Erythromycin (topical): Difference between revisions

Jump to navigation Jump to search
VisualWikitext
(Created page with "{{DrugProjectFormSinglePage |authorTag= {{AV}} <!--Overview--> |genericName=Erythromycin (topical) |aOrAn= an |drugClass=antibacterial |indication=acne vulgari...")
 
m (Protected "Erythromycin (topical)": Bot: Protecting all pages from category Drug ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite)))
 
(3 intermediate revisions by one other user not shown)
Line 1: Line 1:
{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=
|authorTag={{AV}}<!--Overview-->
{{AV}}
 
<!--Overview-->
 
|genericName=Erythromycin (topical)
|genericName=Erythromycin (topical)
 
|aOrAn=an
 
 
|aOrAn=
 
an
 
|drugClass=[[antibacterial]]
|drugClass=[[antibacterial]]
 
|indicationType=treatment
 
 
|indication=[[acne vulgaris]]
|indication=[[acne vulgaris]]
|hasBlackBoxWarning=
|adverseReactions=[[nausea]], [[vomiting]], [[abdominal pain]], [[diarrhea]] and [[anorexia]]
|adverseReactions=[[nausea]], [[vomiting]], [[abdominal pain]], [[diarrhea]] and [[anorexia]]


Line 29: Line 11:


<!--Black Box Warning-->
<!--Black Box Warning-->
 
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
Line 41: Line 19:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=*Erythromycin Topical Solution, USP 2% is indicated for the topical treatment of [[acne vulgaris]].
|fdaLIADAdult=
*Erythromycin Topical Solution, USP 2% is indicated for the topical treatment of [[acne vulgaris]].
====Dosage====
====Dosage====


Line 52: Line 28:


<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=
 
 
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=* Erythromycin Topical Solution, USP 2% is contraindicated in those individuals who have shown [[hypersensitivity]] to any of its components.
|contraindications=
 
* Erythromycin Topical Solution, USP 2% is contraindicated in those individuals who have shown [[hypersensitivity]] to any of its components.


<!--Warnings-->
<!--Warnings-->
 
|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]]".
Line 121: Line 67:


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
 
|clinicalTrials=*The following additional local adverse reactions have been reported occasionally:
|clinicalTrials=
 
*The following additional local adverse reactions have been reported occasionally:


*peeling, dryness, [[itching]], [[erythema]], and oiliness. Irritation of the eyes and tenderness of the skin have been reported with topical use of erythromycin. Generalized [[urticarial]] reactions, possibly related to the use of erythromycin, which required systemic [[steroid]] therapy have been reported.
*peeling, dryness, [[itching]], [[erythema]], and oiliness. Irritation of the eyes and tenderness of the skin have been reported with topical use of erythromycin. Generalized [[urticarial]] reactions, possibly related to the use of erythromycin, which required systemic [[steroid]] therapy have been reported.


<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
 
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.




<!--Drug Interactions-->
<!--Drug Interactions-->
 
|drugInteractions=<!--Use in Specific Populations-->
|drugInteractions=
|FDAPregCat=B
 
|useInPregnancyFDA=*Teratogenic Effects
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
*Teratogenic EffectsPregnancy Category B
 
*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, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. *Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.
*There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.  
|useInPregnancyAUS=
*Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.
 
|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInNursing=*It is not known whether erythromycin 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 have not been established.
|useInLaborDelivery=
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInNursing=
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment.]]
*It is not known whether erythromycin 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.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment.]]
|useInPed=
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
*Safety and effectiveness of this product in pediatric patients have not been established.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]].
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment.]]
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment.]]
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]].


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
 
|administration=*Topical
|administration=
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
*Topical
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.




<!--IV Compatibility-->
<!--IV Compatibility-->
 
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
<!--Overdosage-->
 
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
|overdose=
 
 
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->


<!--Drug box 2-->
<!--Drug box 2-->
|drugBox={{drugbox2
|drugBox={{drugbox2


Line 320: Line 219:


<!--Mechanism of Action-->
<!--Mechanism of Action-->
 
|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.


=====Microbiology=====
=====Microbiology=====
Line 329: Line 225:
*Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting [[translocation]] of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, [[lincomycin]], [[chloramphenicol]], and [[clindamycin]].
*Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting [[translocation]] of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, [[lincomycin]], [[chloramphenicol]], and [[clindamycin]].
<!--Structure-->
<!--Structure-->
 
|structure=* Erythromycin Topical Solution, USP 2% 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), for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.
|structure=
 
* Erythromycin Topical Solution, USP 2% 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), for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora 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:
Line 341: Line 234:
*Each mL of Erythromycin Topical Solution, USP 2% contains 20 milligrams of erythromycin in a base of alcohol, USP (66.0%) and propylene glycol, USP.
*Each mL of Erythromycin Topical Solution, USP 2% contains 20 milligrams of erythromycin in a base of alcohol, USP (66.0%) and propylene glycol, USP.
<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
 
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
 
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
 
|nonClinToxic=*Carcinogenesis, Mutagenesis, Impairment of Fertility
|nonClinToxic=
 
*Carcinogenesis, Mutagenesis, Impairment of Fertility
:*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.
<!--Clinical Studies-->
<!--Clinical Studies-->
 
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
<!--How Supplied-->
 
|howSupplied=* Erythromycin Topical Solution, USP 2% is supplied as follows:
|howSupplied=
 
