Indications

1. Upper Respiratory Tract infections; Lower Respiratory Tract infections; Ear infection; Oral infections; Eye infections; Skin and soft tissue infections; Gastrointestinal infections; Prophylaxis

2. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever

Dosage and Administration

Usage:Oral

1. Adults and children over 8 years: For mild to moderate infections 1-2g daily in divided doses. Up to 4g daily in severe infections.

2. Elderly: No special dosage recommendations.

3. Paediatric population: For younger children, infants and babies, erythromycin suspensions is normally recommended. The recommended dose for children age 2-8 years, for mild to moderate infections, is 1 gram daily in divided doses. The recommended dose for infants and babies, for mild to moderate infections, is 500 mg daily in divided doses. For severe infections doses may be doubled.

Precautions & Warning:

1.Erythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents.

2.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening.

3.As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported.

4.Cardiovascular Events.

Contraindications:

1. Hypersensitivity to the active substance or to any of the excipients

2. Erythromycin is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or pimozide.

3. Erythromycin should not be given to patients with a history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes.

4. Erythromycin should not be given to patients with electrolyte disturbances (hypokalaemia, hypomagnesaemia due to the risk of prolongation of QT interval).

5. Erythromycin is contraindicated with ergotamine and dihydroergotamine.

6. Concomitant administration of erythromycin and lomitapide is contraindicated.

Adverse Reactions:

1. Infections and infestations: Pseudomembranous colitis. Has been rarely reported in association with erythromycin therapy

2. Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Drug interactions:

Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 system may occur : when administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, carbamazepine, cilostazol, cyclosporin, digoxin, dihydroergotamine, disopyramide, ergotamine, hexobarbitone, methylprednisolone, midazolam, omeprazole, phenytoin, quinidine, rifabutin, sildenafil, tacrolimus, terfenadine, domperidone, theophylline, triazolam, valproate, vinblastine, and antifungals e.g fluconazole, ketoconazole and itraconazole. Appropriate monitoring should be undertaken and dosage should be adjusted as necessary. Particular care should be taken with medications known to prolong the QTc interval of the electrocardiogram.

Storage instructions:

Keep in a cool, dry place and away from children.