refractory Testicular Tumors
TOPOSAR 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.

CONTRAINDICATIONS

TOPOSAR is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
Pregnancy
Teratogenic Effects
Pregnancy "Category D."
OVERDOSAGE

No proven antidotes have been established for etoposide overdosage.

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 etoposide injection.

TOPOSAR
The usual dose of TOPOSAR in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m2 /day on days 1 through 5 to 100 mg/m2 /day on days 1, 3, and 5.

In small cell lung cancer, the TOPOSAR dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m2 /day for 4 days to 50 mg/m2 /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. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If TOPOSAR solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.
PRECAUTIONS

General
In all instances where the use of etoposide is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of TOPOSAR therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.

Patients with low serum albumin may be at an increased risk for etoposide associated toxicities.

Drug Interactions
High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.

Laboratory Tests
Periodic complete blood counts should be done during the course of etoposide treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of etoposide.

NDC 68001-0265-25 UPC/GTIN No.3-68001-26525-6 Mfg.Part No.68001-0265-25
RX ITEM-Etoposide 20Mg/Ml Vial 5Ml By Bl
NDC 68001-0265-25 UPC/GTIN No.3-68001-26525-6 Mfg.Part No.68001-0265-25

BRAND: ETOPOSIDE NDC: 68001-0265-25,68001026525 UPC: 3-68001-26525-6,368001265256 Bluepoint Labs
Etoposide 20Mg/Ml Vial 5Ml By Bluepoint
BRAND: ETOPOSIDE NDC: 68001-0265-25,68001026525 UPC: 3-68001-26525-6,368001265256 Bluepoint Labs

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ETOPOSIDE INTRAVEN VIAL 2
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.