Erythromycin/Benzoyl Peroxide: Difference between revisions
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* Dosing information | * Dosing information | ||
:* | :* Erythromycin/Benzoyl Peroxide Topical Gel should be applied '''twice daily''', morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in adult patients. | ||
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|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Erythromycin/Benzoyl Peroxide in pediatric patients. | ||
|contraindications= | |contraindications=Erythromycin/Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components. | ||
|warnings=Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. | |warnings=[[Pseudomembranous colitis]] has been reported with nearly all antibacterial agents, including [[erythromycin]], and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. | ||
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." | Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of [[clostridia]]. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." | ||
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. | After the diagnosis of [[pseudomembranous colitis]] has been established, therapeutic measures should be initiated. Mild cases of [[pseudomembranous colitis]] usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficult [[colitis]]. | ||
|clinicalTrials=In controlled clinical trials, the incidence of adverse reactions associated with the use of | |clinicalTrials=In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin/Benzoyl Peroxide Topical Gel was approximately 3%. These were dryness and urticarial reaction. | ||
The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. | The following additional local adverse reactions have been reported occasionally: irritation of the skin including [[peeling]], [[itching]], [[burning sensation]], [[erythema]], inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, [[oiliness]] and tenderness of the skin have also been reported. | ||
|postmarketing=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding postmarketing experience. | |postmarketing=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding postmarketing experience. | ||
|drugInteractions=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Drug Interaction. | |drugInteractions=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Drug Interaction. | ||
|FDAPregCat=C | |FDAPregCat=C | ||
|useInPregnancyFDA=Animal reproduction studies have not been conducted with | |useInPregnancyFDA=Animal reproduction studies have not been conducted with Erythromycin/Benzoyl Peroxide Topical Gel or benzoyl peroxide. | ||
There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. | There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed [[erythromycin]] base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. | ||
There are no well-controlled trials in pregnant women with | There are no well-controlled trials in pregnant women with Erythromycin/Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin/Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin/Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed. | ||
|useInNursing=It is not known whether | |useInNursing=It is not known whether Erythromycin/Benzoyl Peroxide Topical Gel is excreted in human milk after topical application. However, [[erythromycin]] is excreted in human milk following oral and parenteral [[erythromycin]] administration. Therefore, caution should be exercised when [[erythromycin]] is administered to a nursing woman. | ||
|useInPed=Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established. | |useInPed=Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established. | ||
|administration=Applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. | |administration=Applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. | ||
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|IVCompat=There is limited information about the IV Compatibility. | |IVCompat=There is limited information about the IV Compatibility. | ||
|overdose=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding overdose. | |overdose=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding overdose. | ||
|mechAction=The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. | |mechAction=The exact mechanism by which [[erythromycin]] reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. | ||
Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. | Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. | ||
|structure= | |structure=Erythromycin/Benzoyl Peroxide® Topical Gel contains [[erythromycin]] [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[ [3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. [[erythromycin]] is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. | ||
Chemically, erythromycin is (C37H67NO13). It has the following structural formula: | Chemically, [[erythromycin]] is (C37H67NO13). It has the following structural formula: | ||
[[File:Erythromycin Benzoyl Peroxide_structure_01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | [[File:Erythromycin Benzoyl Peroxide_structure_01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | ||
[[erythromycin]] has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. | |||
Erythromycin/Benzoyl Peroxide Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. | |||
Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula: | Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula: | ||
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Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown. | Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown. | ||
No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet. | No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical [[erythromycin]]. However, long-term (2-year) oral studies in rats with[[erythromycin]] ethylsuccinate and [[erythromycin]] base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed [[erythromycin]] (base) at levels up to 0.25% of diet. | ||
|clinicalStudies=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Clinical Studies. | |clinicalStudies=FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Clinical Studies. | ||
|howSupplied=[[File:Erythromycin Benzoyl Peroxide_how supplied_01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | |howSupplied=[[File:Erythromycin Benzoyl Peroxide_how supplied_01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | ||
Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). | Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve [[erythromycin]]. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin/Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. | ||
|storage=Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F). | |storage=Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F). | ||
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Do not freeze. Keep tightly closed. Keep out of the reach of children. | Do not freeze. Keep tightly closed. Keep out of the reach of children. | ||
|fdaPatientInfo=Patients using | |fdaPatientInfo=Patients using Erythromycin/Benzoyl Peroxide Topical Gel should receive the following information and instructions: | ||
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes. | This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes. | ||
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Patients should not use any other topical acne preparation unless otherwise directed by physician. | Patients should not use any other topical acne preparation unless otherwise directed by physician. | ||
Patients should report to their physician any signs of local adverse reactions. | Patients should report to their physician any signs of local adverse reactions. | ||
Erythromycin/Benzoyl Peroxide® Topical Gel may bleach hair or colored fabric. | |||
|alcohol=Alcohol-Erythromycin/Benzoyl Peroxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Erythromycin/Benzoyl Peroxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
|brandNames= | |brandNames=Erythromycin/Benzoyl Peroxide Pak | ||
|lookAlike=Therer is limited information about the look alike drug names. | |lookAlike=Therer is limited information about the look alike drug names. | ||
}} | }} | ||
Revision as of 17:22, 24 September 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Disclaimer
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Overview
Erythromycin/Benzoyl Peroxide is a Macrolide that is FDA approved for the {{{indicationType}}} of acne vulgaris. Common adverse reactions include Application site reaction, Dry skin, Urticaria.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acne Vulgaris
- Dosing information
- Erythromycin/Benzoyl Peroxide Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin/Benzoyl Peroxide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin/Benzoyl Peroxide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin/Benzoyl Peroxide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin/Benzoyl Peroxide in pediatric patients.
