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VINORELBINE

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Overview

What is VINORELBINE?

Vinorelbine Injection, USP is for intravenous administration. Each vial contains vinorelbine tartrate, USP equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic.

Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity. The chemical name is 3',4'-didehydro-4'-deoxy-'-norvincaleukoblastine [-(*,*)-2,3-dihydroxybutanedioate (1:2)(salt)].

Vinorelbine tartrate has the following structure:

Vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula CHNO•2CHOand molecular weight of 1079.12. The aqueous solubility is >1,000 mg/mL in distilled water. The pH of Vinorelbine Injection, USP is approximately 3.5.



What does VINORELBINE look like?



What are the available doses of VINORELBINE?

Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in single use vials:

10 mg/mL Single-Use Vial50 mg/5 mL Single-Use Vial

What should I talk to my health care provider before I take VINORELBINE?

How should I use VINORELBINE?

Vinorelbine Injection, USP is indicated:

In Combination with Cisplatin 100 mg/m

2

In Combination with Cisplatin 120 mg/m

2

Single-Agent


What interacts with VINORELBINE?

Sorry No Records found


What are the warnings of VINORELBINE?

Sorry No Records found


What are the precautions of VINORELBINE?

Sorry No Records found


What are the side effects of VINORELBINE?

Sorry No records found


What should I look out for while using VINORELBINE?

None


What might happen if I take too much VINORELBINE?

There is no known antidote for overdoses of Vinorelbine. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m) have been reported. The toxicities described were consistent with those listed in the section including paralytic ileus, stomatitis, and esophagitis. Bone marrow aplasia, sepsis, and paresis have also been reported. Fatalities have occurred following overdose of Vinorelbine. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors, and antibiotics should be instituted as deemed necessary by the physician.


How should I store and handle VINORELBINE?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in Water for Injection, USP, containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-use, clear glass vials with elastomeric stoppers and green caps, individually packaged in a carton in the following vial sizes:10 mg/mL Single-Use Vial, Carton of 1 (NDC 61703-341-06).50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 61703-341-09).Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in Water for Injection, USP, containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-use, clear glass vials with elastomeric stoppers and green caps, individually packaged in a carton in the following vial sizes:10 mg/mL Single-Use Vial, Carton of 1 (NDC 61703-341-06).50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 61703-341-09).Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in Water for Injection, USP, containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-use, clear glass vials with elastomeric stoppers and green caps, individually packaged in a carton in the following vial sizes:10 mg/mL Single-Use Vial, Carton of 1 (NDC 61703-341-06).50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 61703-341-09).Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in Water for Injection, USP, containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-use, clear glass vials with elastomeric stoppers and green caps, individually packaged in a carton in the following vial sizes:10 mg/mL Single-Use Vial, Carton of 1 (NDC 61703-341-06).50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 61703-341-09).Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. The antitumor activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine may also interfere with: 1) amino acid, cyclic AMP, and glutathione metabolism, 2) calmodulin-dependent Ca++-transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. Vinorelbine inhibited mitotic microtubule formation in intact mouse embryo tectal plates at a concentration of 2 μM inducing a blockade of cells at metaphase, but produced depolymerization of axonal microtubules at a concentration 40 μM, suggesting a modest selectivity of vinorelbine for mitotic microtubules.

Non-Clinical Toxicology
None

Myelosuppression manifested by neutropenia, anemia and thrombocytopenia occur with Vinorelbine as a single agent and in combination with cisplatin []. Neutropenia is the major dose-limiting toxicity with Vinorelbine. Grade 3-4 neutropenia occurred in 53% of patients treated with Vinorelbine at 30 mg/mper week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with Vinorelbine administered at 30 mg/mper week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients. Death due to sepsis occurred in 1% of patients. Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days.

Monitor complete blood counts prior to each dose of Vinorelbine. Do not administer Vinorelbine to patients with neutrophil counts <1,000 cells/mm. Adjustments in the dosage of Vinorelbine should be based on neutrophil counts obtained on the day of treatment [].

The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).