ERYBOSTON

Dosage

Adults/Elderly/Children over 8 years

250-500 mg every 6 hours, up to 4 g daily for more severe infections.

For pustular acne the usual dose is 250 mg three times daily before meals for one to four weeks and then reduced to twice daily until improvement occurs.

Children aged 2 to 8 years

30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Normal dose: 250 mg four times a day.

Infants and babies up to 2 years

30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Normal dose: 125 mg fours time a day or 250 mg twice daily.

Renal Impairment

If impairment is severe (GFR < 10 ml/min), the daily dose should not exceed 1.5 g due to risk of ototoxicity.

ADMINISTRATION

Oral administration. It is dispersed with water before use.

CONTRAINDICATIONS

Hypersensitivity to erythromycin or any excipients.

Patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, cisapride or pimozide, ergotamine and dihydroergotamine.

WARNINGS AND PRECAUTIONS

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. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents including erythromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with statins.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None stated.

UNDESIRABLE EFFECTS

Blood and lymphatic system disorders:

Eosinophilia.

Cardiac disorders:

QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.

Ear and labyrinth disorders:

Deafness, tinnitus.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency or high doses.

Gastrointestinal disorders:

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. The following have been reported: upper abdominal discomfort, nausea, vomiting, diarrhea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis. Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.

General disorders and administration site conditions:

Chest pain, fever, malaise.

Hepatobiliary disorders:

Cholestatic hepatitis, jaundice, hepatic disfunction, hepatomegaly, hepatic failure, hepatocellular hepatitis.

Immune system disorders:

Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.

Investigations:

Increased liver enzyme values.

Nervous system disorders:

There have been isolated reports of transient central nervous system side effects including confusion, seizures and vertigo; however, a cause and effect relationship has not been established.

Psychiatric disorders:

Hallucinations.

Renal and urinary disorders:

Interstitial nephritis.

Skin and subcutaneous tissue disorders:

Skin eruptions, pruritus, urticaria, exanthema, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Vascular disorders:

Hypotension.

OVERDOSE AND TREATMENT

Symptoms of erythromycin overdosage include hearing loss, severe nausea, vomiting and diarrhea. Treatment consists of gastric lavage and symptomatic and supportive therapy as needed. Erythromycin is not dialyzable. 

STORAGE CONDITION

In a dry place, below 30°C, protect from light.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date.