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Adapalene And Benzoyl Peroxide (Epiduo)

Trade Name : EPIDUO

Galderma Laboratories, L.P.

GEL

Strength 125 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) which is also known as EPIDUO and Manufactured by Galderma Laboratories, L.P.. It is available in strength of 1; 25 mg/g; mg/g per ml. Read more

Adapalene And Benzoyl Peroxide (Epiduo) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
  • EPIDUO gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ()
  • For topical use only; EPIDUO gel is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin film of EPIDUO 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 gel is not for oral, ophthalmic, or intravaginal use. () Apply a thin film of EPIDUO 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.u00a0()
  • Each gram of EPIDUO gel contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel.
  • Each gram of EPIDUO gel contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide.u00a0()
  • None
  • None. ()
  • Ultraviolet Light and Environmental Exposure:u00a0 Avoid exposure to sunlight and sunlamps.u00a0 Wear sunscreen when sun exposure cannot be avoided. ()
  • Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO gel and may necessitate discontinuation. ()
  • Most commonly reported adverse events (u22651%) in patients treated with EPIDUO gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation.u00a0()
  • To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137, or FDA at 1-800-FDA-1088 or n
  • 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 formal drug-drug interaction studies were conducted with EPIDUO gel.
  • No data
  • EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%.
  • Active: 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:
  • Array
  • 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:
  • Array
  • EPIDUO 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 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, and 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).u00a0 In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of EPIDUO gel. In the rat study, an increased incidence of benign and malignant pheochromocytomas 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 gel) for two years. Ratsu00a0received 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 the 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. However, 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, 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. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells.
  • In rat oral studies, 20 mg adapalene/kg/day (120 mg/m/day; 98 times the MRHD based on mg/m/day comparison) did not affect the reproductive performance and fertility of F males and females, or growth, development and reproductive function of F offspring.
  • No fertility studies were conducted with benzoyl peroxide.
  • The safety and efficacy of EPIDUO gel applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing EPIDUO gel to the gel vehicle in acne subjects.Treatment response was defined as the percent of subjects who had a two grade improvement and rated u2018Clearu2019 and u2018Almost Clearu2019 at Week 12 based on the Investigator's Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of 'Clear' corresponded to residual hyperpigmentation u00a0and erythema may be present. An IGA score of u2018Almost Clearu2019 corresponded to a few scattered comedones and a few small papules.In Study 1, 517 subjects were randomized to EPIDUO gel, adapalene 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of these 517 subjects was 15 years old and 60% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects had a baseline IGA score of u2018Moderateu2019 which corresponded to more than half of the face is involved, many comedones, papules and pustules. The efficacy results at week 12 are presented inu00a0Table 3.In Study 2, 1668 subjects were randomized to EPIDUO gel, adapalene 0.1%u00a0in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of subjects was 16 years old and 49% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions as well as an Investigator Global Assessment score of u2018Moderateu2019. The efficacy results at week 12 are presented in Table 3.In Study 3, 285 pediatric subjects 9 to 11 years of age were randomized to EPIDUO gel or vehicle gel. The median age of subjects was 11 years and 24% were males. At baseline, subjects had a minimum of 20 but not more than 100 total lesions (inflammatory and/or non-inflammatory) with an Investigator Global Assessment score of 'Moderate'. The efficacy results at week 12 are presented in Table 3.
  • In both Studies 1 and 2 the treatment effect was smaller in subjects with a small number of baseline lesions than in subjects with a large number of baseline lesions.
  • * -That is, a mean percent increase of 13.2%
  • EPIDUO (adapalene and benzoyl peroxide) gel 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:
  • 45 gram tube NDC 0299-5908-4545 gram pump NDC 0299-5908-25
  • Storage and handling
  • u00a0- Store at 25u00baC; excursions permitted to 15u00ba - 30u00baC (59u00ba - 86u00baF).
  • u00a0- Protect from light.
  • u00a0- Keep out of reach of children.
  • u00a0- Keep away from heat.
  • u00a0- Keep tube tightly closed.
  • [See FDA approved Patient Labeling (Patient Information)]
  • Information for Patients
  • - Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO gel as a thin layer, avoiding the eyes, lips and mucous membranes.
  • - 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.
  • - EPIDUO gel may cause irritation such as erythema, scaling, dryness, stinging or burning.
  • - Advise patients to minimize exposure to sunlight, including sunlamps.
  • - Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided.
  • - EPIDUO gel may bleach hair and colored fabric.
  • Patient Information EPIDUO (Ep-E-Do-Oh) (adapalene and benzoyl peroxide) gel 0.1%/2.5%
  • Important:
  • Read this Patient Information leaflet about EPIDUO gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about EPIDUO gel, talk with your doctor or pharmacist.
  • What is EPIDUO gel?
  • Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.
  • It is not known if EPIDUO gel is safe and effective in children younger than 9 years old.
  • What should I tell my doctor before using EPIDUO gel?
  • Tell your doctor about all the medicines you take,
  • Especially tell your doctor if you use any other medicine for acne. Using EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I use EPIDUO gel?
  • Applying EPIDUO gel:
  • What should I avoid while using EPIDUO gel?
  • What are the possible side effects of EPIDUO gel?
  • EPIDUO gel may cause serious side effects including:
  • 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 gel.
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of EPIDUO gel. For more information, ask your doctor or pharmacist.
  • 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 gel?
  • Keep EPIDUO gel and all medicines out of the reach of children.
  • General information about EPIDUO gel
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use EPIDUO gel for a condition for which it was not prescribed. Do not give EPIDUO gel to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about EPIDUO gel. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about EPIDUO gel that is written for health professionals.
  • What are the ingredients in EPIDUO gel?
  • Revised: January 2013
  • Marketed by:GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USAManufactured by:G Production Inc., Baie du2019Urfu00e9, QC, H9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.P51740-2
  • Rx OnlyNDC n- Epiduou00aen
  • For topical use only. Not for ophthalmic, oral or intravaginal use.n n Usual dosage: n- Each gram contains: n- Active:n- Inactive: n- Storage:
  • Marketed by:GALDERMA LABORATORIES, L.P.14501 North Freeway, Fort Worth, TX 76177 USAMade in Canada.u00a0All trademarks are the property of their respective owners.n n P51741-3n
  • No data
  • Epiduon n- FOR TOPICAL USE ONLYn NET WT. 45 gn NDC n- Rx onlyn
  • For topical use only. Not for ophthalmic, oral or intravaginal use.
  • Usual dosage:
  • Each gram contains Active:n- Inactive:
  • Storage:
  • Marketed by:GALDERMA LABORATORIES, L.P.14501 North Freeway, Fort Worth, TX 76177 USAn n P51359-3n Manufactured by:G Production Inc.Baie du2019Urfu00e9, QC, H9X 3S4 CanadaMade in Canada. Galderma is a registered trademark.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0

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