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Erythromycin (Topical)


VA CLASSIFICATION
Primary: DE752
Secondary: DE101{08}

Commonly used brand name(s): A/T/S; Akne-Mycin; ETS; Emgel; Ery-Sol; EryDerm; Erycette; Erygel; Erymax; Erythra-Derm; Sans-Acne; Staticin; T-Stat; Theramycin Z.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiacne agent (topical)—Erythromycin Ointment; Erythromycin Pledgets; Erythromycin Topical Gel{05}; Erythromycin Topical Solution.;

Antibacterial (topical)—Erythromycin Ointment.{01};

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Acne vulgaris (treatment)—Topical erythromycin is indicated in the topical treatment of acne vulgaris. It may be effective in grades II and III acne, which are characterized by inflammatory lesions such as papules and pustules. Topical antibacterials are not generally considered to be as effective as systemic antibacterials in the treatment of acne, especially more severe inflammatory acne. {18}

[Skin infections, bacterial, minor (prophylaxis)]1or
[Skin infections, bacterial, minor (treatment)]1—Erythromycin ointment is used in the topical prophylaxis and treatment of superficial pyogenic infections of the skin. {01} {25}

Unaccepted
Topical erythromycin is not effective in deep cystic lesions or in noninflammatory lesions.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    733.94

Mechanism of action/Effect:

Antiacne agent (topical)—Probably due to its antibacterial activity. Topical erythromycin is thought to suppress the growth of Propionibacterium acnes (Corynebacterium acnes) , an anaerobe found in sebaceous glands and follicles. {19} P. acnes produces proteases, hyaluronidases, lipases, and chemotactic factors, all of which can produce inflammatory components or inflammation directly.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to one erythromycin may be sensitive to other erythromycins also.

Carcinogenicity


For erythromycin pledgets; erythromycin topical gel; erythromycin topical solution:

Long-term studies in animals have not been done to evaluate carcinogenicity. {05} {06} {07} {18} {21} {22}


Mutagenicity


For erythromycin pledgets; erythromycin topical gel:

Long-term studies in animals have not been done to evaluate mutagenicity. {05} {06} {21} {22}



For erythromycin topical solution:

Erythromycin topical solution has not been shown to be mutagenic in the Ames Salmonella/Microsome Plate Test. {07} {18}


Pregnancy/Reproduction

Pregnancy—

For erythromycin pledgets


Fertility; pregnancy—

Studies have not been done in humans or animals.

FDA Pregnancy Category C. {06} {23}




For erythromycin topical gel; erythromycin topical solution


Fertility; pregnancy—

Erythromycin crosses the placenta, although fetal serum concentrations are generally low. Adequate and well-controlled studies in humans have not been done.

Studies in rats, fed erythromycin base in amounts up to 0.25% of their diet prior to and during mating, during gestation, and through weaning, have not shown that erythromycin causes adverse effects on the fetus. {22} In addition, studies in rats and rabbits, given 1.5, 4, and 13 times the estimated human dose, have not shown that erythromycin causes impaired fertility or adverse effects on the fetus.

FDA Pregnancy Category B. {05} {07} {18}



Breast-feeding


For erythromycin pledgets; erythromycin topical gel:

It is not known whether erythromycin, applied topically, is distributed into breast milk. Erythromycin, given systemically, is distributed into breast milk. However, problems in humans have not been documented. {05} {06} {22}


Pediatrics


For erythromycin topical gel:

Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the pediatric population. {22}



For erythromycin topical solution:

Appropriate studies on the relationship of age to the effects of this medicine have not been performed in children up to 12 years of age. {18}



Geriatrics


Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Abrasive or medicated soaps or cleansers or
Acne preparations or preparations containing a peeling agent, such as:
Benzoyl peroxide
Resorcinol
Salicylic acid
Sulfur
Tretinoin or
Alcohol-containing preparations, topical, such as:
After-shave lotions
Astringents
Perfumed toiletries
Shaving creams or lotions or
Cosmetics or soaps with a strong drying effect or
Isotretinoin or
Medicated cosmetics or ``cover-ups''    (concurrent use with erythromycin pledgets, topical gel, or topical solution may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin {25})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to erythromycin


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
For ointment {24}
Incidence less frequent
    
