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Epiduo

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Epiduo uses


1 INDICATIONS AND USAGE

Epiduo gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Epiduo gel 0.1% / 2.5% is a combination of Epiduo, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)

2 DOSAGE AND ADMINISTRATION

For topical use only; Epiduo gel is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Epiduo gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes.

Epiduo gel is not for oral, ophthalmic, or intravaginal use. (2) Apply a thin film of Epiduo gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. (2)

3 DOSAGE FORMS AND STRENGTHS

Each gram of Epiduo gel contains 1 mg (0.1%) Epiduo, USP and 25 mg (2.5%) benzoyl peroxide, USP in a white to very pale yellow, opaque, aqueous based gel.

Each gram of Epiduo gel contains 1 mg (0.1%) Epiduo, USP and 25 mg (2.5%) benzoyl peroxide, USP. (3)

4 CONTRAINDICATIONS

None

None. (4)

5 WARNINGS AND PRECAUTIONS

Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo gel and may necessitate discontinuation. (5.2)

5.1 Ultraviolet Light and Environmental Exposure

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.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Epiduo gel.

5.2 Local Cutaneous Reactions

Erythema, scaling, dryness, and stinging/burning may be experienced with use of 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).

6 ADVERSE REACTIONS

Most commonly reported adverse events in patients treated with Epiduo gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

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, 1401 subjects were exposed to Epiduo gel. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with Epiduo gel and those reported in subjects treated with the vehicle gel are presented in Table 1:


System Organ Class/Preferred Term


Epiduo and Benzoyl


Peroxide gel


Vehicle gel


N = 564


N = 489


Subjects with AE (s)


14%

4%

Dry Skin


7%

2%

Contact dermatitis


3%

<1%

Application site burning


2%

<1%

Application site irritation


1%

<1%

Skin irritation


1%

0%

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.




Treatment Emergent Signs and Symptoms


Maximum Severity During Treatment


End of Treatment Severity (12 Weeks)


Mild


Moderate


Severe


Mild


Moderate


Severe


Erythema


27%

13%

1%

8%

2%

1%

Scaling


35%

11%

1%

9%

1%

<1%

Dryness


41%

13%

1%

10%

2%

<1%

Stinging/burning


41%

15%

3%

7%

2%

1%

Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.


During a pediatric clinical trial, 285 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 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.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Epiduo gel: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. 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.

7 DRUG INTERACTIONS

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with Epiduo gel.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

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 0.15 to 5 mg adapalene/kg/day, up to 25 times the maximum recommended human dose (MRHD) of 2 grams of Epiduo gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. 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 0.6 to 6 mg adapalene/kg/day [25 to 59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

8.3 Nursing Mothers

It is not known whether Epiduo 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.

8.4 Pediatric Use

Safety and effectiveness of Epiduo gel in pediatric patients under the age of 9 have not been established.

8.5 Geriatric Use

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.

11 DESCRIPTION

Epiduo gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene USP, 0.1% and benzoyl peroxide USP, 2.5%.

Epiduo USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for Epiduo, USP is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula:

Epiduo, USP:

Molecular formula: C28H28O3 Molecular weight: 412.5

Benzoyl Peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes.

The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula:

Benzoyl Peroxide, USP:

Molecular formula: C14H10O4 Molecular weight: 242.23

Inactive ingredients: carbomer 980, docusate sodium, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sorbitan monooleate and xanthan gum.

23e027be-figure-01 23e027be-figure-02

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epiduo

Epiduo binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Epiduo is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of Epiduo for the treatment of acne is unknown.

Benzoyl peroxide

Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

12.2 Pharmacodynamics

Pharmacodynamics of Epiduo gel is unknown.

12.3 Pharmacokinetics

A pharmacokinetic study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of Epiduo gel applied to 1000 cm2 of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable Epiduo plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest Epiduo Cmax and AUC0-24h was 0.21 ng/mL and 1.99 ng-h/mL, respectively. Excretion of Epiduo 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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with Epiduo gel. Carcinogenicity studies with Epiduo have been conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m2/day), and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9 mg/m2/day). In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of Epiduo gel. In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed.

No significant increase in tumor formation was observed in rodents topically treated with 15 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in Epiduo gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg. In terms of body surface area, these levels are 27 to 40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years.

The role of benzoyl peroxide as a tumor promoter has been well established in several animal species. However, the significance of this finding in humans is unknown.

In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks.

No photocarcinogenicity studies were conducted with Epiduo. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources.

Epiduo 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.

In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring.

No fertility studies were conducted with benzoyl peroxide.

14 CLINICAL STUDIES

The safety and efficacy of Epiduo gel applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing Epiduo gel to the gel vehicle in acne subjects. Treatment response was defined as the percent of subjects who had a two grade improvement and rated ‘Clear’ and ‘Almost Clear’ at Week 12 based on the Investigator’s Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of ‘Clear’ corresponded to residual hyperpigmentation and erythema may be present. An IGA score of ‘Almost Clear’ corresponded to a few scattered comedones and a few small papules.

