How To Apply Epiduo
Medically reviewed by Drugs. Last updated on Feb 1, Epiduo gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Use a pea-sized amount for each area of the face e. Avoid the eyes, lips and mucous membranes.
Each gram of Epiduo gel contains 1 mg 0. Exposure to sunlight, including sunlamps, should be minimized during the use of Epiduo gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel, e. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Epiduo gel.
These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of Epiduo gel, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin.
As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with Epiduo gel. Avoid concomitant use of other potentially irritating topical products medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical trials, subjects were exposed to Epiduo gel. A total of subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.
Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging. During a pediatric clinical trial, children with acne vulgaris, 9 to 11 years of age were treated with Epiduo gel or with the vehicle gel once daily for 12 weeks.
Overall, the safety profile of Epiduo gel in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed adverse events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.
The following adverse reactions have been identified during postapproval use of Epiduo gel: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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.
There are no well-controlled trials in pregnant women treated with Epiduo gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, Epiduo gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.
Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.
Dermal teratology studies conducted in rats and rabbits at doses of 0. It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of Epiduo gel.
Because many drugs are excreted in human milk, caution should be exercised when Epiduo gel is administered to a nursing woman. Safety and effectiveness of Epiduo gel in pediatric patients under the age of 9 have not been established. Clinical studies of Epiduo gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Epiduo adapalene and benzoyl peroxide gel, 0. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties.
The chemical name for adapalene is 6-[3- 1-adamantyl methoxyphenyl] naphthoic acid. It has the following structural formula:. C 28 H 28 O 3 Molecular weight: 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. C 14 H 10 O 4 Molecular weight: Epiduo gel contains the following inactive ingredients: 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. The highest adapalene C max and AUC h was 0. Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of Epiduo gel in pediatric subjects have not been evaluated.
Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine. No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with Epiduo gel. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0. In terms of body surface area, the highest dose levels are 9. In the rat study, an increased incidence of benign and malignant pheochromocytomas in the adrenal medulla of male rats was observed.
In terms of body surface area, these levels are times the MRHD. 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 photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs e. 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 in vitro Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay or in vivo 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. The safety and efficacy of Epiduo gel applied once daily for the treatment of acne vulgaris were assessed in two week, multicenter, controlled clinical studies of similar design, comparing Epiduo gel to the gel vehicle in acne subjects.
In Study 1, subjects were randomized to Epiduo gel, adapalene 0. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to non-inflammatory lesions.
In Study 2, subjects were randomized to Epiduo gel, adapalene 0. The efficacy results at week 12 are presented in Table 3. In Study 3, pediatric subjects 9 to 11 years of age were randomized to Epiduo gel or vehicle gel. 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.
Epiduo adapalene and benzoyl peroxide gel 0. Apply Epiduo gel as a thin layer, avoiding the eyes, lips and mucous membranes.
For use on the skin only topical. Do not use Epiduo gel in or on your mouth, eyes, or vagina. Read this Patient Information leaflet about Epiduo gel before you start using it and each time you get a refill.
There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Epiduo gel, talk with your doctor or pharmacist. What is Epiduo gel? Epiduo gel is a prescription medicine for skin use only topical used to treat acne vulgaris in people 9 years of age and older.
What should I tell my doctor before using Epiduo gel? Before you use Epiduo gel, tell your doctor if you:. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
Especially tell your doctor if you use any other medicine for acne. Using Epiduo gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using Epiduo gel.
These are not all the possible side effects of Epiduo gel. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet.
Do not use Epiduo gel for a condition for which it was not prescribed. Do not give Epiduo gel to other people, even if they have the same symptoms you have.
It may harm them. This Patient Information leaflet summarizes the most important information about Epiduo gel. If you would like more information, talk with your doctor.
How to apply epiduo
Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: Avoid using skin products that can cause dryness or irritation, such as harsh soaps, shampoos, or skin cleansers, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.
It is not known whether Epiduo will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. It is not known whether adapalene and benzoyl peroxide topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Use Epiduo gel exactly as your doctor has prescribed it for you. Follow all directions on your prescription label.
Do not use this medicine in larger or smaller amounts or for longer than recommended. Using more of this medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Benzoyl peroxide topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using Epiduo gel, you may choose to apply a "test dose" to see if you have a reaction.
Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day. Clean and pat dry the skin to be treated.
Use a pea-sized amount of the gel for each treatment area chin, forehead, and each cheek. Apply the medicine in a thin layer and rub in gently.
Call your doctor if your symptoms do not improve, or if they get worse while using this medicine. A pea-size amount is applied to each area of the face e.
Avoid the eyes, lips, and mucous membranes. Epiduo dosage information in more detail. Apply the missed dose as soon as you remember. Inform your doctor before starting any new medications. In the case that you miss a dose of Epiduo: Apply the missed dose as soon as you remember.
Skip your missed dose if it is almost time to apply your next scheduled dose of Epiduo. Do not apply extra doses of Epiduo to make up for the missed dose. These side effects are common in the first week of therapy but typically subside thereafter.
Common side effects of Epiduo: Dryness and scaling of skin Feeling of warmth Burning. Less common side effects of Epiduo: Blistering, burning, or peeling skin Itchiness, redness, or swelling of the skin Pain of the skin.
Get emergency medical help if you have any of these signs of an allergic reaction to Epiduo: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof.
This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may also report side effects at http: Epiduo side effects in more detail.
If you think there has been an overdose, call your poison control center or get medical care right away.
How to apply epiduo
Less common side effects of Epiduo: Do not use on open wounds or on sunburned, windburned, dry, how to apply epiduo, chapped, or irritated skin. Benzoyl peroxide topical can cause a rare but serious allergic reaction or severe skin irritation. Apply sunscreen every day and minimize your exposure to the sun. It is not known whether adapalene and benzoyl peroxide topical passes into breast milk or if it could harm a nursing baby.
I've used Epiduo and my derm recommended a pea-size amount to use on the area you want to apply it to, after washing your face with a mild cleanser. I've found that over-application causes my skin to dry out and sometimes peel, but this can be helped with moisturizer, which was also recommended. 3/15/ · Apply your Epiduo first, let it absorb for about 20 minutes, and layer the moisturizer over the top. (You can also ask your dermatologist how he would like you to incorporate a moisturizer into your treatment regimen.) If you have any questions about your acne treatment, don't be erectiledysfunctioncure.icu: Angela Palmer. The efficacy of Epiduo is best evaluated after weeks of use. If this amount of time has elapsed and you believe you have worsened, I would certainly discontinue use. At times, the initial use of epiduo can cause a temporary exacerbation of acne, especially as it keeps your pores patent and debris can rise .
How to apply epiduo:
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How to apply epiduo
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