Dapsone (Page 2 of 2)

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 If muscle weakness appears, Dapsone should be withdrawn.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 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.

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.

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 50-300 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: 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.

LEPROSY REACTIONAL STATES

Abrupt changes in clinical activity occur in leprosy with any effective treatment and are known as reactional states. The majority can be classified into two groups.

The “Reversal” reaction (Type 1) may occur in borderline or tuberculoid leprosy patients often soon after chemotherapy is started. The mechanism is presumed to result from a reduction in the antigenic load: the patient is able to mount an enhanced delayed hypersensitivity response to residual infection leading to swelling (“Reversal”) of existing skin and nerve lesions. If severe, or if neuritis is present, large doses of steroids should always be used. If severe, the patient should be hospitalized. In general anti-leprosy treatment is continued and therapy to suppress the reaction is indicated such as analgesics, steroids, or surgical decompression of swollen nerve trunks. USPHS at Carville, LA should be contacted for advice in management.

Erythema nodosum leprosum (ENL) (lepromatous reaction) (Type 2 reaction) occurs mainly in lepromatous patients and small numbers of borderline patients. Approximately 50% of treated patients show this reaction in the first year. The principal clinical features are fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. Skin lesions can become pustular and/or ulcerate. Histologically there is a vasculitis with an intense polymorphonuclear infiltrate. Elevated circulating immune complexes are considered to be the mechanism of reaction. If severe, patients should be hospitalized. In general, anti-leprosy treatment is continued. Analgesics, steroids, and other agents available from USPHS, Carville, LA, are used to suppress the reaction.

HOW SUPPLIED

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed “25” above and “102” below the score and on the obverse “JACOBUS” in:

  • Unit of Use carton of 30 tablets (2 x 15). The blisters are light and child-resistant. NDC 13925-504-30.
  • light and child-resistant bottles of 100, NDC 49938-102-01.

Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed “100” above and “101” below the score and on the obverse “JACOBUS” in:

  • Unit of Use carton of 30 tablets (2 x 15).The blisters are light and child-resistant. NDC 13925-505-30.
  • light and child-resistant bottles of 100, NDC 49938-101-01.

REFERENCES

  1. Lee, B., et al., Zidovudine, Trimethoprim, and Dapsone Pharmacokinetic Interactions in Patients with HIV Infection. Antimicrobial Agents and Chemotherapy , May 1996; 1231-1236.
  2. Lee, B., et al., Dapsone, Trimethoprim, and Sulfamethoxazole Plasma Levels During Treatment of Pneumocystis Carinii Pneumonia in Patients with AIDS, Annals of Internal Medicine , 1989; 110:606-611.

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.

Manufactured By:
Jacobus Pharmaceutical Company, Inc.
Princeton, New Jersey 08540
Tel: 609-921-7447

Distributed By:
Seton Pharmaceuticals
Manasquan, NJ 08736 U.S.A
Tel: 800-510-3401

Revised February 2016

0206S116

Principal Display Panel — Label 25 mg 30 count

Contains 12: NDC 13925-504-30

Dapsone
Tablets USP 25 mg

12 cartons each containing

30 tablets ( 2 x 15 unit of use)

Store at 20° to 25° C (68° to 77°) [See USP Controlled Room Temperature]

Protect From Light

image description
(click image for full-size original)

Principal Display Panel — Label 25 mg 100 count

NDC 13925-504-01

DAPSONE
Tablets, USP

25 mg

100 tablets

Caution: Federal law prohibits dispensing
without prescription. Dispense this product
in a well closed, light-resistant containerwith child resistant closure.

image description
(click image for full-size original)

Principal Display Panel — 100 mg 30 count

Contains 12: NDC 13925-505-30

Dapsone
Tablets USP 100 mg

12 cartons each containing

30 Tablets (2 x 15 unit of use)

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Protect From Light

image description
(click image for full-size original)

Principal Display Panel — 100 mg 30 count

NDC 13925-505-01

DAPSONE
Tablets, USP

100 mg

100 tablets

Caution: Federal law prohibits dispensing
without prescription. Dispense this product
in a well closed, light-resistant containerwith child resistant closure.

image description
(click image for full-size original)
DAPSONE dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (DAPSONE) DAPSONE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code 25;102;JACOBUS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13925-504-30 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 15 TABLET in 1 BLISTER PACK This package is contained within the CARTON (13925-504-30)
2 NDC:13925-504-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086841 03/04/2016
DAPSONE dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-505
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dapsone (Dapsone) Dapsone 100 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
Starch, Corn
SILICON DIOXIDE
Magnesium Stearate
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 100;101;JACOBUS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13925-505-30 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 15 TABLET in 1 BLISTER PACK This package is contained within the CARTON (13925-505-30)
2 NDC:13925-505-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086842 03/10/2016
Labeler — Seton Pharmaceuticals (828898002)
Registrant — Seton Pharmaceuticals (828898002)
Establishment
Name Address ID/FEI Operations
Jacobus Pharmaceutical Co. Inc. 088805734 manufacture (13925-504), manufacture (13925-505)

Revised: 04/2020 Seton Pharmaceuticals

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