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CARMUSTINE

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Overview

What is BiCNU?



What does BiCNU look like?



What are the available doses of BiCNU?

For injection: 100 mg of carmustine as a lyophilized powder in a single-dose vial for reconstitution and a vial containing 3 mL sterile diluent (Dehydrated Alcohol Injection, USP).

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

How should I use BiCNU?

BiCNU is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

The recommended dose of BiCNU as a single agent in previously untreated patients is 150 to 200 mg/m intravenously every 6 weeks. Administer as a single dose or divided into daily injections such as 75 to 100 mg/m on two successive days. Lower the dose when BiCNU is used with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted. Administer BiCNU for the duration according to the established regimen. Premedicate each dose with anti-emetics.

Adjust doses subsequent to the initial dose according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:

The hematologic toxicity can be delayed and cumulative. Monitor blood counts weekly. Do not administer a repeat course of BiCNU until circulating blood elements have returned to acceptable levels (platelets above 100 Gi/L, leukocytes above 4 Gi/L and absolute neutrophil count above 1 Gi/L). The usual interval between courses is 6 weeks.

Evaluate renal function prior to administration and periodically during treatment. For patients with compromised renal function, monitor for toxicity more frequently. Discontinue BiCNU if the creatinine clearance is less than 10 mL/min. Do not administer BiCNU to patients with compromised renal function. Monitor transaminases and bilirubin periodically during treatment.


What interacts with BiCNU?

Sorry No Records found


What are the warnings of BiCNU?

Sorry No Records found


What are the precautions of BiCNU?

Sorry No Records found


What are the side effects of BiCNU?

Sorry No records found


What should I look out for while using BiCNU?

Hypersensitivity (4)

Myelosuppression

BiCNU causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. . Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose . Do not administer a repeat course of BiCNU until blood counts recover.

Pulmonary Toxicity

BiCNU causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/mcumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood .


What might happen if I take too much BiCNU?


How should I store and handle BiCNU?

Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).StabilityStore the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years.Compatibility/ Incompatibility with ContainersThe intravenous solution is unstable in polyvinyl chloride container. .Administer BiCNU solution from the Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side.They are supplied as follows:Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side.They are supplied as follows:You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side.They are supplied as follows:Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side.They are supplied as follows:You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side.They are supplied as follows:Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side.They are supplied as follows:You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side.They are supplied as follows:Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side.They are supplied as follows:You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side.They are supplied as follows:Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side.They are supplied as follows:You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. The metabolites may contribute to antitumor activity and toxicities of carmustine.

Non-Clinical Toxicology
Hypersensitivity (4)

Myelosuppression

BiCNU causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. . Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose . Do not administer a repeat course of BiCNU until blood counts recover.

Pulmonary Toxicity

BiCNU causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/mcumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood .

Lidocaine Hydrochloride Injection, USP should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block. Concomitant use of beta-blocking agents or cimetidine may reduce hepatic blood flow and thereby reduce lidocaine clearance. The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.

Lidocaine and tocainide are pharmacodynamically similar.

Bone marrow toxicity is a dose-limiting, common and severe toxic effect of BiCNU occurring 4-6 weeks after drug administration (thrombocytopenia occurs at about 4 weeks post-administration persisting for 1 to 2 weeks; leukopenia occurs at 5 to 6 weeks after a dose of BiCNU persisting for 1 to 2 weeks; thrombocytopenia is generally more severe than leukopenia; anemia is less frequent and less severe compared to thrombocytopenia and/or leukopenia) Complete blood count should therefore be monitored weekly for at least six weeks after a dose. Repeat doses of BiCNU should not be given more frequently than every six weeks. The bone marrow toxicity of BiCNU is cumulative and therefore the dosage adjustment must be considered on the basis of nadir blood counts from prior dose . Greater myelotoxicity (e.g., leukopenia and neutropenia) has been reported when carmustine was combined with cimetidine .

The following serious adverse reactions are described elsewhere in the labeling:

The following adverse reactions associated with the use of BiCNU were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Tachycardia and chest pain.

Conjunctival edema, conjunctival hemorrhage, blurred vision and loss of depth perception

Nausea, vomiting, anorexia, and diarrhea

Increased transaminase, increased alkaline phosphatase, increased bilirubin levels

Opportunistic infection (including with fatal outcome).

Acute leukemia, bone marrow dysplasias.

Progressive azotemia, decrease in kidney size, renal failure

Headaches, encephalopathy, and seizures

Pneumonitis, interstitial lung disease

Gynecomastia

Burning sensation, hyperpigmentation, swelling, pain, erythema, skin necrosis, alopecia, allergic reaction

Veno-occlusive disease.

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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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