erythromycin topical/benzoyl peroxide (Rx)

1-10%

Dry skin (5-7.6%)

Application site reaction (stinging, erythema, burning) (0.8-2.5%)

Blepharitis (1.7%)

Pruritus (1.7-2.5%)

Photosensitivity (1.3%)

<1%

Skin peeling (<0.5%)

Contraindications

Hypersensitivity

Cautions

For external use only; avoid contact with eyes and other mucous membranes

Concomitant topical acne therapy may result in cumulative irritation, especially with the use of peeling, desquamating, or abrasive agents; if this occurs, discontinue and seek medical advice

Although limited systemic absorption occurs with topical erythromycin, antibiotics may be associated with the overgrowth of nonsusceptible organisms; if this occurs, discontinue use and contact physician

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

The exact mechanism by which erythromycin and benzoyl peroxide reduce lesions of acne vulgaris is not fully known

Erythromycin: Inhibits protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis

Benzoyl peroxide: Elicits action by releasing active oxygen; effective in vitro against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones; also elicits a keratolytic and desquamative effect which may also contribute to its efficacy

Pharmacokinetics

Benzoyl peroxide absorbed by the skin where it is converted to benzoic acid

Topical Preparation

Benzamycin Pak, Aktipak

• Each foil pouch contains the 2 medications in separated compartments
• The content must be mixed thoroughly by the patient, in the palm of the hand, prior to application
• Apply immediately after mixing, then wash hands

Benzamycin

• 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 benzoyl peroxide gel and stir until homogeneous in appearance (60-90 seconds)

Topical Administration

Apply topically BID (morning and evening) to affected areas after skin is thoroughly washed and patted dry

May bleach hair or colored fabric

Excessive or prolonged exposure to sunlight should be limited; to minimize exposure to sunlight, a hat or other clothing should be worn

For external use only; avoid contact with the eyes, mouth, and all mucous membranes as this product may be irritating

Storage

Benzamycin Pak, Aktipak: Store at room temperature between 20-25°C (68-77°F); keep away from heat and any open flame

Benzamycin

• Before reconstitution: Store at room temperature between 15-30°C (59-86°F)
• After reconstitution: Store refrigerated between 2-8°C (36-46°F)
• Do not freeze
• Keep tightly closed