Drug: Aczone Gel
ACZONE Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE Gel (dapsone) , 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is: Each gram of ACZONE Gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer 980; diethylene glycol monoethyl ether, NF; methylparaben, NF; sodium hydroxide, NF; and purified water, USP.
Source: http://www.rxlist.com
Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Serious adverse reactions reported in patients treated with ACZONE Gel (dapsone) , 5%, during clinical trials included but were not limited to the following:
ACZONE
(N=1819) Vehicle
(N=1660) Application
Site Event Mild Moderate Severe Mild Moderate Severe Erythema 9% 5% < 1% 9% 6% < 1% Dryness 14% 3% < 1% 14% 4% < 1% Oiliness/ Peeling 13% 6% < 1% 15% 6% < 1% The adverse reactions occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 2. Table 2 : Adverse Reactions Occurring in at least 1% of Patients
ACZONE
N=1819 Vehicle
N=1660 Application Site Reaction NOS 18% 20% Application Site Dryness 16% 17% Application Site Erythema 13% 14% Application Site Burning 1% 2% Application Site Pruritus 1% 1% Pyrexia 1% 1% Nasopharyngitis 5% 6% Upper Respiratory Tract Inf. NOS 3% 3% Sinusitis NOS 2% 1% Influenza 1% 1% Pharyngitis 2% 2% Cough 2% 2% Joint Sprain 1% 1% Headache NOS 4% 4% NOS = Not otherwise specified One patient treated with ACZONE Gel (dapsone) in the clinical trials had facial swelling which led to discontinuation of medication. In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies. Experience with Oral Use of Dapsone Although not observed in the clinical trials with ACZONE Gel (topical dapsone) serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria). Read the Aczone Gel (dapsone) Side Effects Center for a complete guide to possible side effectsLearn More »
- Nervous system/Psychiatric - Suicide attempt, tonic clonic movements.
- Gastrointestinal - Abdominal pain, severe vomiting, pancreatitis.
- Other - Severe pharyngitis
ACZONE
(N=1819) Vehicle
(N=1660) Application
Site Event Mild Moderate Severe Mild Moderate Severe Erythema 9% 5% < 1% 9% 6% < 1% Dryness 14% 3% < 1% 14% 4% < 1% Oiliness/ Peeling 13% 6% < 1% 15% 6% < 1% The adverse reactions occurring in at least 1% of patients in either arm in the four vehicle controlled studies are presented in Table 2. Table 2 : Adverse Reactions Occurring in at least 1% of Patients
ACZONE
N=1819 Vehicle
N=1660 Application Site Reaction NOS 18% 20% Application Site Dryness 16% 17% Application Site Erythema 13% 14% Application Site Burning 1% 2% Application Site Pruritus 1% 1% Pyrexia 1% 1% Nasopharyngitis 5% 6% Upper Respiratory Tract Inf. NOS 3% 3% Sinusitis NOS 2% 1% Influenza 1% 1% Pharyngitis 2% 2% Cough 2% 2% Joint Sprain 1% 1% Headache NOS 4% 4% NOS = Not otherwise specified One patient treated with ACZONE Gel (dapsone) in the clinical trials had facial swelling which led to discontinuation of medication. In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study was consistent with that observed in the vehicle-controlled studies. Experience with Oral Use of Dapsone Although not observed in the clinical trials with ACZONE Gel (topical dapsone) serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria). Read the Aczone Gel (dapsone) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
For topical use only. Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel (dapsone) , 5%, in a thin layer to the acne affected areas twice daily. Rub in ACZONE Gel (dapsone) , 5%, gently and completely. ACZONE Gel (dapsone) , 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE Gel (dapsone) , 5%. If there is no improvement after 12 weeks, treatment with ACZONE Gel (dapsone) , 5%, should be reassessed.
Source: http://www.rxlist.com
Trimethoprim-Sulfomethoxazole A drug-drug interaction study evaluated the effect of the use of ACZONE Gel (dapsone) , 5%, in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged. However, levels of dapsone and its metabolites increased in the presence of TMP/SMX. Systemic exposure (AUC0-12) of dapsone and N-acetyl-dapsone (NAD) were increased by about 40% and 20% respectively in presence of TMP/SMX. Notably, systemic exposure (AUC0-12) of dapsone hydroxylamine (DHA) was more than doubled in the presence of TMP/SMX. Exposure from the proposed topical dose is about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX. Topical Benzoyl Peroxide Topical application of ACZONE Gel (dapsone) followed by benzoyl peroxide in subjects with acne vulgaris resulted in a temporary local yellow or orange discoloration of the skin and facial hair (reported by 7 out of 95 subjects in a clinical study) with resolution in 4 to 57 days. Drug Interactions with Oral Dapsone Certain concomitant medications (such as rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions. Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
ACZONE Gel (dapsone) , 5%, is indicated for the topical treatment of acne vulgaris.
