Altargo - retapamulin

What is Altargo?

Altargo is an ointment containing the active substance retapamulin.

What is Altargo used for?

Altargo is an antibiotic used in the short-term treatment of superficial skin infections such as: impetigo (an infection of the skin that causes scab) and small lacerations, abrasions and infected sutured wounds. Altargo should not be used to treat infections that are or are thought to be probably due to methicillin-resistant Staphylococcus aureus (MRSA), as they may not act against this type of infection. However, it can be used to treat infections caused by other types of Staphylococcus aureus . The drug should be prescribed by paying attention to official guidelines on the appropriate use of antibacterial agents.

The medicine can only be obtained with a prescription.

How is Altargo used?

Altargo is indicated for skin use only. A thin layer of ointment is applied to the affected area twice a day for five days. The treated area can be covered with a sterile bandage or gauze. Altargo can be used starting from nine months of age; however in patients under the age of 18 the treated surface should not be greater than 2% of the total body surface. Patients who do not show a response within two or three days should be visited again and alternative therapy should be provided.

How does Altargo work?

The active substance in Altargo, retapamulin, is an antibiotic belonging to the "pleuromutilin" class. It is derived from a compound produced by certain types of fungus. The antibiotic blocks bacterial ribosomes (ie the parts of the cell in which proteins are produced) and thereby inhibits the growth of bacteria. In the Summary of Product Characteristics the complete list of bacteria against which Altargo is active is shown.

How has Altargo been studied?

The effects of Altargo were first tested in experimental models before being studied in humans. Altargo has been studied in five main studies involving over 3, 000 patients starting at nine months of age. Two studies were performed on patients with impetigo. In the first study the effects of five days of treatment with Altargo were compared to a placebo treatment (substance with no effect on the organism) in 213 patients, while in the second study Altargo was compared to fusidic acid (another antibiotic ointment ) in 519 patients. In the other three studies the effects of five days of treatment with Altargo were compared to those of cefalessin (an oral antibiotic): two studies were conducted on a total of 1 918 patients with skin wound infections and the last study was conducted on 545 patients with infected dermatitis (skin inflammation). In all five studies the main measure of effectiveness was the percentage of patients whose infection had healed at the end of treatment.

What benefit has Altargo shown during the studies?

In patients with impetigo, Altargo was more effective than placebo: out of 139 patients who used Altargo, 119 (85.6%) responded to treatment; in the 71 placebo-treated patients, 37 patients (52.1%) responded to treatment. Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 patients responding to treatment compared to 141 (94.0%) of 150 patients. In the treatment of skin wound infections, Altargo and cefalessina reported similar response rates: considering together the results of both studies on skin wounds, about 90% of both patient groups responded to treatment. From these two studies, however, it was found that Altargo was not sufficiently effective in treating abscesses (caries containing pus) or infections due or probably caused by MRSA.

The data presented was insufficient to support the use of Altargo in the treatment of infected dermatitis.

What is the risk associated with Altargo?

The most common side effect of Altargo (seen between 1 and 10 patients in 100) was irritation at the application site. For the full list of all side effects reported with Altargo, see the Package Leaflet.

Altargo should not be used in people who may be hypersensitive (allergic) to retapamulin or any of the other substances.

Why has Altargo been approved?

The Committee for Medicinal Products for Human Use (CHMP) has stated that Altargo's benefits are greater than its risks in the short-term treatment of the following superficial skin infections: