Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 0299-5890 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Epsolay |
||||||
| Type | Brand | ||||||
| Active Ingredients |
|
||||||
| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 308693, 2600969 |
||||||
| Application Number | NDA214510 | ||||||
| Labeler Name | Galderma Laboratories, L.P. | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
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 Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 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 reaction 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 two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years. Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle * Application site edema includes: application site swelling and application site edema EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema* 4 (1%) 0 (0%) During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning. Table 2 presents the local tolerability assessments by severity grade at Week 12. Table 2: Facial Cutaneous Tolerability Assessment * Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12. Sign/Symptom EPSOLAY N=455* Severity at Week 12 Mild Moderate Severe Dryness 25% 7% 0% Itching 24% 6% 0% Scaling 13% 4% 0% Stinging/Burning 20% 3% 1% In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.
| * Application site edema includes: application site swelling and application site edema | ||
| EPSOLAY N=488 | Vehicle N=234 | |
| Application site pain | 11 (2%) | 2 (1%) |
| Application site erythema | 11 (2%) | 2 (1%) |
| Application site pruritus | 6 (1%) | 1 (<1%) |
| Application site edema* | 4 (1%) | 0 (0%) |
| * Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12. | |||
| Dryness | 25% | 7% | 0% |
| Itching | 24% | 6% | 0% |
| Scaling | 13% | 4% | 0% |
| Stinging/Burning | 20% | 3% | 1% |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action in the treatment of rosacea is unknown. 12.2 Pharmacodynamics The pharmacodynamics of EPSOLAY in the treatment of rosacea are unknown. 12.3 Pharmacokinetics Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid, an endogenous substance, which is eliminated in the urine. The systemic exposure of benzoyl peroxide following the application of EPSOLAY was not assessed.
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 Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action in the treatment of rosacea 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 The pharmacodynamics of EPSOLAY in the treatment of rosacea are unknown.
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 Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid, an endogenous substance, which is eliminated in the urine. The systemic exposure of benzoyl peroxide following the application of EPSOLAY was not assessed.
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 EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY [ see Warnings and Precautions ( 5.1 ) ]. A history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY. ( 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 EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide. The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients. 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 Before initial use, prime the pump until the first drop of cream is released. Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin. Avoid the eyes, lips and mouth. Wash hands after application. EPSOLAY may bleach hair or colored fabric. EPSOLAY is for topical use only. Not for oral, ophthalmic, or intravaginal use. Discard unused EPSOLAY 60 days after first use. Apply to the affected areas once daily. ( 2 ) Wash hands after application. ( 2 ) Not for oral, ophthalmic, 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 Cream, 5%. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide in a white to off-white base. Cream, 5%. ( 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 EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.EPSOLAY Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Anhydrous Citric Acid Cetrimonium Chloride Cetyl Alcohol Cyclomethicone Edetate Disodium Glycerin Glyceryl Mono And Dipalmitostearate Hydrochloric Acid Lactic Acid, Unspecified Form Peg-100 Stearate Phenoxyethanol Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) Silicon Dioxide Sodium Hydroxide Water figure-3 figure-4 figure-1 figure-2 30g-carton-image
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 Carcinogenicity, mutagenicity, and impairment of fertility studies were not conducted with EPSOLAY. 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. No significant increase in tumor formation was observed in rats treated topically with a 15 to 25% benzoyl peroxide carbopol gel (3 to 5 times the concentration of benzoyl peroxide in EPSOLAY) for two years. Similar results were obtained in mice topically treated with 25% benzoyl peroxide gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide gel for rest of the 2 years study period and in mice topically treated with 5% benzoyl peroxide gel for two years. Bacterial mutagenicity assays (Ames test) conducted with benzoyl peroxide have provided mixed results; mutagenic potential was observed in a few studies but not in a majority of investigations. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies were not conducted with benzoyl peroxide.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and impairment of fertility studies were not conducted with EPSOLAY. 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. No significant increase in tumor formation was observed in rats treated topically with a 15 to 25% benzoyl peroxide carbopol gel (3 to 5 times the concentration of benzoyl peroxide in EPSOLAY) for two years. Similar results were obtained in mice topically treated with 25% benzoyl peroxide gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide gel for rest of the 2 years study period and in mice topically treated with 5% benzoyl peroxide gel for two years. Bacterial mutagenicity assays (Ames test) conducted with benzoyl peroxide have provided mixed results; mutagenic potential was observed in a few studies but not in a majority of investigations. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies were not conducted with benzoyl peroxide.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction 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 two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years. Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle * Application site edema includes: application site swelling and application site edema EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema* 4 (1%) 0 (0%) During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning. Table 2 presents the local tolerability assessments by severity grade at Week 12. Table 2: Facial Cutaneous Tolerability Assessment * Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12. Sign/Symptom EPSOLAY N=455* Severity at Week 12 Mild Moderate Severe Dryness 25% 7% 0% Itching 24% 6% 0% Scaling 13% 4% 0% Stinging/Burning 20% 3% 1% In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.
