ERYTHROMYCIN 2% GEL (Generic Erygel)

Uses Dosage and Administration Cautions Drug Interactions Pharmacokinetics

Uses

Acne Vulgaris

Erythromycin is used topically in the treatment of acne vulgaris. Therapy of acne vulgaris must be individualized and frequently modified depending on the types of acne lesions which predominate and the response to therapy. Topical anti-infectives, including erythromycin, are generally effective in the treatment of mild to moderate inflammatory acne. However, use of topical anti-infectives as monotherapy may lead to bacterial resistance; this resistance is associated with decreased clinical efficacy.

Topical erythromycin is particularly useful when used with benzoyl peroxide or topical retinoids. Results of clinical studies indicate that combination therapy results in a reduction in total lesion counts of 50 to 70%.

Skin Infections

Although erythromycin was previously available for topical use in the treatment of superficial infections of the skin caused by susceptible bacteria, minor skin infections and wounds usually heal without treatment, and systemic anti-infective therapy is required for the treatment of serious or extensive skin infections such as impetigo. The currently available erythromycin ointment is intended for topical use in the treatment of inflammatory acne and not for the treatment of superficial infections of the skin. The US Food and Drug Administration (FDA) advisory panel on over-the-counter antimicrobial drugs has concluded that there is a lack of substantial evidence to demonstrate that topical anti-infectives, including topical erythromycin, are effective as skin wound anti-infectives. In addition, most clinicians state that indiscriminate use of topical erythromycin may result in the emergence of organisms resistant to the drug.

For other uses of erythromycin, see 8:12.12.04 and 52:04.04.

Dosage and Administration

Acne Vulgaris

For the topical treatment of acne vulgaris, erythromycin has been applied to the skin in the form of a solution, gel, or ointment. The solution, gel, or ointment should be applied to all areas of skin prone to acne. A thin film of one of the commercially available erythromycin 2% solutions, 2% gel, or 2% ointment should be applied to the cleansed, affected area each morning and/or evening. When pledgets saturated with an erythromycin 2% solution are used, several pledgets may be necessary with each application depending on the size of the affected area. Maintenance therapy is needed to prevent recurrence.

Cautions

Adverse Effects

Erythromycin has a low order of toxicity. Sensitivity reactions rarely occur following topical application of the drug. Generalized urticaria, which required treatment with systemic corticosteroids, has been reported in a few patients following topical use of erythromycin.

The most frequent adverse reaction to erythromycin topical solutions is local dryness. Erythema, tenderness, burning, pruritus, oiliness, and desquamation have also been reported following topical application of erythromycin solutions or gel. Most of these reactions appear to be caused by the alcohol or other ingredients in commercially available solutions or gel of the drug rather than erythromycin. Irritation of the eye has been reported with topical erythromycin solutions or gel. Skin irritation, such as erythema and peeling, has occasionally been reported with topical application of erythromycin ointment for acne. At least one case of contact dermatitis has been reported following topical application of the ointment for acne, but a causal relationship to the ointment has not been established. A generalized urticarial reaction, which required systemic corticosteroid therapy and possibly was causally related to erythromycin, has been reported during topical use of the gel.

Precautions and Contraindications

Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with the use of erythromycin. CDAD should be considered in the differential diagnosis of patients who develop diarrhea during or following anti-infective therapy. Mild cases of colitis may respond to discontinuance of the drug alone. If colitis is severe or is not relieved by discontinuance of the drug, appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) should be administered.

Topical use of erythromycin may result in overgrowth of nonsusceptible organisms including fungi. Gram-negative folliculitis has been reported rarely following topical use of erythromycin in the treatment of acne vulgaris. If superinfection or suprainfection occurs during erythromycin therapy, the drug should be discontinued and appropriate therapy instituted.

Erythromycin topical solutions, including a solution available as saturated pledgets, topical gel, and topical ointments are for external use only and should not be used near the eyes, nose, mouth, or other mucous membranes.

Erythromycin topical preparations are contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulations.

Pregnancy and Lactation

Pregnancy

Safe use of erythromycin topical preparations during pregnancy has not been established.

Lactation

Safe use of erythromycin topical preparations during lactation has not been established.

Drug Interactions

Topical acne preparations containing peeling, desquamating, or abrasive agents (e.g., benzoyl peroxide, tretinoin, salicylic acid, sulfur) should be used cautiously in patients using topical anti-infectives because a cumulative irritant effect could occur. In addition, information on the physical and/or chemical compatibility of topical anti-infectives and other topical acne preparations is not available. Concurrent use of abrasive or medicated soaps or cosmetic products containing alcohol (e.g., astringents, after-shave lotions) may also cause a cumulative irritant or drying effect in patients using topical anti-infectives.

Because of possible competitive binding for the 50S ribosomal subunit (see Mechanism of Action), erythromycin and clindamycin probably should not be used concomitantly.

Pharmacokinetics

In an in vitro model using human skin, erythromycin was absorbed into the stratum corneum following topical application of 10-20 mg of the drug in a vehicle containing dimethylacetamide and 95% alcohol. The drug does not appear to be absorbed systemically following twice daily application of a 2% solution of the drug in a vehicle containing 77% alcohol and polyethylene glycol and acetone.

It is not known if erythromycin is absorbed from intact or denuded skin, wounds, or mucous membranes following topical application of an ointment containing the drug.

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