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| Product NDC Code | 51672-1377 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Adapalene |
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| Type | Generic | ||||||
| Pharm Class | Retinoid [EPC], Retinoids [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 722111 | ||||||
| Application Number | ANDA208322 | ||||||
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. | ||||||
| Packages |
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Overdosage of Adapalene
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene Gel, 0.3% once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with Adapalene Gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel, 0.3% Incidence of Local Cutaneous Irritation with Adapalene Gel, 0.3% (N = 253 Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. ) Maximum Severity Scores Higher Than Baseline Mild Moderate Severe Erythema 66 (26.1%) 33 (13%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel, 0.3% Adapalene Gel, 0.3% Vehicle Gel N=258 N=134 Related Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adverse Reactions 57 (22.1%) 6 (4.5%) Dry Skin 36 (14%) 2 (1.5%) Skin Discomfort 15 (5.8%) 0 (0%) Desquamation 4 (1.6%) 0 (0%) The following adverse reactions occurred in less than 1% of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema. In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
| Mild | Moderate | Severe | |
|---|---|---|---|
| Erythema | 66 (26.1%) | 33 (13%) | 1 (0.4%) |
| Scaling | 110 (43.5%) | 47 (18.6%) | 3 (1.2%) |
| Dryness | 113 (44.7%) | 43 (17%) | 2 (0.8%) |
| Burning/Stinging | 72 (28.5%) | 36 (14.2%) | 9 (3.6%) |
| Adapalene Gel, 0.3% | Vehicle Gel | |
|---|---|---|
| N=258 | N=134 | |
| Related | 57 (22.1%) | 6 (4.5%) |
| Dry Skin | 36 (14%) | 2 (1.5%) |
| Skin Discomfort | 15 (5.8%) | 0 (0%) |
| Desquamation | 4 (1.6%) | 0 (0%) |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. 12.2 Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel, 0.3%. 12.3 Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel, 0.3% was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of Adapalene Gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max of 0.553 ± 0.466 ng/mL on Day 10 of treatment. The mean AUC 0-24hr was 8.37 ± 8.46 ng∙h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject. Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene Gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks. Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ = 0.25 ng/mL) of the method were found. One of these samples was taken at Week 12 from a male subject treated with Adapalene Gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel, 0.3%.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel, 0.3% was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of Adapalene Gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max of 0.553 ± 0.466 ng/mL on Day 10 of treatment. The mean AUC 0-24hr was 8.37 ± 8.46 ng∙h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject. Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene Gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks. Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ = 0.25 ng/mL) of the method were found. One of these samples was taken at Week 12 from a male subject treated with Adapalene Gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS Adapalene Gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ] . Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3%. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Adapalene Gel, 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 homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. 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 C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. 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. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Gel, 0.3%. Instruct patients to minimize sun exposure and 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. Not for ophthalmic, oral or intravaginal use. Wash affected areas gently with a non-medicated soap. ( 2 ) Apply a thin film of Adapalene Gel, 0.3% to the entire face and other affected areas of the skin once daily in the evening. ( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. Gel, 0.3% ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Adapalene Adapalene CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM METHYLPARABEN POLOXAMER 182 PROPYLENE GLYCOL WATER SODIUM HYDROXIDE ADAPALENE ADAPALENE white to off-white
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene Gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison. In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene Gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison. In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 45 g Bottle Carton 45 g NDC 51672-1377-9 Adapalene Gel 0.3% PUMP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 45 g Bottle Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532 Revised: 6/2024 5251769 28
Adapalene: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene Gel, 0.3% should receive the following information and instructions: 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. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. Wax depilation should not be performed on treated skin due to the potential for skin erosions. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. This product is for external use only. Lactation: Use Adapalene Gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene Gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child [see Use in Specific Populations, Lactation (8.2) ] .
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION Adapalene (a dap` a leen) Gel, 0.3% This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2024 Important: Adapalene Gel, 0.3% is for use on the skin only (topical). Do not use Adapalene Gel, 0.3% in or on your mouth, eyes, or vagina. What is Adapalene Gel, 0.3%? Adapalene Gel, 0.3% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. It is not known if Adapalene Gel, 0.3% is safe and effective in children under 12 years of age or in people 65 years of age and older. Do not use Adapalene Gel, 0.3% if you are allergic to adapalene or any of the ingredients in Adapalene Gel, 0.3%. See the end of this Patient Information leaflet for a complete list of ingredients in Adapalene Gel, 0.3%. Before using Adapalene Gel, 0.3% tell your healthcare provider about all your medical conditions, including if you: have other skin problems, including cuts, abrasions, sunburn, or skin that is dry, itchy, or red. are pregnant or plan to become pregnant. It is not known if Adapalene Gel, 0.3%, can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if adapalene passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use Adapalene Gel, 0.3%. If you use Adapalene Gel, 0.3% while breastfeeding, use Adapalene Gel, 0.3% on the smallest area of the skin and for the shortest time needed. Do not apply Adapalene Gel, 0.3% to areas that may increase the risk of getting Adapalene Gel, 0.3% in your child's mouth or eyes. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Adapalene Gel, 0.3%? Use Adapalene Gel, 0.3% exactly as your healthcare provider tells you to use it. Apply Adapalene Gel, 0.3% 1 time a day in the evening. Tell your healthcare provider if you do not notice a difference in your acne after using Adapalene Gel, 0.3% for 12 weeks. Applying Adapalene Gel, 0.3%: Wash the area where Adapalene Gel, 0.3% will be applied with a mild soap that does not contain a medicine and pat dry. Adapalene Gel, 0.3% comes in a tube and a pump. If you have been prescribed the: Tube: Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas. Pump: Depress the pump to dispense a small amount of Adapalene Gel, 0.3% and spread a thin layer over the entire face and any other affected area. Do not apply Adapalene Gel, 0.3% on areas of the skin around your eyes, lips, nose, and mouth. Wash your hands after applying Adapalene Gel, 0.3%. What should I avoid while using Adapalene Gel, 0.3%? Avoid spending time in sunlight, including sunlamps. Adapalene Gel, 0.3% can make your skin sensitive to the sun and the light from sunlamps. Use sunscreen and wear hat and clothes that cover the areas treated with Adapalene Gel, 0.3% if you have to be in sunlight. Cold weather and wind may irritate your skin treated with Adapalene Gel, 0.3%. Do not apply Adapalene Gel, 0.3% to cuts, abrasions, sunburned skin, or skin that is dry, itchy, or red. Avoid skin products that may dry or irritate your skin such as harsh soaps or cleansers, soaps and cosmetics that make your skin dry, and products that contain high levels of alcohol, astringents, spices, or limes. Avoid the use of "waxing" as a hair removal method on skin treated with 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: Allergic reactions. Adapalene Gel, 0.3% may cause serious allergic reactions that sometimes may require medical treatment. Stop using Adapalene Gel, 0.3% and tell your healthcare provider or get medical help right away if you have any of these symptoms of an allergic reaction: skin rash, itching or hives trouble breathing or chest pain swelling of your face, eyes, lips, tongue or throat Skin reactions at the treated site. Adapalene Gel, 0.3% may cause skin reactions including redness, scaling, dryness, stinging, and burning. These skin reactions are most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of Adapalene Gel, 0.3%. Your healthcare provider may tell you to use a moisturizer, decrease how often you use Adapalene Gel, 0.3%, or stop treatment with Adapalene Gel, 0.3%, if you get any skin reactions. If you use a moisturizer, you should avoid moisturizers that contain alpha hydroxy or glycolic acid. Ask your healthcare provider or pharmacist if you are not sure. The most common side effects of Adapalene Gel, 0.3% include dry skin, skin pain, itching, and skin peeling. These are not all the possible side effects of Adapalene Gel, 0.3% . 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 Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914. How should I store Adapalene Gel, 0.3%? Store Adapalene Gel, 0.3% at room temperature between 68° F to 77° F (20° C to 25° C). Do not freeze Adapalene Gel, 0.3% Keep Adapalene Gel, 0.3% and all medicines out of the reach of children. General information about the safe and effective use of 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. You can also ask your pharmacist or healthcare provider 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 homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: June 2024 |
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Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES 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 trial, conducted in a total of 653 subjects 12 to 52 years of age with acne vulgaris of mild to moderate severity. All female subjects of child-bearing potential enrolled in the trial were required to have a negative urine pregnancy test at the beginning of the trial and were required to practice a highly effective method of contraception during the trial. Female subjects who were pregnant, nursing or planning to become pregnant were excluded from the trial. Subjects enrolled in the trial were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%). An equal number of males (49.5%) and females (50.5%) enrolled. Success was defined as "Clear" or "Almost Clear" in the Investigator's Global Assessment (IGA). 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, 0.3% Adapalene Gel, 0.1% Vehicle Gel N=258 N=261 N=134 IGA Success Rate 53 (21%) 41 (16%) 12 (9%) Inflammatory Lesions Mean Baseline Count 27.7 28.1 27.2 Mean Absolute (%) Reduction 14.4 (51.6%) 13.9 (49.7%) 11.2 (40.7%) Non-inflammatory Lesions Mean Baseline Count 39.4 41 40 Mean Absolute (%) Reduction 16.3 (39.7%) 15.2 (35.2%) 10.3 (27.2%) Total Lesions Mean Baseline Count 67.1 69.1 67.2 Mean Absolute (%) Reduction 30.6 (45.3%) 29 (41.8%) 21.4 (33.7%)
| Adapalene Gel, 0.3% | Adapalene Gel, 0.1% | Vehicle Gel | |
|---|---|---|---|
| N=258 | N=261 | N=134 | |
| IGA Success Rate | 53 (21%) | 41 (16%) | 12 (9%) |
| Inflammatory Lesions | |||
| Mean Baseline Count | 27.7 | 28.1 | 27.2 |
| Mean Absolute (%) Reduction | 14.4 (51.6%) | 13.9 (49.7%) | 11.2 (40.7%) |
| Non-inflammatory Lesions | |||
| Mean Baseline Count | 39.4 | 41 | 40 |
| Mean Absolute (%) Reduction | 16.3 (39.7%) | 15.2 (35.2%) | 10.3 (27.2%) |
| Total Lesions | |||
| Mean Baseline Count | 67.1 | 69.1 | 67.2 |
| Mean Absolute (%) Reduction | 30.6 (45.3%) | 29 (41.8%) | 21.4 (33.7%) |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of Adapalene Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). 8.2 Lactation Risk Summary There are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Adapalene Gel, 0.3% and any potential adverse effects on the breastfed child from Adapalene Gel, 0.3%, or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use Adapalene Gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene Gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. 8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12. 8.5 Geriatric Use Clinical studies of Adapalene Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene Gel, 0.3% is supplied in the following sizes. 45 g tube – NDC 51672-1377-6 45 g pump – NDC 51672-1377-9 S torage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.
Storage and handling
Information about safe storage and handling of the drug product.S torage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API