Peeling
    
redness


For pledgets, topical gel, and topical solution {18} {21} {22}
Incidence more frequent
    
Dry or scaly skin
    
irritation
    
itching
    
stinging or burning feeling

Incidence less frequent
    
Peeling
    
redness






Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Erythromycin (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to erythromycins

Pregnancy—Erythromycin crosses the placenta





Breast-feeding—Erythromycin enters breast-milk

Proper use of this medication
Proper administration technique

» Compliance with full course of therapy, which may take months or longer

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

For pledgets, topical gel, and topical solution
» Not using near heat or open flame or while smoking

Not using medication more often than prescribed

Avoiding too frequent washing of affected areas

» Importance of applying medication to entire affected area

» Not using in eyes, nose, mouth, or on other mucous membranes

Precautions while using this medication
Checking with physician if no improvement in acne within 3 to 4 weeks; may take up to 8 to 12 weeks before full therapeutic benefit is seen

For pledgets, topical gel, and topical solution
Waiting at least 1 hour before applying any other topical medication for acne

Possibility of stinging or burning after application

Checking with physician if treated skin becomes excessively dry

Proper use of cosmetics


General Dosing Information

For topical solution dosage form
If the treated area(s) become uncomfortable because of excessive dryness or irritation, the dosage of erythromycin topical solution may be reduced to once a day or less often until the symptoms have subsided.

In the treatment of acne with erythromycin topical solution, noticeable improvement may be seen in 3 to 4 weeks. However, 8 to 12 weeks of treatment may be required before maximum benefit is seen.


Topical Dosage Forms

ERYTHROMYCIN OINTMENT USP

Note: The composition of Akne-Mycin available in the U.S. is different from that of Akne-Mycin available in Europe. {24}


Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, two times a day, morning and evening. {24}


Usual pediatric dose
See Usual adult and adolescent dose. {24}

Strength(s) usually available
U.S.—


2% (Rx) [Akne-Mycin{24}{38}]

Canada—
Not commercially available.

Packaging and storage:
Store preferably between 15 and 30 °C (59 and 86 °F). Store in a collapsible tube or in another tight container. Protect from freezing. {24}

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.


ERYTHROMYCIN PLEDGETS USP

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, two times a day. {21}


Usual pediatric dose
See Usual adult and adolescent dose. {21}

Strength(s) usually available
U.S.—


2% (Rx) [Erycette{35} (alcohol 66%) (propylene glycol)] [T-Stat ( alcohol 71.2%) (propylene glycol)]{17}{21}

Canada—
Not commercially available.

Note: Supplied as foil-covered pledgets (swabs) saturated with 2% erythromycin topical solution.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. {21}

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Flammable—Keep from heat and flame.


ERYTHROMYCIN TOPICAL GEL

Usual adult and adolescent dose
See Erythromycin Ointment USP. {22}

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


2% (Rx) [A/T/S{32} (alcohol 92%)] [Emgel{45}] [Erygel{34} (alcohol 92%)]{22}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {18}

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Flammable—Keep from heat and flame.


ERYTHROMYCIN TOPICAL SOLUTION USP

Usual adult and adolescent dose
See Erythromycin Ointment USP. {18}

Usual pediatric dose
Infants and children up to 12 years of age—Dosage has not been established. {07} {18}

Children 12 years of age and over—See Usual adult and adolescent dose . {18}

Strength(s) usually available
U.S.—


1.5% (Rx) [Staticin{42}{44} (alcohol 55%) (propylene glycol)][Generic]


2% (Rx) [Akne-Mycin{38} (alcohol 66%) (propylene glycol)] [A/T/S ( alcohol 66%) (propylene glycol)] [EryDerm ( alcohol 77%) (propylene glycol)] [Erymax{33} (alcohol 66%) ( propylene glycol)] [Ery-Sol] [Erythra-Derm (erythromycin base){47}] [ETS{36} (alcohol 66%) (propylene glycol)] [Theramycin Z{46}] [T-Stat{37} (alcohol 71.2%) (propylene glycol)][Generic]{13}{14}{15}{17}{18}{21}{27}{28}{30}

Canada—


1.5% (Rx) [Staticin{42}{44} ( alcohol 55%)]


2% (Rx) [Sans-Acne{31}{43} ( alcohol 44%)]{09}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • For external use only.
   • Continue medication for full time of treatment.
   • Keep container tightly closed.
   • Flammable—Keep from heat and flame.