| * Application site edema includes: application site swelling and application site edema | ||
| EPSOLAY N=488 | Vehicle N=234 | |
| Application site pain | 11 (2%) | 2 (1%) |
| Application site erythema | 11 (2%) | 2 (1%) |
| Application site pruritus | 6 (1%) | 1 (<1%) |
| Application site edema* | 4 (1%) | 0 (0%) |
| * Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12. | |||
| Dryness | 25% | 7% | 0% |
| Itching | 24% | 6% | 0% |
| Scaling | 13% | 4% | 0% |
| Stinging/Burning | 20% | 3% | 1% |
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 - 30 g Pump Carton Rx Only NDC 0299-5890-30 EPSOLAY ® (benzoyl peroxide) cream, 5% For topical use only. Not for ophthalmic, oral, or intravaginal use. Package is not child-resistant. Keep out of reach of children. 30g Pump P57494-0
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.EPSOLAY® (ep' soe lay) (benzoyl peroxide) cream Important: EPSOLAY is for use on the skin only (topical). Do not use EPSOLAY in or on your mouth, eyes or vagina. What is EPSOLAY? EPSOLAY is a prescription medicine used on the skin (topical) to treat adults with pimples and bumps caused by a condition called rosacea. It is not known if EPSOLAY is safe and effective in children. Do not use EPSOLAY if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in EPSOLAY. See the end of this leaflet for a complete list of ingredients in EPSOLAY. Before using EPSOLAY, tell your healthcare provider about all of your medical conditions, including if you: have other skin problems, including eczema, cuts, or sunburn. are pregnant or plan to become pregnant. It is not known if EPSOLAY will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if EPSOLAY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with EPSOLAY. 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 EPSOLAY? Use EPSOLAY exactly as your healthcare provider tells you. Apply EPSOLAY to your face 1 time each day on clean and dry skin. Before you use EPSOLAY for the first time, prime the pump by pressing down until the first drop of cream is released. Use the pump to dispense a pea-size amount of EPSOLAY onto your fingertip. Spread a thin layer over each area of your face (forehead, chin, nose, each cheek). Avoid contact with your eyes, lips and mouth. Wash your hands right away after applying EPSOLAY. What should I avoid while using EPSOLAY? Avoid using EPSOLAY on skin areas with cuts, abrasions, eczema, or on sunburned skin. Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. EPSOLAY may make your skin more sensitive to the sun and the light from sunlamps and tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using EPSOLAY if you get sunburn. Avoid getting EPSOLAY in your hair or on colored fabric. EPSOLAY may bleach hair or colored fabric. What are the possible side effects of EPSOLAY? EPSOLAY may cause serious side effects, including: Allergic reactions. Stop using EPSOLAY and get medical help right away if you have any of the following symptoms during treatment with EPSOLAY: hives, rash or severe itching swelling of your face, eyes, lips, tongue, or throat trouble breathing or throat tightness feeling faint, dizzy, or lightheaded Skin irritation. EPSOLAY may cause skin irritation such as redness, scaling, dryness, stinging, or burning. You may use a moisturizer if you develop skin irritation. Tell your healthcare provider if your symptoms do not improve, you may need to stop treatment with EPSOLAY. Sensitivity to sunlight . See “What should I avoid while using EPSOLAY?” The most common side effects of EPSOLAY include pain, redness, itching, and swelling at application site. These are not all the possible side effects with EPSOLAY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store EPSOLAY ? Store EPSOLAY at room temperature between 68°F to 77°F (20°C to 25°C). Keep EPSOLAY away from heat. Do not freeze EPSOLAY. Throw away (discard) unused EPSOLAY 60 days after first use. Keep EPSOLAY and all medicines out of the reach of children. General information about the safe and effective use of EPSOLAY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPSOLAY for a condition for which it was not prescribed. Do not give EPSOLAY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EPSOLAY that is written for health professionals. What are the ingredients in EPSOLAY? Active ingredient: benzoyl peroxide Inactive ingredients : anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide. Marketed by GALDERMA LABORATORIES, L.P., Dallas, TX 75201 USA Made in Canada All trademarks are the property of their respective owners. P57267-1 For more information, go to www.EPSOLAY.com or call GALDERMA LABORATORIES, L.P. at 1-866-735-4137. This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 4/2023
EPSOLAY: 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). Hypersensitivity Inform patients that serious hypersensitivity reactions occurred with the use of benzoyl peroxide products. If a patient experiences a serious hypersensitivity reaction, instruct patient to discontinue EPSOLAY immediately and seek medical help [ see Warnings and Precautions ( 5.1 )] . Skin Irritation/Contact Dermatitis Inform patients that EPSOLAY may cause irritation such as erythema, scaling, dryness, stinging or burning. Advise the patient to use a moisturizer for irritation [see Warnings and Precautions ( 5.2 )] . Photosensitivity Advise patients to minimize or avoid exposure to natural or artificial light (tanning beds or UVA/B treatment) and to use sun protective measures, if patients need to be outdoors while using EPSOLAY [see Warnings and Precautions ( 5.3 )] . Administration Instructions Advise patients to apply EPSOLAY exactly as directed in a thin layer, avoiding the eyes, lips and mouth and to wash hands immediately after application. Inform patients that EPSOLAY may bleach hair or colored fabric [see Dosage and Administration ( 2 )] . Marketed by: GALDERMA LABORATORIES, L.P. Dallas, TX 75201 USA Made in Canada All trademarks are the property of their respective owners. P57267-1
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION
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 EPSOLAY was evaluated in two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 [NCT03448939] and Trial 2 [NCT03564119]) in subjects with moderate-to-severe papulopustular rosacea. The trials were conducted in 733 subjects, aged 18 years and older. Subjects were treated once daily for 12 weeks with either EPSOLAY or vehicle cream. Subjects were required to have a minimum of 15 to 70 total inflammatory lesions (papules and/or pustules) and no more than 2 nodules (where a nodule was defined as a papule or pustule greater than 5 mm in diameter) and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline. Overall, 93% of subjects were Caucasian, 73% were female, and the mean age was 51 years (ranged from 18 to 85 years). At baseline, subjects had a mean inflammatory lesion count of 27.5, 89% were scored as moderate (IGA=3), and 11% scored as severe (IGA=4). The co-primary efficacy endpoints in both trials were the proportion of subjects with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”) with at least a two-grade reduction from baseline, and the absolute change from baseline in inflammatory lesion counts at Week 12. The results at Week 12 are presented in Table 3 . EPSOLAY was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both trials, see Figure 1 through Figure 4. Table 3: Efficacy Results of EPSOLAY in Subjects with Moderate to Severe Papulopustular Rosacea at Week 12 * Investigator Global Assessment (IGA) success was defined as an IGA score of 0 (“clear”)or 1 (“almost clear”) with at least a two-grade reduction from baseline. † Means presented in table are Least Square (LS) Means. Trial 1 EPSOLAY Vehicle (N=243) (N=118) Trial 2 EPSOLAY Vehicle (N=250) (N=122) IGA Treatment Success* Difference from Vehicle (99% CI) 47.4% 20.7% 26.7% (16.7%, 36.8%) 49.2% 28.2% 21.0% (10.7%, 31.3%) Inflammatory Lesions Mean† Absolute Change Difference from Vehicle (95% CI) Mean† Percent Change Difference from Vehicle (95% CI) -17.4 -9.5 -7.9 (-10.0, -5.9) -68.2% -38.3% -29.9% (-37.8%, -22.0%) -20.3 -13.3 -6.9 (-9.0, -4.9) -69.4% -46.0% -23.4% (-30.5%, -16.3%) Figure 1: IGA Success Rate Over Time in Trial 1 Figure 2: IGA Success Rate Over Time in Trial 2 Figure 3: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time in Trial 1 Figure 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time in Trial 2
| * Investigator Global Assessment (IGA) success was defined as an IGA score of 0 (“clear”)or 1 (“almost clear”) with at least a two-grade reduction from baseline. † Means presented in table are Least Square (LS) Means. | ||
| Trial 1 EPSOLAY Vehicle (N=243) (N=118) | Trial 2 EPSOLAY Vehicle (N=250) (N=122) | |
| 47.4% 20.7% 26.7% (16.7%, 36.8%) | 49.2% 28.2% 21.0% (10.7%, 31.3%) | |
| -17.4 -9.5 -7.9 (-10.0, -5.9) -68.2% -38.3% -29.9% (-37.8%, -22.0%) | -20.3 -13.3 -6.9 (-9.0, -4.9) -69.4% -46.0% -23.4% (-30.5%, -16.3%) | |
| Figure 1: IGA Success Rate Over Time in Trial 1 | Figure 2: IGA Success Rate Over Time in Trial 2 |
| Figure 3: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time in Trial 1 | Figure 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time in Trial 2 |
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 Of the 733 subjects in the clinical trials of EPSOLAY, 127 (17%) subjects were 65 and over, while 37 (3%) subjects were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
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 of EPSOLAY for the treatment of inflammatory lesions of rosacea have not been established in pediatric patients.
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 The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure to the drug. Animal reproductive studies have not been conducted with EPSOLAY or benzoyl peroxide. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 is 2 to 4% and 15 to 20%, respectively.
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 The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure to the drug. Animal reproductive studies have not been conducted with EPSOLAY or benzoyl peroxide. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production. The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be metabolized by tissue and stomach esterases. Therefore, breastfeeding is not expected to result in exposure of the infant to EPSOLAY. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EPSOLAY and any potential adverse effects on the breastfed child from EPSOLAY or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of EPSOLAY for the treatment of inflammatory lesions of rosacea have not been established in pediatric patients. 8.5 Geriatric Use Of the 733 subjects in the clinical trials of EPSOLAY, 127 (17%) subjects were 65 and over, while 37 (3%) subjects were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
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 How Supplied EPSOLAY is a white to off-white cream supplied in an airless pump as follows: 30 gram pump: NDC 0299-5890-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Keep away from heat. Do not freeze. Discard unused cream 60 days after first use.
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling Store at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Keep away from heat. Do not freeze. Discard unused cream 60 days after first use.
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