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Vinorelbine tartrate

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Overview

What is NAVELBINE?

NAVELBINE (vinorelbine tartrate) is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:

CHNO•2CHO

M.W. 1079.12

NAVELBINE Injection is a sterile nonpyrogeinc aqueous solution. Each milliliter of solution contains vinorelbine tartrate equivalent to 10 mg vinorelbine in Water for Injection. The pH of NAVELBINE Injection is approximately 3.5.



What does NAVELBINE look like?



What are the available doses of NAVELBINE?

NAVELBINE Injection

Clear colorless to pale yellow solution in single use vials:

1 mL (10 mg/ 1 mL)

5 mL (50 mg/ 5 mL)

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

Nursing Mothers: discontinue drug or nursing taking into consideration importance of drug to mother ()

How should I use NAVELBINE?

NAVELBINE is indicated:

In Combination with Cisplatin 100 mg/m

In Combination with Cisplatin 120 mg/m

Single-Agent


What interacts with NAVELBINE?

Sorry No Records found


What are the warnings of NAVELBINE?

Sorry No Records found


What are the precautions of NAVELBINE?

Sorry No Records found


What are the side effects of NAVELBINE?

Sorry No records found


What should I look out for while using NAVELBINE?

None


What might happen if I take too much NAVELBINE?

There is no known antidote for overdoses of NAVELBINE. 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 ADVERSE REACTIONS section including paralytic ileus, stomatitis, and esophagitis. Bone marrow aplasia, sepsis, and paresis have also been reported. Fatalities have occurred following overdose of NAVELBINE. 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 NAVELBINE?

Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container with a child-resistant closure.Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container with a child-resistant closure.NAVELBINE Injection is a clear, colorless to pale yellow aqueous solution available in single-dose vials with royal blue caps, individually packaged in a carton as:Store the vials at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of NAVELBINE are stable at 25°C (77°F) for up to 72 hours. NAVELBINE is a cytotoxic drug. Follow applicable special handling and disposal procedures. NAVELBINE Injection is a clear, colorless to pale yellow aqueous solution available in single-dose vials with royal blue caps, individually packaged in a carton as:Store the vials at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of NAVELBINE are stable at 25°C (77°F) for up to 72 hours. NAVELBINE is a cytotoxic drug. Follow applicable special handling and disposal procedures. NAVELBINE Injection is a clear, colorless to pale yellow aqueous solution available in single-dose vials with royal blue caps, individually packaged in a carton as:Store the vials at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of NAVELBINE are stable at 25°C (77°F) for up to 72 hours. NAVELBINE 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

The following drug interactions were studied with ketoprofen doses of 200 mg/day. The possibility of increased interaction should be kept in mind when ketoprofen capsule doses greater than 50 mg as a single dose or 200 mg of ketoprofen per day are used concomitantly with highly bound drugs.

Myelosuppression manifested by neutropenia, anemia and thrombocytopenia occur with NAVELBINE® as a single agent and in combination with cisplatin . Neutropenia is the major dose-limiting toxicity with NAVELBINE.  Grade 3-4 neutropenia occurred in 53% of patients treated with NAVELBINE at 30 mg/m per week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with NAVELBINE administered at 30 mg/m per 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 NAVELBINE. Do not administer NAVELBINE to patients with neutrophil counts <1,000 cells/mm.  Adjustments in the dosage of NAVELBINE 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

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