Contraindications
Erythromycin/Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis."
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficult colitis.
Adverse Reactions
Clinical Trials Experience
In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin/Benzoyl Peroxide Topical Gel was approximately 3%. These were dryness and urticarial reaction.
The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported.
Postmarketing Experience
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding postmarketing experience.
Drug Interactions
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Drug Interaction.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C Animal reproduction studies have not been conducted with Erythromycin/Benzoyl Peroxide Topical Gel or benzoyl peroxide.
There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters.
There are no well-controlled trials in pregnant women with Erythromycin/Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin/Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin/Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Erythromycin/Benzoyl Peroxide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Erythromycin/Benzoyl Peroxide during labor and delivery.
Nursing Mothers
It is not known whether Erythromycin/Benzoyl Peroxide Topical Gel is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
Geriatic Use
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide in geriatric settings.
Gender
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Erythromycin/Benzoyl Peroxide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Erythromycin/Benzoyl Peroxide in patients who are immunocompromised.
Administration and Monitoring
Administration
Applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
Monitoring
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Drug Monitoring.
IV Compatibility
There is limited information about the IV Compatibility.
Overdosage
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding overdose.
Pharmacology
There is limited information regarding Erythromycin/Benzoyl Peroxide Pharmacology in the drug label.
Mechanism of Action
The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug.
Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
Structure
Erythromycin/Benzoyl Peroxide® Topical Gel contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[ [3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.
Chemically, erythromycin is (C37H67NO13). It has the following structural formula:
erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C.
Erythromycin/Benzoyl Peroxide Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent.
Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula:
Pharmacodynamics
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Pharmacodynamics.
Pharmacokinetics
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Pharmacokinetics.
Nonclinical Toxicology
CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY
Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown.
No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats witherythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
Clinical Studies
FDA Package Insert for Erythromycin/Benzoyl Peroxide contains no information regarding Clinical Studies.
How Supplied
Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin/Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label.
Storage
Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F).
After reconstitution, store under refrigeration between 2° and 8°C (36° – 46°F).
Do not freeze. Keep tightly closed. Keep out of the reach of children.
Images
Drug Images
{{#ask: Page Name::Erythromycin/Benzoyl Peroxide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Erythromycin/Benzoyl Peroxide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
Patients using Erythromycin/Benzoyl Peroxide Topical Gel should receive the following information and instructions:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes. This medication should not be used for any disorder other than that for which it was prescribed. Patients should not use any other topical acne preparation unless otherwise directed by physician. Patients should report to their physician any signs of local adverse reactions. Erythromycin/Benzoyl Peroxide® Topical Gel may bleach hair or colored fabric.
Precautions with Alcohol
Alcohol-Erythromycin/Benzoyl Peroxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Erythromycin/Benzoyl Peroxide Pak
Look-Alike Drug Names
Therer is limited information about the look alike drug names.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
{{#subobject:
|Label Page=Erythromycin/Benzoyl Peroxide |Label Name=Erythromycin Benzoyl Peroxide_label_01.jpg
}}
{{#subobject:
|Label Page=Erythromycin/Benzoyl Peroxide |Label Name=Erythromycin Benzoyl Peroxide_panel_01.png
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