Dacarbazine
Hikma Pharmaceuticals Usa Inc.
Human Prescription Drug
NDC 0143-9245Dacarbazine is a human prescription drug labeled by 'Hikma Pharmaceuticals Usa Inc.'. National Drug Code (NDC) number for Dacarbazine is 0143-9245. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Dacarbazine drug includes Dacarbazine - 10 mg/mL . The currest status of Dacarbazine drug is Active.
Drug Information:
| Drug NDC: | 0143-9245 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dacarbazine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dacarbazine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hikma Pharmaceuticals Usa Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, Lyophilized, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DACARBAZINE - 10 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 08 Aug, 2001 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA075812 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hikma Pharmaceuticals USA Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1731338
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000000236
N0000175558
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 7GR28W0FJI
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Alkylating Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Alkylating Drug [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Alkylating Activity [MoA]
Alkylating Drug [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0143-9245-10 | 10 VIAL in 1 CARTON (0143-9245-10) / 20 mL in 1 VIAL (0143-9245-01) | 08 Aug, 2001 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Dacarbazine dacarbazine dacarbazine dacarbazine mannitol anhydrous citric acid
Boxed Warning:
Warning it is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 1.hemopoietic depression is the most common toxicity with dacarbazine (see warnings ). 2.hepatic necrosis has been reported (see warnings ). 3.studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. 4.in treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
Boxed warning warning it is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. hemopoietic depression is the most common toxicity with dacarbazine (see warnings ). hepatic necrosis has been reported (see warnings ). studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. in treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
Indications and Usage:
Indications and usage dacarbazine for injection, usp is indicated in the treatment of metastatic malignant melanoma. in addition, dacarbazine is also indicated for hodgkin's disease as a second-line therapy when used in combination with other effective agents.
Warnings:
Warnings hemopoietic depression is the most common toxicity with dacarbazine and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. leukopenia and thrombocytopenia may be severe enough to cause death. the possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine. hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. the incidence of such reactions has been low; approximately 0.01% of patients treated. this toxicity has been observed mostly when dacarbazine has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with dacarbazine alone. anaphylaxis can occur following the administration of dacarbazine.
Dosage and Administration:
Dosage and administration malignant melanoma the recommended dosage is 2 to 4.5 mg/kg/day for 10 days. treatment may be repeated at 4 week intervals. an alternate recommended dosage is 250 mg/square meter body surface/day i.v. for 5 days. treatment may be repeated every 3 weeks. hodgkin's disease the recommended dosage of dacarbazine in the treatment of hodgkin's disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. treatment may be repeated every 4 weeks. an alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days. dacarbazine 200 mg/vial is reconstituted with 19.7 ml of sterile water for injection. the resulting solution contains 10 mg/ml of dacarbazine having a ph of 3.0 to 4.0. the calculated dose of the resulting solution is drawn into a syringe and administered only intravenously. the reconstituted solution may be further diluted with 5% dex
Read more...trose injection, or sodium chloride injection, and administered as an intravenous infusion. after reconstitution and prior to use, the solution in the vial may be stored at 4°c for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. if the reconstituted solution is further diluted in 5% dextrose injection or sodium chloride injection, the resulting solution may be stored at 4°c for up to 24 hours or at normal room conditions for up to 8 hours. procedures for proper handling and disposal of anticancer drugs should be considered. several guidelines on this subject have been published. 1-7 there is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration whenever solution and container permit.
Contraindications:
Contraindications dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Adverse Reactions:
Adverse reactions symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. over 90% of patients are affected with the initial few doses. the vomiting lasts 1 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with dacarbazine. rarely, dacarbazine has caused diarrhea. some helpful suggestions include restricting the patientâs oral intake of food for 4 to 6 hours prior to treatment. the rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days. there are a number of minor toxicities that are infrequently noted. patients have experienced an influenza-like syndrome of fever to 39°c, myalgias and malaise. these symptoms occur usually after large single doses, may last for several days, and they may occur
Read more...with successive treatments. alopecia has been noted as has facial flushing and facial paresthesia. there have been few reports of significant liver or renal function test abnormalities in man. however, these abnormalities have been observed more frequently in animal studies. erythematous and urticarial rashes have been observed infrequently after administration of dacarbazine. rarely, photosensitivity reactions may occur. overdosage give supportive treatment and monitor blood cell counts.
Use in Pregnancy:
Pregnancy teratogenic effects; pregnancy category c dacarbazine has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. dacarbazine when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. in rabbits, dacarbazine daily dose 7 times the human daily dose given on days 6 to 15 of gestation resulted in fetal skeletal anomalies. there are no adequate and well-controlled studies in pregnant women. dacarbazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for dacarbazine in animal studies, a decision should be made whether to discontinue nursing or to discontinue t
Read more...he drug, taking into account the importance of the drug to the mother.
Overdosage:
Overdosage give supportive treatment and monitor blood cell counts.
Description:
Description dacarbazine for injection, usp is a colorless to an ivory colored solid which is light sensitive. each vial contains 200 mg of dacarbazine (the active ingredient), anhydrous citric acid and mannitol. dacarbazine is reconstituted and administered intravenously (ph 3.0 to 4.0). dacarbazine is an anticancer agent. chemically, dacarbazine is 5-(3,3-dimethyl-1-triazeno)imidazole-4-carboxamide with the following structural formula: c 6 h 10 n 6 o m.w. = 182.19 structural formula
Clinical Pharmacology:
Clinical pharmacology after intravenous administration of dacarbazine, the volume of distribution exceeds total body water content suggesting localization in some body tissue, probably the liver. its disappearance from the plasma is biphasic with initial half-life of 19 minutes and a terminal half-life of 5 hours. in a patient with renal and hepatic dysfunctions, the half-lives were lengthened to 55 minutes and 7.2 hours. the average cumulative excretion of unchanged dacarbazine in the urine is 40% of the injected dose in 6 hours. dacarbazine is subject to renal tubular secretion rather than glomerular filtration. at therapeutic concentrations dacarbazine is not appreciably bound to human plasma protein. in man, dacarbazine is extensively degraded. besides unchanged dacarbazine, 5-aminoimidazole-4-carboxamide (aic) is a major metabolite of dacarbazine excreted in the urine. aic is not derived endogenously but from the injected dacarbazine, because the administration of radioactive daca
Read more...rbazine labeled with 14 c in the imidazole portion of the molecule (dacarbazine-2- 14 c) gives rise to aic-2- 14 c. although the exact mechanism of action of dacarbazine is not known, three hypotheses have been offered: 1.inhibition of dna synthesis by acting as a purine analog 2.action as an alkylating agent 3.interaction with sh groups
How Supplied:
How supplied dacarbazine for injection, usp is supplied as follows: ndc 0143-9245-10 200 mg/vial of sterile dacarbazine in boxes of 10. store in a refrigerator 2° to 8°c (36° to 46°f). to report suspected adverse reactions, contact hikma pharmaceuticals usa inc. at 1-877-845-0689, or the fda at 1-800-fda-1088 or www.fda.gov/medwatch . for product inquiry call 1-877-845-0689.
Package Label Principal Display Panel:
Principal display panel ndc 0143- 9245 -01 rx only dacarbazine for injection, usp 200 mg per vial prepared as the citrate salt for intravenous use cytotoxic agent ndc 0143- 9245 -10 rx only dacarbazine for injection, usp 200 mg per vial prepared as the citrate salt for intravenous use cytotoxic agent 10 single dose sterile vials vial carton
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