In Study 1, 517 subjects were randomized to Epiduo gel, Epiduo 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of these 517 subjects was 15 years old and 60% were males.

At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects had a baseline IGA score of ‘Moderate’ which corresponded to more than half of the face is involved, many comedones, papules and pustules. The efficacy results at week 12 are presented in Table 3.

In Study 2, 1668 subjects were randomized to Epiduo gel, Epiduo 0.1% in vehicle gel, benzoyl peroxide 2.5% in vehicle gel, or vehicle gel. The median age of subjects was 16 years old and 49% were males. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions as well as an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.

In study 3, 285 pediatric subjects 9 to 11 years of age were randomized to Epiduo gel or vehicle gel. The median age of subjects was 11 years and 24% were males. At baseline, subjects had a minimum of 20 but not more than 100 total lesions (inflammatory and/or non-inflammatory) with an Investigator Global Assessment score of ‘Moderate’. The efficacy results at week 12 are presented in Table 3.


Study 1


Epiduo and


Epiduo 0.1% in

Benzoyl Peroxide 2.5% in

Vehicle gel

Benzoyl Peroxide gel

Vehicle gel

Vehicle gel

(N = 149)

(N = 148)

(N = 149)

(N = 71)

IGA: Two Grade


Improvement and Clear

32

18

18

4

or Almost Clear


(21.5%)

(12.2%)

(12.1%)

(5.6%)

Inflammatory Lesions:


Mean Absolute


16.0

11.4

10.5

9.5

(Percent) Change


(52.4%)

(39.9%)

(35.8%)

(31.8%)

Non-inflammatory


Lesions: Mean Absolute

23.4

15.2

13.7

13.2

(Percent) Change


(45.9%)

(29.6%)

(32.2%)

(27.8%)

Study 2


Epiduo and

Epiduo 0.1% in

Benzoyl Peroxide 2.5%

Vehicle gel

Benzoyl Peroxide gel

Vehicle gel

in Vehicle gel

(N = 415)

(N = 420)

(N = 415)

(N = 418)

IGA: Two Grade


Improvement and Clear

125

83

92

47

or Almost Clear


(30.1%)

(19.8%)

(22.2%)

(11.3%)

Inflammatory Lesions:


Mean Absolute


15.4

12.3

13.7

8.7

(Percent) Change


(53.4%)

(41.7%)

(47.6%)

(30.2%)

Non-inflammatory


Lesions: Mean


Absolute (Percent)


24.6

21.0

19.2

11.3

Change


(48.1%)

(40.8%)

(37.2%)

(23.2%)

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.


Study 3


Epiduo Gel

Vehicle Gel

N=142

N=143

IGA: Two Grade Improvement and Clear or Almost Clear

67 (47.2%)

22 (15.4%)

Inflammatory Lesions: Mean Absolute (Percent) Change

7.4 (36.0%)

0.7 (-13.2%)*

Non-inflammatory Lesions: Mean Absolute (Percent) Change

20.2 (54.7%)

2.9 (2.3%)

** - That is, a mean percent increase of 13.2%

16 HOW SUPPLIED/STORAGE AND HANDLING

Epiduo gel 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:

45 gram tube NDC 0472-0310-45

45 gram pump NDC 0472-0310-38

STORAGE AND HANDLING

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and keep away from heat. Keep tube tightly closed.

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Information for Patients


Made in Canada

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised – October 2016

2007424

PATIENT INFORMATION

Epiduo (a dap ' a leen) and Benzoyl Peroxide (ben' zoe il per ox' ide)


Gel 0.1%/2.5%

Rx Only

Important: 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.

Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if Epiduo gel is safe and effective in children younger than 9 years old.

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 non-prescription 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.

How should I use Epiduo gel?


Applying Epiduo gel:


What should I avoid while using Epiduo gel?


What are the possible side effects of Epiduo gel?

Epiduo gel may cause serious side effects including:


Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using Epiduo gel.

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 Epiduo gel. 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 Actavis at 1-800-432-8534.

How should I store Epiduo gel?


Keep Epiduo gel and all medicines out of the reach of children.

General information about Epiduo gel

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. You can also ask your doctor or pharmacist for information about Epiduo gel that is written for health professionals.

What are the ingredients in Epiduo gel?

Active ingredient: Epiduo, USP and benzoyl peroxide, USP

Inactive ingredients: carbomer 980, docusate sodium, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sorbitan monooleate and xanthan gum.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Made in Canada

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised – October 2016

2007424

Epiduo pharmaceutical active ingredients containing related brand and generic drugs:


Epiduo available forms, composition, doses:


Epiduo destination | category:


Epiduo Anatomical Therapeutic Chemical codes:


Epiduo pharmaceutical companies:


References

  1. Dailymed."3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."BENZOYL PEROXIDE; ERYTHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Epiduo?

Depending on the reaction of the Epiduo after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Epiduo not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Epiduo addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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