Source: http://www.rxlist.com
None. Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
ACZONE Gel (dapsone) , 5%, is not for oral use. If oral ingestion occurs, medical advice should be sought.
Source: http://www.rxlist.com
Dosage Forms And Strengths ACZONE (dapsone) Gel, 5%, is supplied in the following size tubes:
3 gram laminate tube Commercially Available as: 5 % NDC XXXX-XXXX-XX........................Product Code 500530
30 gram laminate tube KEEP OUT OF THE REACH OF CHILDREN LESS THAN 12 YEARS OLD. Storage conditions: Store at controlled room temperature, 20-25°C (68-76°F), excursions permitted to 15-30ºC (59-86ºF). Protect from freezing. ACZONE™ (dapsone) Gel, 5% Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for QLT, USA, Inc., Fort Collins, CO 80525. FDA Rev date: 3/14/2008 Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
- Professional Sample: 3 gram laminate tube
- Commercially: 30 gram laminate tube
3 gram laminate tube Commercially Available as: 5 % NDC XXXX-XXXX-XX........................Product Code 500530
30 gram laminate tube KEEP OUT OF THE REACH OF CHILDREN LESS THAN 12 YEARS OLD. Storage conditions: Store at controlled room temperature, 20-25°C (68-76°F), excursions permitted to 15-30ºC (59-86ºF). Protect from freezing. ACZONE™ (dapsone) Gel, 5% Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for QLT, USA, Inc., Fort Collins, CO 80525. FDA Rev date: 3/14/2008 Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Hematological Effects Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern and Mediterranean ancestry. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE Gel (dapsone) , 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE Gel (dapsone) developed laboratory changes suggestive of mild hemolysis. If signs and symptoms suggestive of hemolytic anemia occur, ACZONE Gel (dapsone) , 5% should be discontinued. ACZONE Gel (dapsone) , 5% should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE Gel (dapsone) , 5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency. Peripheral Neuropathy Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical ACZONE Gel (dapsone) , 5% treatment. Skin Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical ACZONE Gel (dapsone) , 5% treatment. Patient Counseling Information See FDA Approved-Patient Labeling Information for Patients
ACZONE Vehicle N Mean N Mean Hemoglobin (g/dL) Pre-treatment 53 13.44 56 13.36 2 weeks 53 13.12 55 13.34 12 weeks 50 13.42 50 13.37 Bilirubin (mg/dL) Pre-treatment 54 0.58 56 0.55 2 weeks 53 0.65 55 0.56 12 weeks 50 0.61 50 0.62 Reticulocytes (%) Pre-treatment 53 1.30 55 1.34 2 weeks 53 1.51 55 1.34 12 weeks 50 1.48 50 1.41 There were no changes from baseline in haptoglobin or lactate dehydrogenase during ACZONE or vehicle treatment at either the 2-week or 12-week time point. The proportion of subjects who experienced decreases in hemoglobin ≥ 1 g/dL was similar between ACZONE Gel (dapsone) , 5% and vehicle treatment (8 of 58 subjects had such decreases during ACZONE treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). Subgroups based on gender, race, or G6PD enzyme activity did not display any differences in laboratory results from the overall study group. There was no evidence of clinically significant hemolytic anemia in this study. Some of these subjects developed laboratory changes suggestive of mild hemolysis. Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
- Patients should use ACZONE Gel (dapsone) , 5%, as directed by the physician. ACZONE Gel, 5%, is for external topical use only. ACZONE Gel (dapsone) , 5%, is not for oral, ophthalmic or intravaginal use.
- Patients should not use this medication for any disorder other than that for which it was prescribed.
- Patients should report any signs of adverse reactions to their physician.
- Protect ACZONE Gel (dapsone) , 5%, from freezing.
- See Patient Labeling for additional information on safety, efficacy, general use, and storage of ACZONE Gel (dapsone) , 5%.
ACZONE Vehicle N Mean N Mean Hemoglobin (g/dL) Pre-treatment 53 13.44 56 13.36 2 weeks 53 13.12 55 13.34 12 weeks 50 13.42 50 13.37 Bilirubin (mg/dL) Pre-treatment 54 0.58 56 0.55 2 weeks 53 0.65 55 0.56 12 weeks 50 0.61 50 0.62 Reticulocytes (%) Pre-treatment 53 1.30 55 1.34 2 weeks 53 1.51 55 1.34 12 weeks 50 1.48 50 1.41 There were no changes from baseline in haptoglobin or lactate dehydrogenase during ACZONE or vehicle treatment at either the 2-week or 12-week time point. The proportion of subjects who experienced decreases in hemoglobin ≥ 1 g/dL was similar between ACZONE Gel (dapsone) , 5% and vehicle treatment (8 of 58 subjects had such decreases during ACZONE treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). Subgroups based on gender, race, or G6PD enzyme activity did not display any differences in laboratory results from the overall study group. There was no evidence of clinically significant hemolytic anemia in this study. Some of these subjects developed laboratory changes suggestive of mild hemolysis. Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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