Adapalene And Benzoyl Peroxide (Epiduo Forte)

Trade Name : epiduo forte

Galderma Laboratories, L.P.

GEL

Strength 325 mg/gmg/g

ADAPALENE; BENZOYL PEROXIDE Retinoid [EPC],Retinoids [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 Adapalene And Benzoyl Peroxide (Epiduo Forte) which is also known as epiduo forte and Manufactured by Galderma Laboratories, L.P.. It is available in strength of 3; 25 mg/g; mg/g per ml. Read more

Adapalene And Benzoyl Peroxide (Epiduo Forte) 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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About GNH

No data

EPIDUO FORTE gel is indicated for the topical treatment of acne vulgaris.
EPIDUO FORTE gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris.

For topical use only. EPIDUO FORTE gel is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer of EPIDUO FORTE gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes.
EPIDUO FORTE gel is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer of EPIDUO FORTE gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips, and mucous membranes.

Each gram of EPIDUO FORTE gel contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque gel. EPIDUO FORTE is available in pumps containing 15 g, 30 g, 45 g, 60 g or 70 g.
Gel, 0.3%/2.5% in 15-g, 30-g, 45-g, 60-g and 70-g pumps

None.
None

u2022 Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. ()u2022 Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO FORTE gel and may necessitate discontinuation. ()

Most commonly reported adverse reactions (u22651%) in patients treated with EPIDUO FORTE gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation. n

No formal drug-drug interaction studies were conducted with EPIDUO FORTE gel.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

No data

EPIDUO FORTE (adapalene and benzoyl peroxide) gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:
Adapalene:
Molecular formula: CHO Molecular weight: 412.5
Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:
Benzoyl Peroxide:
Molecular formula: CHO Molecular weight: 242.23
EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

No data

No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with EPIDUO FORTE gel.
Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, 12 mg/m/day), and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m/day). In terms of body surface area, the highest dose levels are 3.2 (mice) and 2.4 (rats) the MRHD of 2 grams of EPIDUO FORTE gel. In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed.
No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in EPIDUO FORTE gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg. In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 year study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years.
The role of benzoyl peroxide as a tumor promoter has been well established in several animal species. The significance of this finding in humans is unknown.
In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks.
No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources.
Adapalene did not exhibit mutagenic or genotoxic effects (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or (mouse micronucleus test).
Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results; mutagenic potential was observed in a few but not in a majority of investigations. It has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, caused DNA-protein cross-links in the human cells, and also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells.
In rat oral studies, 20 mg adapalene/kg/day did not affect the reproductive performance and fertility of F males and females, or the growth, development and reproductive function of F offspring.
No fertility studies were conducted with benzoyl peroxide.

The safety and efficacy of EPIDUO FORTE gel applied once daily for 12 weeks for the treatment of acne vulgaris were assessed in a multicenter, randomized, double-blind, vehicle-controlled study, comparing EPIDUO FORTE gel to vehicle gel in subjects with acne vulgaris. The study also evaluated adapalene and benzoyl peroxide gel, 0.1%/2.5%, a lower strength product than EPIDUO FORTE (adapalene and benzoyl peroxide) gel, 0.3%/2.5%. In this study, 217 subjects were treated with EPIDUO FORTE gel, 217 subjects with adapalene and benzoyl peroxide, gel, 0.1%/2.5% and 69 subjects with the vehicle gel.
Treatment response was defined as the percent of subjects who were rated u201cclearu201d or u201calmost clearu201d at Week 12 with at least a two-grade improvement based on the Investigatoru2019s Global Assessment (IGA), and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of u2018Clearu2019 corresponded to clear skin with no inflammatory or non-inflammatory lesions. An IGA score of u201calmost clearu201d corresponded to a few scattered comedones and a few small papules.
At baseline, 50% of subjects were graded as u201cmoderateu201d (IGA Grade 3) and 50% were graded as u201csevereu201d (IGA Grade 4) on the IGA scale. Subjects had an average of 98 (range 51-226) total lesions of which the mean number of inflammatory lesions was 38 (range: 20-99) and the mean number of non-inflammatory lesions was 60 (range 30-149). Subjects ranged in age from 12 to 57 years, with 273 (54%) of subjects 12 to 17 years of age. Approximately equal number of males (48%) and females (52%) were enrolled.
The IGA success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table.
* This study was not designed or powered to compare the efficacy of EPIDUO FORTE to the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5%, nor to compare the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5% to the vehicle control.
In subjects graded as u201csevereu201d (IGA Grade 4), efficacy was observed in the EPIDUO FORTE group.

