Dapsone - 7.5 (Aczone)

Trade Name : ACZONE

Allergan, Inc.

GEL

Strength 75 mg/g

DAPSONE Sulfone [EPC],Sulfones [CS]

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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 - 7.5 (Aczone) which is also known as ACZONE and Manufactured by Allergan, Inc.. It is available in strength of 75 mg/g per ml. Read more

Dapsone - 7.5 (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
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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, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas once daily. Rub in Gel, 7.5%, gently and completely.
If there is no improvement after 12 weeks, treatment with Gel, 7.5% should be reassessed ().
u2022 Apply once daily ().
u2022 Apply approximately a pea-sized amount of u00a0Gel, 7.5%, in a thin layer to the entire face. A thin layer can also be applied to other affected areas ().
u2022 If there is no improvement after 12 weeks, treatment with Gel, 7.5% should be reassessed ().
u2022 For topical use only. Not for oral, ophthalmic, or intravaginal use ().u00a0

Gel, 7.5%. Each gram of u00a0Gel, 7.5% contains 75u00a0mg of dapsone in an off-white to yellow gel with suspended particles.
Gel, 7.5% ().n

None.
None ().nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt

u2022 Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Gel if signs of methemoglobinemia occur ().
u2022 Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis ()().

Most common (incidence u2265 0.9%)u00a0adverse reactions are application site dryness and pruritusu00a0().

No formal drug-drug interaction studies were conducted withn Gel, 7.5%.
u2022 Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites ().
u2022 Topical benzoyl peroxide used at the same time as Gel, 7.5% may result in temporary local yellow or orange skin discoloration ().

No data

ACZONEn- ACZONE
Each gram of Gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether,u00a0methylparaben,u00a0acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.

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 340 times the systemic exposure observed in humans as a result of use of the MRHD of Gel, 7.5%, based on AUC comparisons).
No evidence of potential to induce carcinogenicity was 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 22 times the systemic exposure that is associated with the MRHD of Gel, 7.5%, 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 187 times the systemic exposure that is associated with the MRHD of Gel, 7.5%, 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 1407 times the systemic exposure that is associated with the MRHD of Gel, 7.5%, 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.

The safety and efficacy of once daily use of Gel, 7.5%, was assessed in two 12-week multicenter, randomized, double-blind, vehicle-controlled trials. Efficacy was assessed in a total of 4340 subjectsu00a012 years of age and older.u00a0The majority of the subjects had moderate acne vulgaris, 20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline,u00a0who were randomized to receive either Gel, 7.5% or vehicle.
Treatment response was defined at Week 12 as the proportion of subjects who were rated u201cnoneu201d or u201cminimalu201d with at least a two-grade improvement from baselineu00a0on the Global Acne Assessment Score (GAAS), and mean absolute change from baseline in both inflammatory and non-inflammatory lesion counts. A GAAS score of u201cnoneu201d corresponded to no evidence of facial acne vulgaris. A GAAS score of u201cminimalu201d corresponded to a few non-inflammatory lesions (comedones) being present and to a few inflammatory lesions (papules/pustules)u00a0that may be present.
The GAAS success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table.
Table n- 2n- .n- u00a0n- Clinical Efficacy of ACZONEn- Arrayn- Gel at Week 12 in Subjects with Acn- nn- e Vulgaris

ACZONE
ACZONE
nttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-5206-30nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt30 gram pump
nttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-5206-60nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt60 gram pump
nttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-5206-90nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt90 gram pump
Storage

Advise the patient to read the FDA-approved patient labeling ().
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. Patented. See: www.allergan.com/patents
v1.0USPI5206
-------Cut Hereu00a0----------------------------------------------------------------------------------------------------------------

This Patient Information has been approved by the U.S. Food and Drug Administration.nttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Issued: 05/2018

NDC 0023-5206-60Aczone(Dapsone)Get, 7.5%60 gRx Only

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Dapsone - 7.5 (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 - 7.5 (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?

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