* Erythromycin Topical Solution, USP 2% is supplied as follows:
:*60 mL bottle with applicator NDC 60432-671-60
:*60 mL bottle with applicator NDC 60432-671-60
*Store in a dry place at temperatures between 15 °–25 °C (59 °–77 °F) [See USP Controlled Room Temperature].
*Store in a dry place at temperatures between 15 °–25 °C (59 °–77 °F) [See USP Controlled Room Temperature].
*KEEP TIGHTLY CLOSED
*KEEP TIGHTLY CLOSED
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
 
|fdaPatientInfo=*Patients using Erythromycin should receive the following information and instructions:
|fdaPatientInfo=
 
*Patients using Erythromycin 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.
:*This medication should not be used for any disorder other than that for which it was prescribed.
:*This medication should not be used for any disorder other than that for which it was prescribed.
Line 382: Line 257:
*Patients should report to their physician any signs of local adverse reactions.
*Patients should report to their physician any signs of local adverse reactions.
<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|brandNames=
|brandNames=
*
<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
 
|lookAlike=<!--Drug Shortage Status-->
|lookAlike=
 
<!--Drug Shortage Status-->
 
|drugShortage=
|drugShortage=
}}
}}
<!--Pill Image-->
<!--Pill Image-->


Latest revision as of 20:32, 18 August 2015

Erythromycin (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Erythromycin (topical) is an antibacterial that is FDA approved for the treatment of acne vulgaris. Common adverse reactions include nausea, vomiting, abdominal pain, diarrhea and anorexia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Erythromycin Topical Solution, USP 2% is indicated for the topical treatment of acne vulgaris.

Dosage

  • Erythromycin Topical Solution, USP 2% should be applied to the affected area 2 times a day (morning and evening) after the skin is thoroughly washed with warm water and soap and patted dry. Moisten the applicator or a pad with erythromycin, then rub over the affected area. Acne lesions on the face, neck, shoulder, chest and back may be treated in this manner.
  • This medication should be applied with applicator top. If fingertips are used, wash hands after application. Drying and peeling may be controlled by reducing the frequency of applications.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Erythromycin (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin (topical) in pediatric patients.

Contraindications

  • Erythromycin Topical Solution, USP 2% 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.
  • 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. difficile colitis.

Precautions

  • For topical use only; not for ophthalmic use. 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.
  • The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures.
  • Avoid contact with eyes and all mucous membranes.

Adverse Reactions

Clinical Trials Experience

  • The following additional local adverse reactions have been reported occasionally:
  • peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have been reported with topical use of erythromycin. Generalized urticarial reactions, possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Erythromycin (topical) in the drug label.

Drug Interactions

There is limited information regarding Erythromycin (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Teratogenic Effects
  • 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, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
  • Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Erythromycin (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Erythromycin (topical) during labor and delivery.

Nursing Mothers

  • It is not known whether erythromycin 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 have not been established.

Geriatic Use

There is no FDA guidance on the use of Erythromycin (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Erythromycin (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Erythromycin (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Erythromycin (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Erythromycin (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Erythromycin (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Erythromycin (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Erythromycin (topical) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Erythromycin (topical) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Erythromycin (topical) in the drug label.

Pharmacology

Template:Px
Template:Px
Erythromycin (topical)
Systematic (IUPAC) name
(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-
{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-
14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-
5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-
3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione
Identifiers
CAS number 114-07-8
ATC code D10AF02 J01FA01 (WHO) S01AA17 (WHO) Template:ATCvet
PubChem 3255
DrugBank DB00199
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 733.93 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Depends on the ester type between 30% - 65%
Protein binding 90%
Metabolism liver (under 5% excreted unchanged)
Half life 1.5 hours
Excretion bile
Therapeutic considerations
Pregnancy cat.

A(AU) B(US)

Legal status

Prescription Only (S4)(AU) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes oral, iv, im, topical, ophthalmic eye drops

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.
Microbiology
  • Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.

Structure

  • Erythromycin Topical Solution, USP 2% 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), for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.
  • Chemically, Erythromycin is C37H67NO13. It has the following structural formula:
This image is provided by the National Library of Medicine.
  • Erythromycin has the molecular weight of 733.94. It is a white or slightly yellow, crystalline powder and it is slightly soluble in water; soluble in alcohol, in chloroform and in ether.
  • Each mL of Erythromycin Topical Solution, USP 2% contains 20 milligrams of erythromycin in a base of alcohol, USP (66.0%) and propylene glycol, USP.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Erythromycin (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Erythromycin (topical) in the drug label.

Nonclinical Toxicology

  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • 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.

Clinical Studies

There is limited information regarding Clinical Studies of Erythromycin (topical) in the drug label.

How Supplied

  • Erythromycin Topical Solution, USP 2% is supplied as follows:
  • 60 mL bottle with applicator NDC 60432-671-60
  • Store in a dry place at temperatures between 15 °–25 °C (59 °–77 °F) [See USP Controlled Room Temperature].
  • KEEP TIGHTLY CLOSED

Storage

There is limited information regarding Erythromycin (topical) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Erythromycin (topical) |?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 (topical) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • Patients using Erythromycin 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 medication unless otherwise directed by their physician.
  • Patients should report to their physician any signs of local adverse reactions.

Precautions with Alcohol

  • Alcohol-Erythromycin (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Erythromycin (topical) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Erythromycin (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.



{{#subobject: 

 |Label Page=Erythromycin (topical)
 |Label Name=Erythromycin (topical)02.png

}}


{{#subobject: 

 |Label Page=Erythromycin (topical)
 |Label Name=Erythromycin (topical)03.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Erythromycin_(topical)&oldid=1135287"