Dapsone


Aphena Pharma Solutions - Tennessee, Llc
Human Prescription Drug
NDC 43353-222
Dapsone is a human prescription drug labeled by 'Aphena Pharma Solutions - Tennessee, Llc'. National Drug Code (NDC) number for Dapsone is 43353-222. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Dapsone drug includes Dapsone - 25 mg/1 . The currest status of Dapsone drug is Active.

Drug Information:

Drug NDC: 43353-222
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: Dapsone
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: Dapsone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Aphena Pharma Solutions - Tennessee, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
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:DAPSONE - 25 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 01 Jun, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 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: ANDA204074
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:Aphena Pharma Solutions - Tennessee, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:197557
197558
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.
NUI:N0000175881
M0020791
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:8W5C518302
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 EPC:Sulfone [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 CS:Sulfones [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Sulfone [EPC]
Sulfones [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
43353-222-3030 TABLET in 1 BOTTLE (43353-222-30)29 Aug, 2016N/ANo
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:

Dapsone dapsone dapsone dapsone silicon dioxide magnesium stearate cellulose, microcrystalline starch, corn white to off-white 25;102;ncp dapsone dapsone dapsone dapsone silicon dioxide magnesium stearate cellulose, microcrystalline starch, corn white to off-white 100;101;ncp

Drug Interactions:

Drug interactions rifampin lowers dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions. a modest interaction has been reported for patients receiving 100 mg dapsone daily in combination with trimethoprim 5 mg/kg q6h. on day 7, serum dapsone levels averaged 2.1 ± 1.0 mcg/ml in comparison to 1.5 ± 0.5 mcg/ml for dapsone alone. on day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/ml in comparison to 12.4 ± 4.5 mcg/ml for patients not receiving dapsone. thus, there is a mutual interaction between dapsone and trimethoprim in which each raises the level of the other about 1.5 times. a crossover study 1 designed to assess the potential of a drug interaction between dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic hiv positive volunteers (average cd4 count 524 cells/mm 3 ) demonst
rated that there was not a significant drug interaction between dapsone and trimethoprim. however, an earlier report 2 also by lee et al, in 78 hiv infected patients with acute pneumocystis carinii pneumonia, receiving dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.

Indications and Usage:

Indications and usage dermatitis herpetiformis: (d.h.) leprosy: all forms of leprosy except for cases of proven dapsone resistance.

Warnings:

Warnings the patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. deaths associated with the administration of dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. complete blood counts should be done frequently in patients receiving dapsone. the fda dermatology advisory committee recommended that, when feasible, counts should be done weekly for the first month, monthly for six months and semi-annually thereafter. if a significant reduction in leucocytes, platelets or hemopoiesis is noted, dapsone should be discontinued and the patients followed intensively. folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if co-administered with dapsone the patient should be monitored more frequently. patients on weekly pyrimethamine and dapsone have developed agranulocytosis during the second and third month of therapy. severe anemia sho
uld be treated prior to initiation of therapy and hemoglobin monitored. hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease. cutaneous reactions, especially bullous, include exfoliative dermatitis and are probably one of the most serious, though rare, complications of sulfone therapy. they are directly due to drug sensitization. such reactions include toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum. if new or toxic dermatologic reactions occur, sulfone therapy must be promptly discontinued and appropriate therapy instituted. leprosy reactional states, including cutaneous, are not hypersensitivity reactions to dapsone and do not require discontinuation. see special section.

General Precautions:

General hemolysis and heinz body formation may be exaggerated in individuals with a glucose-6-phosphate dehydrogenase (g6pd) deficiency, or methemoglobin reductase deficiency, or hemoglobin m. this reaction is frequently dose-related. dapsone should be given with caution to these patients or if the patient is exposed to other agents or conditions such as infection or diabetic ketosis capable of producing hemolysis. drugs or chemicals which have produced significant hemolysis in g6pd or methemoglobin reductase deficient patients include dapsone, sulfanilamide, nitrite, aniline, phenylhydrazine, naphthalene, niridazole, nitro-furantoin and 8-amino-antimalarials such as primaquine. toxic hepatitis and cholestatic jaundice have been reported early in therapy. hyperbilirubinemia may occur more often in g6pd deficient patients. when feasible, baseline and subsequent monitoring of liver function is recommended; if abnormal, dapsone should be discontinued until the source of the abnormality is
established.

