Adapalene (Adapalene)

Trade Name : Adapalene

Sandoz Inc.

GEL

Strength 3 mg/g

ADAPALENE 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 (Adapalene) which is also known as Adapalene and Manufactured by Sandoz Inc.. It is available in strength of 3 mg/g per ml. Read more

Adapalene (Adapalene) 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 Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. n
  • Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
  • Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.u00a0 Avoid application to the areas of skin around eyes, lips, and mucous membranes.u00a0 A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel, 0.3%.u00a0 Patients should be instructed to minimize sun exposure.u00a0 Patients may be instructed to use moisturizers for relief of dry skin or irritation.
  • If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.
  • For topical use only.u00a0 Not for ophthalmic, oral or intravaginal use.
  • Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.
  • For topical use only. Not for ophthalmic, oral or intravaginal use.
  • Each gram of Adapalene Gel USP, 0.3% contains 3 mg adapalene in an off-white aqueous gel.
  • Each gram of Adapalene Gel USP, 0.3% contains 3 mg adapalene in an off-white aqueous gel.
  • Adapalene gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle.
  • Adapalene gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle.
  • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided . Erythema, scaling, dryness, and stinging/burning were reported with use ofu00a0 adapalene gel .
  • The most frequently reported (u22651%) adverse reactions were dry skin, skin discomfort, pruritus, desquamation, and sunburn. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n
  • 7.1 Concomitant Topical Medications
  • As adapalene gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.u00a0 Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with adapalene gel, 0.3%, until the effects of such preparations have subsided.
  • No formal drug-drug interaction studies were conducted with adapalene gel, 0.3%.
  • As adapalene gel has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Use with caution, especially when using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene gel.
  • No data
  • Adapalene gel, 0.3% is intended for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur.u00a0 Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.
  • Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide.u00a0 May contain hydrochloric acid for pH adjustment.
  • The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is CHO and molecular weight is 412.53.u00a0 Adapalene is represented by the following structural formula.
  • No data
  • Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day.u00a0 These doses are up to 3 times (mice) and 2 times (rats) in terms of mg/mu00b2/day the potential exposure at the maximum recommended human dose (MRHD), assumed to be 2.5 grams adapalene gel, 0.3%. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.
  • No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight.u00a0 Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.
  • Adapalene did not exhibit mutagenic or genotoxic effects (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) and (mouse micronucleus test).
  • Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 26 times the MRHD based on mg/mu00b2 comparisons).u00a0 No effects of adapalene were found on the reproductive performance or fertility of the F males or females.u00a0 There were also no detectable effects on the growth, development and subsequent reproductive function of the F offspring.
  • The safety and efficacy of once daily use of adapalene gel, 0.3% for treatment of acne vulgaris were assessed in one 12 week, multi-center, controlled, clinical study, conducted in a total of 653 patients 12 to 52 years of age with acne vulgaris of mild to moderate severity.u00a0 All female patients of child-bearing potential enrolled in the study were required to have a negative urine pregnancy test at the beginning of the study and were required to practice a highly effective method of contraception during the study. Female patients who were pregnant, nursing or planning to become pregnant were excluded from the study.
  • Patients enrolled in the study were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%).u00a0 An equal number of males (49.5%) and females (50.5%) enrolled. Success was defined as u201cClearu201d or u201cAlmost Clearu201d in the Investigatoru2019s Global Assessment (IGA).u00a0 The 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 3: Clinical study primary efficacy results at Week 12
  • Adapalene Gel USP, 0.3% is supplied in the following size. 45 g tube u2013 NDC 0781-7142-1945 g pump - NDC 0781-7142-70
  • Arrayn- Storage:
  • u201cSee FDA-approved patient labeling (Patient Information)u201d
  • Information for Patients
  • Patients using adapalene gel, 0.3%, should receive the following information and instructions:
  • Manufactured byTOLMAR Inc.Fort Collins, CO 80526 forSandoz Inc.Princeton, NJ 08540
  • 44457 Rev. 3 07/16
  • Patient Informationn n- Adapalene Gel, 0.3%n
  • Important:
  • Read this Patient Information that comes with Adapalene Gel, 0.3% 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 Gel, 0.3%, talk with your doctor or pharmacist.
  • What is Adapalene Gel, 0.3%?
  • Adapalene Gel, 0.3% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 12 years of age and older.
  • Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.
  • It is not known if Adapalene Gel, 0.3% is safe and effective in children younger than 12 years of age or in people 65 years of age and older.
  • Who should not use Adapalene Gel, 0.3%?
  • Do not use Adapalene Gel, 0.3% if you:
  • u25cfttare allergic to adapalene or any of the ingredients in Adapalene Gel, 0.3%. See the end of this Patient Information for a complete list of ingredients in Adapalene Gel.
  • What should I tell my doctor before using Adapalene Gel, 0.3%?
  • Before you use Adapalene Gel, 0.3%, 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 Gel, 0.3% 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 Adapalene Gel, 0.3%?
  • Applying Adapalene Gel, 0.3%:
  • What should I avoid while using Adapalene Gel, 0.3%?
  • What are the possible side effects of Adapalene Gel, 0.3%?
  • Adapalene Gel, 0.3% may cause serious side effects including:
  • You may use a moisturizer for relief of dry skin or irritation, however you should avoid products that contain alpha hydroxy or glycolic acid.
  • The most common side effects of Adapalene Gel, 0.3% are:
  • 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 Adapalene Gel, 0.3%. 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 Sandoz Inc. at 1-800-525-8747.
  • How should I store Adapalene Gel, 0.3%?
  • Keep Adapalene Gel, 0.3% and all medicines out of the reach of children.
  • General information about Adapalene Gel, 0.3%
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Adapalene Gel, 0.3% for a condition for which it was not prescribed. Do not give Adapalene Gel, 0.3% 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 Gel, 0.3%. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Adapalene Gel, 0.3% that is written for health professionals.
  • What are the ingredients in Adapalene Gel, 0.3%?
  • Active ingredient: adapalene
  • Inactive ingredients: carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid for pH adjustment.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured by TOLMAR Inc.Fort Collins, CO 80526 forSandoz Inc.Princeton, NJ 0854044457 Rev. 3 07/16
  • No data

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