Bal
Dimercaprol
Akorn
Human Prescription Drug
NDC 17478-526Bal also known as Dimercaprol is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Bal is 17478-526. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Bal drug includes Dimercaprol - 100 mg/mL . The currest status of Bal drug is Active.
Drug Information:
| Drug NDC: | 17478-526 |
| 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: | Bal |
| 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: | Dimercaprol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Akorn |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | DIMERCAPROL - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
|
| 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: | NDA |
| 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: | 01 May, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | NDA005939 |
| 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: | Akorn
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 208325
309915
|
| 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. |
| UPC: | 0317478526032
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175472
N0000175473
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 0CPP32S55X
|
| 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: | Metal Chelating 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: | Metal Chelator [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: | Metal Chelating Activity [MoA]
Metal Chelator [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 |
|---|
| 17478-526-03 | 10 AMPULE in 1 CARTON (17478-526-03) / 3 mL in 1 AMPULE | 01 May, 2012 | 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:
Bal dimercaprol dimercaprol dimercaprol benzyl benzoate peanut oil
Indications and Usage:
Indications bal in oil (dimercaprol injection usp) is indicated in the treatment of arsenic, gold and mercury poisoning. it is indicated in acute lead poisoning when used concomitantly with edetate calcium disodium injection usp. dimercaprol injection usp is effective for use in acute poisoning by mercury salts if therapy is begun within one or two hours following ingestion. it is not very effective for chronic mercury poisoning. dimercaprol injection usp is of questionable value in poisoning caused by other heavy metals such as antimony and bismuth. it should not be used in iron, cadmium, or selenium poisoning because the resulting dimercaprol-metal complexes are more toxic than the metal alone, especially to the kidneys.
Warnings:
Warnings there may be local pain at the site of the injection. a reaction apparently peculiar to children is fever which may persist during therapy. it occurs in approximately 30% of children. a transient reduction of the percentage of polymorphonuclear leukocytes may also be observed.
Dosage and Administration:
Dosage and administration by deep intramuscular injection only. for mild arsenic or gold poisoning, 2.5 mg/kg of body weight four times daily for two days, two times on the third day, and once daily thereafter for ten days; for severe arsenic or gold poisoning, 3 mg/kg every four hours for two-days, four times on the third day, then twice daily thereafter for ten days. for mercury poisoning, 5 mg/kg initially, followed by 2.5 mg/kg one or two times daily for ten days. for acute lead encephalopathy, 4 mg/kg body weight is given alone in the first dose and thereafter at four-hour intervals in combination with edetate calcium disodium injection usp administered at a separate site. for less severe poisoning the dose can be reduced to 3 mg/kg after the first dose. treatment is maintained for two to seven days depending on clinical response. successful treatment depends on beginning injections at the earliest possible moment and on the use of adequate amounts at frequent intervals. other sup
Read more...portive measures should always be used in conjunction with bal in oil (dimercaprol injection usp) therapy. bal in oil should be inspected visually for particulate matter and discoloration prior to administration.
Contraindications:
Contraindications bal in oil (dimercaprol injection usp) is contraindicated in most instances of hepatic insufficiency with the exception of postarsenical jaundice. the drug should be discontinued or used only with extreme caution if acute renal insufficiency develops during therapy.
Adverse Reactions:
Adverse reactions one of the most consistent responses to dimercaprol injection usp is a rise in blood pressure accompanied by tachycardia. this rise is roughly proportional to the dose administered. doses larger than those recommended may cause other transitory signs and symptoms in approximate order of frequency as follows: (1) nausea and, in some instance, vomiting; (2) headache; (3) a burning sensation in the lips, mouth and throat; (4) a feeling of constriction, even pain, in the throat, chest, or hands; (5) conjunctivitis, lacrimation, blepharal spasm, rhinorrhea, and salivation; (6) tingling of the hands; (7) a burning sensation in the penis; (8) sweating of the forehead, hands and other areas; (9) abdominal pain; and (10) occasional appearance of painful sterile abscesses. many of the above symptoms are accompanied by a feeling of anxiety, weakness, and unrest and often are relieved by administration of antihistamine.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with bal in oil. it is also not known whether bal in oil can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. bal in oil should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. however, because many drugs are excreted in human milk, caution should be exercised when bal in oil is administered to a nursing woman.
Overdosage:
Overdose dosage exceeding 5 mg/kg will usually be followed by vomiting, convulsions and stupor, beginning within 30 minutes and subsiding within 6 hours following injection. amer. hosp. form. serv., 64:00, amer. soc. hosp. pharm., 1977.
Description:
Description dimercaprol injection usp is a colorless or almost colorless liquid chelating agent having a disagreeable, mercaptan-like odor. each 1 ml sterile bal in oil (dimercaprol injection usp) contains: 100 mg dimercaprol in 200 mg benzyl benzoate and 700 mg peanut oil.
Clinical Pharmacology:
Clinical pharmacology the sulfhydryl groups of dimercaprol form complexes with certain heavy metals thus preventing or reversing the metallic binding of sulfhydryl-containing enzymes. the complex is excreted. the sustained presence of dimercaprol promotes continued excretion of the metallic poisons - arsenic, gold and mercury. it is also used in combination with edetate calcium disodium injection usp to promote the excretion of lead.
How Supplied:
How supplied 3 ml (100 mg/ml) ampules, box of 10 (ndc 17478-526-03). storage: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel text for container label: ndc 17478-526-03 bal in oil dimercaprol injection, usp 100 mg/ml for im use only rx only 3 ml ampule principal display panel text for container label
Principal display panel text for carton label: ndc 17478-526-03 bal in oil dimercaprol injection, usp 100 mg/ml for intramuscular injection only 10 ampules (3 ml each) rx only akorn logo principal display panel text for carton label