Note: Explain administration technique.




Revised: 09/18/2000



References
  1. Indications Index review, 1986.
  1. Ilotycin Ophthalmic pkg insert, Dista (U.S.), PDR 1986: 840.
  1. Ilotycin Tablets pkg insert, Dista (U.S.), PDR 1986: 840-841.
  1. Panel comments, Erythromycin (Topical), 9/13/85.
  1. Erygel pkg insert, Herbert Labs (U.S.), 9/87 (rec"d 12/3/87).
  1. Erycette pkg insert, Ortho (U.S.), PDR 1988: 1513.
  1. T-Stat Topical Solution pkg insert, Westwood (U.S.), PDR 1988: 2211-2212.
  1. USP DI 1989, VA Medication Classification System: 2472.
  1. CPS 1988, Staticin (Westwood): 866.
  1. Redbook 1989, ATS (Hoechst): 111.
  1. Redbook 1989, Akne-Mycin (Hermal): 126.
  1. Redbook 1989, ETS (Paddock), p 304.
  1. Redbook 1989, Erycette (Ortho), Eryderm (Abbott), Erygel (Herbert), Erymax (Herbert), Erysol (Dermol Pharm): 314.
  1. Redbook 1989, Erythromycin solution (generic): 316-317.
  1. Redbook 1989, Mythromycin (My-K): 493.
  1. Redbook 1989, Staticin (Westwood): 651.
  1. Pharmindex, 11/88, T-Stat: 7.
  1. Package insert, Staticin (Westwood), Rev 85, Rec 2/89.
  1. USAN 1989: 215.
  1. USP Description and Solubility, 4/3/89.
  1. PDR 1989, Erycette (Ortho): 1515.
  1. PDR 1989, Erygel (Herbert): 1016.
  1. PDR 1989, T-Stat (Westwood): 2225.
  1. Package insert, Akne-Mycin Ointment (Hermal), Rev 9/84, Rec 2/85.
  1. AHFS 1988: 1976-1978.
  1. USP Requirements, USP DI 1989, IV/34.
  1. Package insert, Akne-Mycin Solution (Hermal), Rev 9/84, Rec 3/85.
  1. PDR 1989, Eryderm (Abbott): 519.
  1. PDR 1989, Erymax (Herbert): 1016.
  1. PDR 1989, ETS-2% (Paddock): 1522.
  1. PI (Canada) - Sans-Acne, Alcon: Sent monograph in French 2/90, issued 2/89.
  1. A/T/S 2% solution with 66% alcohol, & gel, with 92% alcohol, Hoechst-Roussel PDR-92: 1089.
  1. Erymax 2% solution, 66% SD alcohol 40-2, Herbert. PDR-92: 1082.
  1. Erygel 2% gel, 92% alcohol, Herbert. PDR-92: 1082.
  1. Erycette 2% pledgets, 66% alcohol, Ortho. PDR-92: 1678.
  1. ETS 2% solution, 66% alcohol, Paddock. PDR-92: 1685.
  1. T-Stat 2% solution and pads, each with 71.2% alcohol, Westwood-Squibb. PDR-92: 2409.
  1. Akne-Mycin 2% solution & ointment, Hermal. RedBook 1992.
  1. EryDerm 2% solution, Abbott. RedBook 1992.
  1. Ery-Sol 2% solution, Dermol. RedBook 1992.
  1. Staticin, 1.5% solution, Westwood-Squibb. RedBook 1992.
  1. Sans-Acne 2% solution, 44% ethyl alcohol, Galderma. CPS-91.
  1. Staticin 1.5% solution, 55% ethyl alcohol, Westwood-Squibb. CPS-91.
  1. Product Information: Emgel®, erythromycin 2% gel. Glaxo Wellcome, Research Triangle Park, NC, (PI revised 9/1996) reviewed 9/2000.
  1. Product Information: Theramycin Z®, erythromycin 2% solution. Medicis, Scottsdale, AZ, reviewed 9/2000.
  1. Product Information: Erythra-Derm®, erythromycin 2% solution. Paddock, Minneapolis, MN, reviewed 9/2000.
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