Dosage and Administration:

Dosage and administration dermatitis herpetiformis the dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. if full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried. dosage should be reduced to a minimum maintenance level as soon as possible. in responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. there is no effect on the gastrointestinal component of the disease. dapsone levels are influenced by acetylation rates. patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage. a strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 ½ years and for dosage elimination 29 months with a range of 6 months to 9 years. lepro
sy in order to reduce secondary dapsone resistance, the who expert committee on leprosy and the usphs at carville, la, recommended that dapsone should be commenced in combination with one or more anti-leprosy drugs. in the multidrug program dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of dapsone monotherapy. for advice and other drugs, the usphs at carville, la (1-800-642-2477) should be contacted. before using other drugs consult appropriate product labeling. in bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of dapsone 100 mg daily with six months of rifampin 600 mg daily. under who, daily rifampin may be replaced by 600 mg rifampin monthly, if supervised. the dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months. then dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients. in lepromatous and borderline lepromatous patients, the recommendation is the co-administration of dapsone 100 mg daily with two years of rifampin 600 mg daily. under who daily rifampin may be replaced by 600 mg rifampin monthly, if supervised. one may elect the concurrent administration of a third anti-leprosy drug, usually either clofazimine 50 to 100 mg daily or ethionamide 250 to 500 mg daily. dapsone 100 mg daily is continued 3 to 10 years until all signs of clinical activity are controlled with skin scrapings and biopsies are negative for one year. dapsone should then be continued for an additional 10 years for borderline patients and for life for lepromatous patients. secondary dapsone resistance should be suspected whenever a lepromatous or borderline lepromatous patient receiving dapsone treatment relapses clinically and bacteriologically, solid staining bacilli being found in the smears taken from the new active lesions. if such cases show no response to regular and supervised dapsone therapy within three to six months or good compliance for the past 3 to 6 months can be assured, dapsone resistance should be considered confirmed clinically. determination of drug sensitivity using the mouse footpad method is recommended and, after prior arrangement, is available without charge from the usphs, carville, la. patients with proven dapsone resistance should be treated with other drugs.

Contraindications:

Contraindication hypersensitivity to dapsone and/or its derivatives.

Adverse Reactions:

Adverse reactions in addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on dapsone. hematologic effects dose-related hemolysis is the most common adverse effect and is seen in patients with or without g6pd deficiency. almost all patients demonstrate the inter-related changes of a loss or 1 to 2g of hemoglobin, an increase in the reticulocytes (2 to 12%), a shortened red cell life span and a rise in methemoglobin. g6pd deficient patients have greater responses. nervous system effects peripheral neuropathy is a definite but unusual complication of dapsone therapy in non-leprosy patients. motor loss is predominant. if muscle weakness appears, dapsone should be withdrawn. recovery on withdrawal is usually substantially complete. the mechanism of recovery is reported by axonal regeneration. some recovered patients have tolerated retreatment at reduced dosage. in leprosy this complication may be difficult to distinguish from a
leprosy reactional state. body as a whole in addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug induced lupus erythematosus and an infectious mononucleosis like syndrome. in general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.

Drug Interactions:

Drug interactions rifampin lowers dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions. a modest interaction has been reported for patients receiving 100 mg dapsone daily in combination with trimethoprim 5 mg/kg q6h. on day 7, serum dapsone levels averaged 2.1 ± 1.0 mcg/ml in comparison to 1.5 ± 0.5 mcg/ml for dapsone alone. on day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/ml in comparison to 12.4 ± 4.5 mcg/ml for patients not receiving dapsone. thus, there is a mutual interaction between dapsone and trimethoprim in which each raises the level of the other about 1.5 times. a crossover study 1 designed to assess the potential of a drug interaction between dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic hiv positive volunteers (average cd4 count 524 cells/mm 3 ) demonst
rated that there was not a significant drug interaction between dapsone and trimethoprim. however, an earlier report 2 also by lee et al, in 78 hiv infected patients with acute pneumocystis carinii pneumonia, receiving dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.

