Each gram of Erythromycin 1% ointment contains:

active ingredient: erythromycin – 10 mg;

excipients: liquid paraffin, propylparaben white soft paraffin (vaseline), ethanol 96%.

Erythromycin 1% ointment contains the active ingredient erythromycin, which is a type of medicine known as a macrolide antibiotic.

Erythromycin is a macrolide antibiotic. It interferes with bacterial protein synthesis by binding to the 50S subunit of ribosomes of sensitive organisms.

Erythromycin 1% ointment is applied to the skin to treat acne. The erythromycin works by attacking the bacteria associated with acne, Propionibacterium acnes. This is a common type of bacteria that feeds on sebum produced by the sebaceous glands in the skin. Although the mechanism of action of Erythromycin in reducing inflammatory lesions of acne vulgaris has not been conclusively shown, it is presumably due to its antibiotic action on sensitive bacteria, and in reducing follicular porphyrin fluorescence and free fatty acid levels of skin lipids.

Erythromycin prevens these bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers. Erythromycin doesn’t directly kill the bacteria, but leaves them unable to increase in numbers. The remaining bacteria eventually die or are destroyed by the immune system.

By controlling bacterial numbers, erythromycin brings the inflammation of the sebaceous glands under control, and allows the skin to heal.

• 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.
• Bacterial skin infections (treatment and prophylaxis): erythromycin ointment is used in the topical prophylaxis and treatment of superficial pyogenic infections of the skin.

Administration

Topical, to the skin, two times a day, morning and evening.

This medicine is for external use only.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. In the event of irritation, stop using Erythromycin and consult your doctor.

Avoid getting this medicine in contact with your eyes, mouth or the inside of your nose. If accidental contact does occur, the area should be washed with lukewarm water.

The Propionibacterium is becoming more resistant to antibiotics. To help avoid the development of resistance, your doctor should avoid prescribing different antibiotics for you to take by mouth while you are using this antibiotic on your skin. You should not use this medicine for longer than necessary, however, treatment should usually be continued for at least six months.

Paediatric use

• Safety and effectiveness of Erythromycin 1% ointment for topical use in children have not been established.

In cases of accidental oral ingestion, treatment is symptomatic and supportive.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, specially with the use of abrasive agents. The use of topical antimicrobial agents has been associated with the overgrowth of antibiotic-resistant organisms on the skin. Should this occur, administration should be discontinued and appropriate measures taken.

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

There are no known harmful effects when this medicine is used by pregnant or breastfeeding mothers. However, if used by breastfeeding mothers it should not be applied to the chest to avoid the child accidentally ingesting it while feeding.

Your skin may be more likely to get dry or irritated if you are use other topical preparations on your skin, for example medicated cosmetics, soaps, toiletries or other anti-acne preparations, in combination with this medicine.

When taken by mouth erythromycin can interact with many other medicines. However, when applied to the skin, erythromycin is not expected to be absorbed in sufficient quantities to cause problems with other medicines.

A white, homogenous ointment, odorless.

20g and 25 g of ointment is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

3 years. Do not use after the expiration date.

To be dispensed with prescription.

Store at a room temperature (15-25⁰C), in a dry place, out of the reach of children. Protect from light.