ERYACNE

Erythromycin

Presentation
ERYACNE 2% GEL contains 20mg/g of erythromycin in an alcohol gel.
ERYACNE 4% GEL contains 40mg/g of erythromycin in an alcohol gel.
Erythromycin is a mixture of macrolide antibiotics. It is colourless or slightly yellow and is slightly soluble in water and freely soluble in alcohol. Hydroxypropylcellulose is used as a gelling agent. Butylhydroxytoluene is used as an anti-oxidant. The gel is colourless and transparent with a soft feel.

Actions
Erythromycin has in vitro activity against a number of aerobic and anaerobic Gram-positive bacteria as well as some Gram-negative bacilli. Erythromycin inhibits protein synthesis in susceptible bacteria by reversibly binding to the 50S ribosomal subunits.
Following topical application to the skin, erythromycin significantly inhibits the growth of Propionibacterium acnes on the surface of the skin and reduces the concentration of free fatty acids in the sebum.
In vitro and animal studies show that erythromycin has anti-inflammatory properties.
In clinical use of topical erythromycin strains of Propionibacterium acnes resistant to erythromycin were reported in about 20% of subjects. The resistant organisms recovered were also resistant to clindamycin.

Pharmacokinetics
Percutaneous absorption studies in animals show very low absorption of erythromycin. In one clinical study, the penetration of topical erythromycin to lower skin layers suggested that systemic absorption may be low but no definitive bioavailability study has been conducted with ERYACNE. It is not known whether erythromycin is absorbed from denuded skin, wounds or mucous membranes.

Indications
Eryacne is indicated for the treatment of mild to moderate acne vulgaris.

Dosage and Administration
Wash the affected area with a mild non-alkaline soap. Rinse thoroughly and pat dry. A thin film of ERYACNE should be applied to the cleansed, affected areas twice daily. Allow to dry for a couple of minutes to prevent the gel from being wiped off. Replace the cap tightly after use.
As a rule, an 8 week treatment period will be necessary, but in instances of recurrence, the period of treatment may be prolonged further.

Contraindications
ERYACNE should not be used by patients who have shown hypersensitivity to erythromycin or any of the other ingredients. If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue temporarily or to discontinue use altogether.

Warnings and Precautions
Eryacne gel is for external use only.
ERYACNE should not come into contact with the eyes, lips, nose, open wounds and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Concomitant use of cosmetic products containing alcohol or abrasives or medicated soaps may cause a cumulative irritant or drying effect. The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, administration of this drug should be discontinued and appropriate measures taken.
Use in pregnancy: Category A
Use in lactation: It is not known whether erythromycin is excreted in human milk after topical application. However this is reported to occur with oral or parenteral administration. Therefore caution should be exercised when ERYACNE is administered to a nursing woman.

Adverse Effects
Adverse effect reported with erythromycin therapy, such as ERYACNE, include dryness, tenderness, pruritus, desquamation, erythema, oiliness and burning sensation. Irritation of the eye has also been reported. The skin irritation reported has ranged from mild to severe. A case of generalised urticaria reaction, possibly related to the drug, which required the use of systemic steroids has been reported.

Interactions
Because of the competitive binding for the 50S ribosomal subunits, erythromycin and clindamycin topical preparations should not be used concomitantly.
Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, especially with the use of peeling desquamating or abrasive agents.

Overdosage
If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.

Pharmaceutical Precautions
Store below 25°C.
Keep out of reach of children.

Medicine Classification
Prescription Medicine.

Package Quantities
ERYACNE is packaged in a 30g laminated aluminium tube coated with epoxy resin and equipped with a polyethylene dip-tube and a polyethylene cap.