Product Elements:
Dapsone dapsone dapsone dapsone magnesium stearate cellulose, microcrystalline starch, corn sodium lauryl sulfate stearic acid sodium starch glycolate type a white to off white r193
Indications and Usage:
Indications & 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 patient 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 shou
Read more...ld 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.
Dosage and Administration:
Dosage & 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 - 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 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years. leprosy:
Read more... 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 clofazamine 50-100 mg daily or ethionamide 250-500 mg daily. dapsone 100 mg daily is continued 3-10 years until all signs of clinical activity are controlled with skin scrapings and biopsies 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 3-6 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:
Contraindications 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 of 1-2g of hemoglobin, an increase in the reticulocytes (2-12%), 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 lepr
Read more...osy 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. to report suspected adverse reactions, contact rising pharmaceuticals, inc. at 1-866-562-4597 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
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, 1-2 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 3-5 mg/kg every 4-6 hours. methylene blue reduction depends on g6pd and should not be given to fully expressed g6pd deficient patients.
Description:
Description dapsone-usp, 4,4â-sulfonyl dianiline, is a primary treatment for dermatitis herpetiformis. it is an antibacterial drug for susceptible cases of leprosy. it is a white to creamy white crystalline powder, very slightly soluble in water, sparingly soluble in alcohol, soluble in acetone and dilute mineral acids. dapsone is issued on prescription in tablets of 100 mg for oral use. inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate (type a), and stearic acid. dapsone-struct
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 4-8 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 μg/ml with a range of 0.1-7.0 μg/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 adm
Read more...inistration (50 - 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.
How Supplied:
How supplied dapsone tablets usp, 100 mg are available as round, white to off-white, biconvex tablets debossed with r193 on one side and break line on other side. bottle of 100 tablets ndc 64980-566-01 store at 20°- 25° c (68°- 77°f). [see usp controlled room temperature]. protect from light. rx only. keep this and all drugs out of the reach of children.
Package Label Principal Display Panel:
Package label.principal display panel rising pharmaceuticals, inc. dapsone tablets, usp ndc 64980-566-01 100 mg (100 tablets) rx only dapsone-label-01