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Drug overview for EPIDUO FORTE (adapalene/benzoyl peroxide):
Generic name: ADAPALENE/BENZOYL PEROXIDE (a-DAP-a-leen/BEN-zoe-il per-OX-ide)
Drug class: Acne Products
Therapeutic class: Dermatological
Adapalene is a synthetic, naphthoic acid-derivative retinoid.
No enhanced Uses information available for this drug.
Generic name: ADAPALENE/BENZOYL PEROXIDE (a-DAP-a-leen/BEN-zoe-il per-OX-ide)
Drug class: Acne Products
Therapeutic class: Dermatological
Adapalene is a synthetic, naphthoic acid-derivative retinoid.
No enhanced Uses information available for this drug.
DRUG IMAGES
EPIDUO FORTE 0.3-2.5% GEL PUMP
The following indications for EPIDUO FORTE (adapalene/benzoyl peroxide) have been approved by the FDA:
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
The following dosing information is available for EPIDUO FORTE (adapalene/benzoyl peroxide):
The manufacturer states that safety and efficacy of adapalene in children younger than 12 years of age have not been established.
For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime.
During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.
For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime.
During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.
Adapalene is applied topically to the skin as a 0.1% cream or 0.1% gel.
Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.
Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort. Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided.
If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs.
In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy.
Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin. Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution.
In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution.
Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene.
Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.
Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort. Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided.
If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists. Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs.
In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy.
Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin. Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution.
In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution.
Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| EPIDUO FORTE 0.3-2.5% GEL PUMP | Maintenance | Adults apply a thin layer to the affected area(s) of the face and/or upper trunk after washing by topical route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADAPALENE-BNZYL PEROX 0.3-2.5% | Maintenance | Adults apply a thin layer to the affected area(s) of the face and/or upper trunk after washing by topical route once daily |
The following drug interaction information is available for EPIDUO FORTE (adapalene/benzoyl peroxide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for EPIDUO FORTE (adapalene/benzoyl peroxide):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Exfoliative dermatitis |
| Skin photosensitivity |
There are 0 moderate contraindications.
The following adverse reaction information is available for EPIDUO FORTE (adapalene/benzoyl peroxide):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 16 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Skin irritation |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Dermatitis due to topical drug Dyspnea Eczema Eyelid edema Facial edema Hypersensitivity drug reaction Periorbital edema Pharyngeal edema Pruritus of skin Skin rash Syncope Throat constriction Urticaria |
There are 18 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dry skin Erythema Pruritus of skin Skin scaling Stinging of skin |
Abnormal desquamation Atopic dermatitis Dry skin Erythema Sensation of warmth Skin irritation Stinging of skin |
| Rare/Very Rare |
|---|
|
Conjunctivitis Contact dermatitis Dyschromia Lip swelling Skin inflammation Skin photosensitivity |
The following precautions are available for EPIDUO FORTE (adapalene/benzoyl peroxide):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for EPIDUO FORTE (adapalene/benzoyl peroxide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for EPIDUO FORTE (adapalene/benzoyl peroxide)'s list of indications:
| Acne vulgaris | |
| L70.0 | Acne vulgaris |
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