EPIDUO FORTE (adapalene and benzoyl peroxide) gel 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:
15 gram pump NDC 0299-5906-1530 gram pump NDC 0299-5906-3045 gram pump NDC 0299-5906-4560 gram pump NDC 0299-5906-6070 gram pump NDC 0299-5906-70
Storage and handlingu2022 Store at controlled room temperature 20u201325u00b0C (68u201377u00b0F) with excursions permitted to 15u00b0u201330u00b0C (59u00b0u201386u00b0F) [see USP controlled room temperature].u2022 Protect from light.u2022 Keep out of reach of children.u2022 Keep away from heat.

[See FDA Approved Patient Labeling (Patient Information)]
Information for Patientsu2022 Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO FORTE gel as a thin layer, avoiding the eyes, lips and mucous membranes.u2022 Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation.u2022 EPIDUO FORTE gel may cause irritation such as erythema, scaling, dryness, stinging or burning.u2022 Advise patients to minimize exposure to sunlight, including sunlamps.u2022 Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.u2022 EPIDUO FORTE gel may bleach hair and colored fabric.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA
GALDERMA is a registered trademark.P52751-0

Patient informationEPIDUO FORTE (Ep-E-Do-Oh For-Tay)(adapalene and benzoyl peroxide)gel 0.3%/2.5%
Important Information:
What is EPIDUO FORTE gel?
Before using EPIDUO FORTE gel, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using other topical acne products may increase the irritation of your skin when used with EPIDUO FORTE gel.
How should I use EPIDUO FORTE gel?
Applying EPIDUO FORTE gel:
What should I avoid while using EPIDUO FORTE gel?
What are the possible side effects of EPIDUO FORTE gel?
EPIDUO FORTE gel may cause serious side effects including:
Local skin reactions.
Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using EPIDUO FORTE gel.
These are not all the possible side effects of EPIDUO FORTE gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to GALDERMA LABORATORIES, L.P. at 1-866-735-4137
How should I store EPIDUO FORTE gel?
Keep EPIDUO FORTE gel and all medicines out of the reach of children.
General information about the safe and effective use of EPIDUO FORTE gel
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPIDUO FORTE gel for a condition for which it was not prescribed. Do not give EPIDUO FORTE gel to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about EPIDUO FORTE gel that is written for health professionals.
What are the ingredients in EPIDUO FORTE gel?
Active ingredient:
Inactive ingredients:
Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USAGALDERMA is a registered trademark. P52751-0
This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 07/2015

Rx only NDC 0299-5906-45
EPIDUOFORTE
(adapalene and benzoyl peroxide) Gel 0.3%/2.5%
PUMP
FOR TOPICAL USE ONLY
NET WT.
45 g
GALDERMA
For topical use only. Not for ophthalmic, oral or intravaginal use.
Usual dosage:
Each gram contains: Active:n- Inactive:
Storage:
See carton closure for lot number and expiration date.
Marketed by:
GALDERMA LABORATORIES, L.P.
14501 North Freeway
Fort Worth, Texas 76177 USA
Made in Canada.
All trademarks are the property of their respective owners
www.epiduoforte.com
P52750-1

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Adapalene And Benzoyl Peroxide (Epiduo Forte)

Trade Name : epiduo forte

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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Adapalene And Benzoyl Peroxide (Epiduo Forte)

Trade Name : epiduo forte

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)

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