erythromycin topical/benzoyl peroxide (Benzamycin, Benzamycin Pak)

Dosing and uses of Benzamycin, Benzamycin Pak (erythromycin topical/benzoyl peroxide)

• Adult
• Pediatric

 

Adult dosage forms and strengths

erythromycin topical/benzoyl peroxide

topical geL

• 3%/5%

 

Acne Vulgaris

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

 

Administration

Benzamycin Pak: Requires thorough mixing by the patient immediately prior to each use; may store at room temperature

Benzamycin: After reconstitution; store refrigerated between 2-8°C (36-46°F); do not freeze

 

Pediatric dosage forms and strengths

erythromycin topical/benzoyl peroxide

topical geL

• 3%/5%

 

Acne Vulgaris

<12 years: Safety and efficacy not established

≥12 years: Apply topically BID (morning and evening) to affected areas after skin is thoroughly washed and patted dry

 

Administration

Benzamycin Pak: Requires thorough mixing by the patient immediately prior to each use; may store at room temperature

Benzamycin: After reconstitution; store refrigerated between 2-8°C (36-46°F); do not freeze

 

Benzamycin, Benzamycin Pak (erythromycin topical/benzoyl peroxide) adverse (side) effects

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%)

 

Warnings

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 and lactation

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.

 

Pharmacology of Benzamycin, Benzamycin Pak (erythromycin topical/benzoyl peroxide)

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