ALTARGO Ointment Ref.[8736] Active ingredients: Retapamulin

Posology

Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine months to 11 years)

A thin layer of ointment should be applied to the affected area twice daily for five days.

The area treated may be covered with sterile bandage or gauze dressing.

Safety and efficacy have not been established in the following:

• Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
• Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.

In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.

Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).

Special populations

Elderly (aged 65 and older): No dosage adjustment is necessary.

Renal impairment: No dosage adjustment is necessary. See section 5.3.

Hepatic impairment: No dosage adjustment is necessary. See section 5.3.

Paediatric population: The safety and efficacy of retapamulin ointment in infants less than nine months of age has not been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.

Method of administration

Retapamulin is for cutaneous use only.

Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically.

No specific antidote is known.

Unopened tube and sachet: 2 years.

In-use tube: 7 days.

Do not store above 25°C.

0.5 g aluminium foil sachet. Carton of 12 sachets.

5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.

Not all pack sizes may be marketed.

Any remaining ointment at the end of treatment should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.