COMPOSITION :

Each 5 ml (reconstituted suspension) contains : Erythromycin Ethyl Succinate equivalent to Erythromycin 125 mg,

200 mg or 250 mg .

Each f/c tablet contains : Erythromycin Stearate equivalent to Erythromycin 250 mg or 500 mg .

DESCRIPTION :

Erythrosan (Erythromycin) is a macrolide antibiotic with a primarily bacteriostatic action against a broad range of

bacteria including Gram - positive bacteria such as Streptococcus pneumoniae, Streptococcus pyogenes and most

strains of Staphylococcus aureus, Bacillus anthracis, Corynebacterium diphtheriae and Clostridium spp., Gram -

negative bacteria such as Neisseria, Moraxella, H. influenzae, Actinomyces, Chlamydia, Rickettsias, Treponema

pallidum .Erythromycin is adequately absorbed after oral administration. Peak plasma concentrations occur between

1 and 4 hours. Erythromycin is widely distributed throughout body tissues and fluids with a high concentration in the

liver and spleen. It is mainly excreted in the bile. Erythromycin crosses the placenta and is excreted in breast milk.

INDICATIONS :

Erythrosan is indicated in the treatment of infections caused by susceptible microorganisms as :

- Eye infections : blepharitis.

- Ear infections : otitis media, otitis externa, mastoiditis.

- Oral infections : gingivitis, Vincent’s angina, dental infections.

- Respiratory tract infections : tonsillitis , pharyngitis, laryngitis, sinusitis, secondary infections in colds and influenza ,

tracheitis , acute and chronic bronchitis, pneumonia (including Mycoplasma pneumonia).

- Gastro-intestinal tract infections : cholecystitis, staphylococcus enterocolitis, intestinal amebiasis (Entamoeba

histolytica).

- Skin and soft tissue infections : boils , abscesses, pustular acne , impetigo.

- Prophylaxis : pre and post-operative , trauma , burns , rheumatic fever.

- Other infections : diphtheria, scarlet fever, urethritis, gonorrhea, syphilis and lymphogranuloma venerum.

DOSAGE AND ADMINISTRATION :

Children up to 2 years : 125 mg every 6 hours.

Children 2 - 8 years : 200 - 250 mg every 6 hours and may be doubled for severe infections.

Adults and children over 8 years : 250 - 500 mg every 6 hours or 0.5 - 1 g every 12 hours and up to 4 g daily in

severe infections.

Early syphilis : 500 mg 4 times daily for 14 - 21 days.

Non-gonococcal urethritis : 500 mg 2 - 4 times daily for 7 - 14 days.

RESTRICTIONS ON USE :

Contraindications

- Erythromycin is contraindicated in patients with known hypersensitivity to the drug.

- Erythromycin is contraindicated in patients taking terfenadine.

Precautions

- As with other Erythromycins caution should be exercised in patients with existing liver diseases or impaired hepatic

function.

- Use with care in patients with a history of arrhythmias.

Use in pregnancy and lactation

Use erythromycin in pregnant women only if clearly needed and exercise caution when administer to nursing women.

DRUG INTERACTIONS :

Concomitant administration of Erythromycin with the following drugs may increase the potentiality or the toxicity of

these drugs because of its effect on the cytochrome P - 450 : Alfentanil, Astemizole, Bromocriptine, Theophylline,

Digoxin, Warfarin, Ergotamine, Triazolam, and Terfenadine.

ADVERSE EFFECTS :

The most frequent side effects are nausea, vomiting, abdominal discomfort, diarrhea, urticaria, rashes, and allergic

reactions.

STORAGE INSTRUCTIONS :

Dry powder : Store below 30oC in a dry place.

Reconstituted suspension : Store in a refrigerator and use within 10 days.

Tablet : Store below 30oC in a dry place.

PRESENTATIONS :

Erythrosan Powder for oral suspension 125, 200 or 250 mg : Bottle of 100 ml (after reconstitution).

Erythrosan f/c Tablets : Pack of 20 tablets and hospital packs of different sizes.