ERYTHROMYCIN Granules for oral suspension Ref.[6824] Active ingredients: Erythromycin

Method of Administration

For oral administration only.

Posology

Adults, including elderly, and children over 8 years

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

For acne vulgaris 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 2 to 8 years

250 mg every six hours, doubled for severe infections.

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

Children up to 2 years

125 mg every six hours, doubled for severe infections.

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

Renal Impairment

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

Symptoms: hearing loss, severe nausea, vomiting and diarrhoea.

Treatment: gastric lavage, general supportive measures.

Erythromycin is not dialysable.

Shelf life

Unopened: 3 years.

Once reconstituted: 14 days.

Granules: do not store above 25°C.

Following reconstitution: store at 2°C-8°C (in a refrigerator). Do not freeze. When storing keep the cap tightly closed. The reconstituted granules have a shelf life of 14 days. Shake well before administration. Keep out of the reach and sight of children

Amber (Type III) glass bottles with tamper evident polypropylene cap (100 ml, 140 ml, and 150ml).

White HDPE plastic bottles with wadded, tamper evident polypropylene cap (100 ml, 125 ml 140 ml and 150 ml)

Pack sizes 60 ml, 100 ml.

Not all pack sizes may be marketed.

60 ml suspension: to reconstitute add 36 ml water and shake the bottle vigorously. The resulting suspension is yellow in colour.

100 ml suspension: to reconstitute add 60ml water and shake the bottle vigorously. The resulting suspension is yellow in colour.