Use in Pregnancy:

Pregnancy teratogenic effects pregnancy category c animal reproduction studies have not been conducted with dapsone. extensive, but uncontrolled experience and two published surveys on the use of dapsone in pregnant women have not shown that dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. because of the lack of animal studies or controlled human experience, dapsone should be given to a pregnant woman only if clearly needed. in general, for leprosy, usphs at carville recommends maintenance of dapsone. dapsone has been important for the management of some pregnant d.h. patients.

Pediatric Use:

Pediatric use pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.

Overdosage:

Overdosage nausea, vomiting, hyperexcitability can appear a few minutes up to 24 hours after ingestion of an overdosage. methemoglobin induced depression, convulsions or severe cyanosis requires prompt treatment. in normal and methemoglobin reductase deficient patients, methylene blue, 1 to 2 mg/kg of body weight, given slowly intravenously, is the treatment of choice. the effect is complete in 30 minutes, but may have to be repeated if methemoglobin reaccumulates. for non-emergencies, if treatment is needed, methylene blue may be given orally in doses of 3 to 5 mg/kg every 4 to 6 hours. methylene blue reduction depends on g6pd and should not be given to fully expressed g6pd deficient patients.

Description:

Description dapsone-usp, 4,4'-diaminodiphenylsulfone (dds), is a primary treatment for dermatitis herpetiformis. it is an antibacterial drug for susceptible cases of leprosy. it is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils. dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. inactive ingredients: colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch. chemical structure

Clinical Pharmacology:

Clinical pharmacology actions the mechanism of action in dermatitis herpetiformis has not been established. by the kinetic method in mice, dapsone is bactericidal as well as bacteriostatic against mycobacterium leprae . absorption and excretion dapsone, when given orally, is rapidly and almost completely absorbed. about 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. excretion of the drug is slow and a constant blood level can be maintained with the usual dosage. blood levels detected a few minutes after ingestion, the drug reaches peak concentration in 4 to 8 hours. daily administration for at least eight days is necessary to achieve a plateau level. with doses of 200 mg daily, this level averaged 2.3 mcg/ml with a range of 0.1 to 7.0 mcg/ml the half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours. repeat tests in the same individual are constant. daily admini
stration (50 to 100 mg) in leprosy patients will provide blood levels in excess of the usual minimum inhibitory concentration even for patients with a short dapsone half-life.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis dapsone has been found carcinogenic (sarcomagenic) for male rats and female mice causing mesenchymal tumors in the spleen and peritoneum, and thyroid carcinoma in female rats. dapsone is not mutagenic with or without microsomal activation in s. typhimurium tester strains 1535, 1537, 1538, 98, or 100.

How Supplied:

How supplied dapsone tablets usp, 25 mg are available as round white to off-white scored tablets, debossed "25" above and "102" below the score and on the obverse "ncp" in bottles of 30 tablets. ndc 69543-150-30. dapsone tablets usp, 100 mg are available as round white to off-white scored tablets, debossed "100" above and "101" below the score and on the obverse "ncp" in bottles of 30 tablets. ndc 69543-151-30. store at 20°to 25° c (68°to 77°f). [see usp controlled room temperature]. protect from light. keep this and all medication out of the reach of children.

Package Label Principal Display Panel:

Principal display panel - 25 mg tablet bottle label ndc 43353-222-30 dapsone tablets, usp 25 mg 30 tablets rx only principal display panel - 25 mg tablet bottle label

Principal display panel - 100 mg tablet bottle label ndc 43353-223-30 dapsone tablets, usp 100 mg 30 tablets rx only principal display panel - 100 mg tablet bottle label


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