Altargo 1% ointment

 

What is it and how is it used?

Altargo is used to treat bacterial infections affecting small areas of skin. Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.

Altargo is for adults and children aged nine months and older.

What do you have to consider before using it?

Do not use Altargo:

If you are allergic (hypersensitive) to retapamulin or any of the other ingredients of Altargo.

Take special care with Altargo:

If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor. See also section 4 of this leaflet.

If there is no improvement in your infection after two to three days of treatment contact your doctor.

Using other medicines:

Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.

Tell your doctor or healthcare provider:

If the patient is a child less than two years old it is important that you tell your doctor about any other medicines that the child is being given, including medicines bought without a prescription. It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual. This might lead to side effects. Your doctor will decide if Altargo can be used for a child aged less than 2 years old who is taking other medicines.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before using any medicine.

Do not use Altargo if you are pregnant, or planning to become pregnant. Ask your doctor or pharmacist for advice.
Do not use Altargo if you are breast-feeding a baby. Ask your doctor or pharmacist for advice.

How is it used?

Always use Altargo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Altargo is for use on the skin only. It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area. If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort. If you accidentally use Altargo inside your nose you could have a nose bleed.

Wash your hands before and after applying the ointment.

How to apply Altargo
A thin layer of ointment is usually put on the infected skin twice a day for five days. After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
Keep using Altargo for as long as your doctor advises.

If you use too much Altargo

Carefully wipe off the extra ointment.

Problems with overdosage with this medicine are unlikely.

If you forget to use Altargo

Apply the ointment as soon as you remember, and apply the next dose at the usual time.

If you accidentally swallow Altargo

Contact your doctor or pharmacist for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Altargo can cause side effects, although not everybody gets them.

These side effects have occurred on the skin where Altargo has been applied:

Common side effects

  • skin irritation

This may affect up to 1 in 10 people.

Uncommon side effects

  • pain, itching, redness or rash (contact dermatitis)

These may affect up to 1 in 100 people.

Other side effects

  • a burning sensation
  • an allergic reaction

It is not known how many people this may affect.

Altargo contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

If you develop signs of a local reaction, such as itching, swelling, redness or pain where you have used Altargo: Tell your doctor.

If you have a severe reaction (e.g. severe itching or severe rash, swelling of the face, lips, or tongue): Stop using Altargo, carefully wipe off the ointment, and contact your doctor or pharmacist immediately.

If any of the side effects gets serious, or if you notice any side-effects that are not mentioned in this leaflet: Tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Altargo after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.

Discard open tubes 7 days after opening.
Return any unused Altargo to your pharmacist.

What is it?

Altargo is an ointment that contains the active substance retapamulin.

What is it used for?

Altargo is an antibiotic medicine. It is used for short-term treatment of superficial skin infections. It can be used to treat impetigo (a skin infection causing crusting scabs), and small infected lacerations (cuts), abrasions (grazes) and wounds that have been sutured (stitched). Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection. However, it may be used to treat infections caused by other types of Staphylococcus aureus. Prescribers should consider official guidance on the use of antibacterial agents.
The medicine can only be obtained with a prescription.

How is it used?

Altargo should only be used on the skin. It is applied onto the affected area as a thin layer twice a day for five days. The treated area can be covered with a sterile bandage or gauze dressing. Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body’s surface. If there is no response to treatment after two to three days, doctors should re-evaluate the patient and consider alternative treatments.

How does it 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. It works by blocking the bacteria’s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria. The full list of bacteria against which Altargo is active can be found in the Summary of Product Characteristics.

How has it 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 aged from 9 months upwards. Two studies were carried out in patients with impetigo. The first compared the effects of five days’ treatment with Altargo to those of placebo (a dummy treatment) in 213 patients, and the second compared Altargo to fusidic acid (another antibiotic ointment) in 519 patients. The other three studies compared the effects of five days’ treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation). In all five studies, the main measure of effectiveness was the proportion of patients whose infections had cleared up after the end of treatment.

What benefits has it shown during the studies?

In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment. Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment. For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment. However, these two studies found that Altargo was not sufficiently effective in the treatment of abscesses (cavities containing pus) or of infections known or likely to be caused by MRSA.
The data presented were insufficient to support the use of Altargo in the treatment of infected dermatitis.

What is the risk associated?

The most common side effect with Altargo (seen in between 1 and 10 patients in 100) is irritation at the site of application. 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 ingredients.

Why has it been approved?

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

  • impetigo,
  • infected small lacerations, abrasions or sutured wounds. The Committee recommended that Altargo be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Altargoto Glaxo Group Ltd on 24 May 2007 .