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Adapalene And Benzoyl Peroxide (Adapalene And Benzoyl Peroxide)

Trade Name : Adapalene and Benzoyl Peroxide

Sandoz Inc.

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 (Adapalene And Benzoyl Peroxide) which is also known as Adapalene and Benzoyl Peroxide and Manufactured by Sandoz Inc.. It is available in strength of 1; 25 mg/g; mg/g per ml. Read more

Adapalene And Benzoyl Peroxide (Adapalene And Benzoyl Peroxide) 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
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% 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; adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% 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.
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% is not for oral, ophthalmic, or intravaginal use. ()
  • Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide. ()
  • None
  • None. ()
  • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. () Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of adapalene and benzoyl peroxide gel 0.1% / 2.5% and may necessitate discontinuation. ()
  • Most commonly reported adverse events (u22651%) in patients treated with adapalene and benzoyl peroxide gel 0.1% / 2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .
  • 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%.
  • No data
  • 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%.
  • 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:n
  • Adapalene:
  • Molecular formula: CHOu00a0u00a0u00a0u00a0u00a0 Molecular weight: 412.5u00a0u00a0u00a0u00a0u00a0u00a0
  • 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:u00a0
  • Benzoyl Peroxide:
  • Molecular formula: CHOu00a0u00a0u00a0u00a0u00a0 Molecular weight: 242.23
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.u00a0
  • No data
  • No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide gel 0.1% / 2.5%.
  • 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). 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%. 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 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide gel 0.1% / 2.5%) 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 to 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 Fmales and females, or growth, development and reproductive function of F offspring.
  • No fertility studies were conducted with benzoyl peroxide.
  • The safety and efficacy of adapalene and benzoyl peroxide gel 0.1% / 2.5% applied once daily for the treatment of acne vulgaris were assessed in two 12 week, multicenter, controlled clinical studies of similar design, comparing adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 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 residual hyperpigmentation and 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%, 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.n
  • 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 in .n
  • In Study 2, 1668 subjects were randomized to adapalene and benzoyl peroxide gel 0.1% / 2.5%, adapalene 0.1% in 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 Globaln
  • Assessment score of u2018Moderateu2019. The efficacy results at week 12 are presented in .
  • In Study 3, 285 pediatric subjects 9 to 11 years of age were randomized to adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 u2018Moderateu2019. The efficacy results at week 12 are presented in .n
  • Table 3: Clinical Efficacy of n- Adapalene and Benzoyl Peroxide Gel 0.1% / 2.5% n- at Week 12
  • 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.
  • 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:
  • u00a0 u00a0 u00a045 gram tubeu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0781-7182-19u00a0 u00a0 u00a045 gram pumpu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0781-7182-70
  • Storage and handling
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Information for Patientsn
  • Manufactured by:TOLMAR Inc.Fort Collins, CO 80526 forSandoz Inc.Princeton NJ 08540
  • 04005028 Rev. 0 03/18n
  • Adapalene (a dap' a leen) and Benzoyl (ben' zoe il) Peroxide Gel 0.1% / 2.5%
  • Important:
  • Read this Patient Information leaflet about adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%, talk with your doctor or pharmacist.n
  • What is n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.
  • Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.n
  • It is not known if adapalene and benzoyl peroxide gel 0.1% / 2.5% is safe and effective in children younger than 9 years old.n
  • What should I tell my doctor before using n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Before you use adapalene and benzoyl peroxide gel 0.1% / 2.5%, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • Especially tell your doctor if you use any other medicine for acne. Using adapalene and benzoyl peroxide gel 0.1% / 2.5% with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.n
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.n
  • How should I use n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Applying n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- :
  • What should I avoid while using n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • What are the possible side effects of n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%.
  • Tell your doctor if you have any side effect that bothers you or that does not go away.n
  • These are not all the possible side effects of adapalene and benzoyl peroxide gel 0.1% / 2.5%. For more information, ask your doctor or pharmacist.n
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
  • You may also report side effects to Sandoz Inc. at 1-800-525-8747.
  • How should I store n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Keep n- adapalene and benzoyl peroxide gel 0.1% / 2.5% n- and all medicines out of the reach of children.
  • General information about n- adapalene and benzoyl peroxide gel 0.1% / 2.5%
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use adapalene and benzoyl peroxide gel 0.1% / 2.5% for a condition for which it was not prescribed. Do not give adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about adapalene and benzoyl peroxide gel 0.1% / 2.5% that is written for health professionals.n
  • What are the ingredients in n- adapalene and benzoyl peroxide gel 0.1% / 2.5%n- ?
  • Active ingredient: adapalene and benzoyl peroxide
  • Inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.
  • Manufactured by:TOLMAR Inc., Fort Collins, CO 80526 forSandoz Inc., Princeton NJ 08540
  • 04005028 Rev. 0 03/18n
  • No data

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