Dapsone (Aczone)

Trade Name : ACZONE

Allergan, Inc.

GEL

Strength 50 mg/g

DAPSONE Sulfone [EPC],Sulfones [CS]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dapsone (Aczone) which is also known as ACZONE and Manufactured by Allergan, Inc.. It is available in strength of 50 mg/g per ml. Read more

Dapsone (Aczone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

ACZONE
1

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 Gel, 5%, in a thin layer to the acne affected areas twice daily. Rub in Gel, 5%, gently andu00a0completely. Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of Gel, 5%.
If there is no improvement after 12 weeks, treatment with Gel, 5%, should be reassessed.
ACZONE
2

Apply twice daily ().n
Apply approximately a pea-sized amount of Gel, 5%,u00a0in a thin layer to the acne affected area ().n
If there is no improvement after 12 weeks, treatment withn
For topical use only. Not for oral, ophthalmic, or intravaginal use ().

Gel, 5%. Each gram of u00a0gel contains 50u00a0mg of dapsone in a white to pale yellow gel.
Gel, 5% ().

None.
None ().

No data

Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue gel if signs of methemoglobinemia occur ().u00a0n
Hematologic Effects:u00a0Someu00a0subjectsu00a0withu00a0G6PD deficiency usingu00a0u00a0Gelu00a0developedu00a0laboratoryu00a0changesu00a0suggestiveu00a0of hemolysis.u00a0()().

Most common adverse reactions (incidence u2265 10%) are oiliness/peeling,u00a0dryness andu00a0erythemau00a0atu00a0theu00a0applicationu00a0siteu00a0().

No data

Trimethoprim/sulfamethoxazoleu00a0(TMP/SMX)u00a0increasesu00a0theu00a0levelu00a0ofu00a0dapsoneu00a0andu00a0itsu00a0metabolitesu00a0().n
Topical benzoyl peroxide used at the same time as u00a0mayu00a0resultu00a0inu00a0temporaryu00a0localu00a0yellowu00a0oru00a0orangeu00a0skinu00a0discolorationu00a0().

No data

ACZONEn- ACZONE
Each gram of Gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C; diethylene glycol monoethyl ether, NF; methylparaben, NF; sodium hydroxide, NF; and purified water, USP.

No data

Dapsone was not carcinogenic to rats when orally administered to females for 92 weeks or males for 100 weeks at dose levels up to 15 mg/kg/day (approximately 231 times the systemic exposure observed in humans as a result of use of the MRHD of Gel, 5%, based on AUC comparisons).
No evidence of potential to induce carcinogenesisu00a0was observed in a dermal study in which dapsone gel was topically applied to Tg.AC transgenic mice for approximately 26 weeks. Dapsone concentrations of 3%, 5%, and 10% were evaluated; 3% material was judged to be the maximum tolerated dosage.
Dapsone was negative in a bacterial reverse mutation assay (Ames test), and was negative in a micronucleus assay conducted in mice. Dapsone was positive (clastogenic) in a chromosome aberration assay conducted with Chinese hamster ovary (CHO) cells.
The effects of dapsone on fertility and general reproductive performance were assessed in male and female rats following oral dosing. Dapsone reduced sperm motility at dosages of 3 mg/kg/day or greater (approximately 15 times the systemic exposure that is associated with the MRHD of Gel, 5%, based on AUC comparisons) when administered daily beginning 63 days prior to mating and continuing through the mating period. The mean numbers of embryo implantations and viable embryos were significantly reduced in untreated females mated with males that had been dosed at 12 mg/kg/day or greater (approximately 127 times the systemic exposure that is associated with the MRHD of Gel, 5%, based on AUC comparisons), presumably due to reduced numbers or effectiveness of sperm, indicating impairment of fertility. When administered to female rats at a dosage of 75 mg/kg/day (approximately 956 times the systemic exposure that is associated with the MRHD of Gel, 5%, based on AUC comparisons) for 15 days prior to mating and for 17 days thereafter, dapsone reduced the mean number of implantations, increased the mean early resorption rate, and reduced the mean litter size. These effects probably were secondary to maternal toxicity.

Two randomized, double-blind, vehicle-controlled, clinical trials were conducted to evaluate Gel, 5%, for the treatment of subjects with acne vulgaris (N=1475 and 1525). The trials were designed to enroll subjects 12 years of age and older with 20 to 50 inflammatory and 20 to 100 non-inflammatory lesions at baseline. In these trials, subjects applied either Gel, 5%, or vehicle control twice daily for up to 12 weeks. Efficacy was evaluated in terms of success on the Global Acne Assessment Score (no or minimal acne) and in the percent reduction in inflammatory, non-inflammatory, and total lesions.
The Global Acne Assessment Score was a 5-point scale as follows:
0 None: no evidence of facial acne vulgaris
1 Minimal: few non-inflammatory lesions (comedones) are present; a few inflammatory lesions
(papules/pustules) may be present
2 Mild: several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions
(papules/pustules) are present
3 Moderate: many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no
nodulo-cystic lesions are allowed
4 Severe: significant degree of inflammatory disease; papules/pustules are a predominant feature; a few
u00a0u00a0u00a0u00a0u00a0nodulo-cystic lesions may be present; comedones may be present.
The success rates on the Global Acne Assessment Score (no or minimal acne) at Week 12 are presented in Table 4.
nttu00a0u00a0u00a0u00a0u00a0nt*Analysis excludes subjects classified with minimal acne at baseline
Table 5 presents the mean percent reduction in inflammatory, non-inflammatory, and total lesions from baseline to Week 12.
The clinical trials enrolled about equal proportions of male and female subjects. Female subjects tended to have greater percent reductions in lesions and greater success on the Global Acne Assessmentu00a0Score than males. The breakdown by race in the clinical trials was about 73% Caucasian, 14% Black, 9% Hispanic, and 2% Asian. Efficacy results were similar across the racial subgroups.

ACZONE
NDC 0023-3670-30
30 gram laminate tube
NDC 0023-3670-60
60 gram laminate tube
NDC 0023-3670-90
90 gram laminate tube
Store gel at controlled room temperature, 20u00b0-25u00b0C (68u00b0-77u00b0F), excursions permitted to 15u00b0-30u00baC (59u00b0-86u00baF). Protect from freezing.

Advise the patient to read theu00a0FDA-approved patient labeling (Patient Information).u00a0
Hematological Effects
Important Administration Instructions
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
u00a9 2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
v1.0USPI3670
-------Cut Here ----------------------------------------------------------------------------------------------------------------

This Patient Information has been approved by the U.S. Food and Drug Administration.nttu00a0u00a0u00a0u00a0u00a0ntRevised: 05/2018

NDC 0023-3670-90Aczone(dapsone)gel, 5%90 gRx Only

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Dapsone (Aczone)

Trade Name : ACZONE

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Dapsone (Aczone)

Trade Name : ACZONE

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?