When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Update sections 2, 4.1, 4.4, 4.5, 5.1, 6.4 and 10 as noted below in bold following renewal of licence.
2. Qualitative and Quantitative Composition Erythromycin (as erythromycin ethylsuccinate) 125 mg per 5 ml Excipients - Contains sorbitol (E420) 1182mg/5ml, Sodium methylhydroxybenzoate (E219) 5mg/5ml and sodium propylhydroxybenzoate (E217) 1mg/5ml. This medicinal product contains 4.21 mg of sodium per ml of suspension (equates to 21.05mg/5ml dose). For a full list of excipients, see section 6.1 4.1 Therapeutic Indications Erythromycin is indicated for the treatment of infections caused by erythromycin sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.4 Special warnings and precautions for use 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 hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin. The use of erythromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system may be associated with elevations in serum levels of these drugs (see sections 4.5). Serum concentrations should be closely monitored in patients receiving erythromycin. Prolonged or repeated use of erythromycin may result in overgrowth of non-susceptible bacteria. If super-infection occurs, erythromycin should be discontinued and appropriate therapy instituted. 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 carefully considered against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability occur. 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. As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin (see section 4.8). Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin (see section 4.5). There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis. Colchicine toxicity has been reported in patients receiving erythromycin concomitantly with colchicines (see section 4.5). Laboratory Tests: Erythromycin interferes with the fluorometric determination of urinary catecholamines. Contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed). This medicinal product contains 4.21 mg of sodium per ml of suspension (equates to 21.05 mg/5ml dose). This needs to be taken into consideration when prescribing for patients on a sodium-restricted diet. 4.5 Interactions with other medicinal products and other forms of interaction 5.1 Pharmacodynamic properties ATC Code: J01FA Pharmacotherapeutic group: Macrolides Erythromycin ethylsuccinate is less susceptible than erythromycin to the adverse effect of gastric acid. It is absorbed from the small intestine. It is widely distributed throughout body tissues. Little metabolism occurs and only about 5% is excreted in the urine. It is excreted principally by the liver. 6.4 Special Precautions for Storage Do not store above 25°C. Keep the bottle tightly closed. 10. Date of (Partial) Revision of the Text September 2010
Erythromycin (as erythromycin ethylsuccinate) 125 mg per 5 ml
Excipients - Contains sorbitol (E420) 1182mg/5ml, Sodium methylhydroxybenzoate (E219) 5mg/5ml and sodium propylhydroxybenzoate (E217) 1mg/5ml. This medicinal product contains 4.21 mg of sodium per ml of suspension (equates to 21.05mg/5ml dose).
For a full list of excipients, see section 6.1
4.1 Therapeutic Indications
Erythromycin is indicated for the treatment of infections caused by erythromycin sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.4 Special warnings and precautions for use
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 hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.
The use of erythromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system may be associated with elevations in serum levels of these drugs (see sections 4.5). Serum concentrations should be closely monitored in patients receiving erythromycin.
Prolonged or repeated use of erythromycin may result in overgrowth of non-susceptible bacteria. If super-infection occurs, erythromycin should be discontinued and appropriate therapy instituted.
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 carefully considered against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability occur.
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.
As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin (see section 4.8).
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin (see section 4.5).
There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.
Colchicine toxicity has been reported in patients receiving erythromycin concomitantly with colchicines (see section 4.5).
Laboratory Tests:
Erythromycin interferes with the fluorometric determination of urinary catecholamines.
Contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
This medicinal product contains 4.21 mg of sodium per ml of suspension (equates to 21.05 mg/5ml dose). This needs to be taken into consideration when prescribing for patients on a sodium-restricted diet.
4.5 Interactions with other medicinal products and other forms of interaction
5.1 Pharmacodynamic properties
ATC Code: J01FA
Pharmacotherapeutic group: Macrolides
Erythromycin ethylsuccinate is less susceptible than erythromycin to the adverse effect of gastric acid. It is absorbed from the small intestine. It is widely distributed throughout body tissues. Little metabolism occurs and only about 5% is excreted in the urine. It is excreted principally by the liver.
6.4 Special Precautions for Storage
Do not store above 25°C. Keep the bottle tightly closed.
September 2010