What is Altabax, and how does it work?
Altabax is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillinsusceptible isolates only) or Streptococcus pyogenes. Safety in patients younger than 9 months has not been established.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Altabax and other antibacterial drugs, Altabax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
What are the side effects of Altabax?
Clinical Studies Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from the clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The safety profile of Altabax was assessed in 2,115 adult and pediatric subjects 9 months and older who used at least one dose from a 5-day, twice-a-day regimen of retapamulin ointment. Control groups included 819 adult and pediatric subjects who used at least one dose of the active control (oral cephalexin), 172 subjects who used an active topical comparator (not available in the US), and 71 subjects who used placebo.
Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of subjects treated with retapamulin ointment, 6.6% (54/819) of subjects receiving cephalexin, and 2.8% (2/71) of subjects receiving placebo.
The most common drug-related adverse events (greater than or equal to 1% of subjects) were
- application site irritation (1.4%) in the retapamulin group,
- diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and
- application site paresthesia (1.4%) in the placebo group.
Adults
The adverse events, regardless of attribution, reported in at least 1% of adults (aged 18 years and older) who received Altabax or comparator are presented in Table 1.
Table 1. Adverse Events Reported by ≥1% of Adult Subjects Treated with Altabax or Comparator in Phase 3 Clinical Trials
Adverse Event | Altabax N = 1,527 % | Cephalexin N = 698 % |
Headache | 2.0 | 2.0 |
Application site irritation | 1.6 | <1.0 |
Diarrhea | 1.4 | 2.3 |
Nausea | 1.2 | 1.9 |
Nasopharyngitis | 1.2 | <1.0 |
Creatinine phosphokinase increased | <1.0 | 1.0 |
Pediatrics
The adverse events, regardless of attribution, reported in at least 1% of pediatric subjects aged 9 months to 17 years who received Altabax are presented in Table 2.
Table 2. Adverse Events Reported by ≥1% in Pediatric Subjects Aged 9 Months to 17 Years Treated with Altabax in Phase 3 Clinical Trials
Adverse Event | Altabax N = 588 % | Cephalexin N = 121 % | Placebo N = 64 % |
Application site pruritus | 1.9 | 0 | 0 |
Diarrhea | 1.7 | 5.0 | 0 |
Nasopharyngitis | 1.5 | 1.7 | 0 |
Pruritus | 1.5 | 1.0 | 1.6 |
Eczema | 1.0 | 0 | 0 |
Headache | 1.2 | 1.7 | 0 |
Pyrexia | 1.2 | <1.0 | 1.6 |
Other Adverse Events
Application site pain, erythema, and contact dermatitis were reported in less than 1% of subjects in clinical trials.
Postmarketing Experience
In addition to reports in clinical trials, the following events have been identified during postmarketing use of Altabax. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders And Administration Site Conditions
Application site burning.
Immune System Disorders
Hypersensitivity including angioedema.
What is the dosage for Altabax?
A thin layer of Altabax should be applied to the affected area (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired.
What drugs interact with Altabax?
- Coadministration of oral ketoconazole 200 mg twice daily increased retapamulin geometric mean AUC(0-24) and Cmax by 81% after topical application of retapamulin ointment, 1% on the abraded skin of healthy adult males.
- Due to low systemic exposure to retapamulin following topical application in adults and pediatric patients aged 2 years and older, dosage adjustments for retapamulin are unnecessary in these patients when coadministered with CYP3A4 inhibitors, such as ketoconazole.
- Based on in vitro P450 inhibition studies and the low systemic exposure observed following topical application of Altabax, retapamulin is unlikely to affect the metabolism of other P450 substrates.
- Concomitant administration of retapamulin and CYP3A4 inhibitors, such as ketoconazole, has not been studied in pediatric patients.
- In pediatric subjects aged 2 to 24 months, systemic exposure of retapamulin was higher compared with subjects aged 2 years and older after topical application.
- Based on the higher exposure of retapamulin, it is not recommended to coadminister Altabax with strong CYP3A4 inhibitors in patients younger than 24 months.
- The effect of concurrent application of Altabax and other topical products to the same area of skin has not been studied.
Is Altabax safe to use while pregnant or breastfeeding?
- There are no available data on Altabax use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.
- There are no data available on the presence of retapamulin in human milk, its effects on the breastfed infant or its effects on milk production.
- However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of retapamulin in humans following topical administration of Altabax.

SLIDESHOW
8 First Aid Kit Essentials for Scrapes, Cuts, Bug Bites, and More See SlideshowSummary
Altabax is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillinsusceptible isolates only) or Streptococcus pyogenes. Safety in patients younger than 9 months has not been established.
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Staph (Staphylococcus) Infection
Staphylococcus or staph is a group of bacteria that can cause a multitude of diseases. Staph infections can cause illness directly by infection or indirectly by the toxins they produce. Symptoms and signs of a staph infection include redness, swelling, pain, and drainage of pus. Minor skin infections are treated with an antibiotic ointment, while more serious infections are treated with intravenous antibiotics.
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Impetigo
Impetigo is a contagious skin infection caused by staph and strep bacteria. There are two types of impetigo: nonbullous and bullous. Symptoms of nonbullous impetigo include small blisters on the nose, face, arms, or legs and possibly swollen glands. Bullous impetigo signs include blisters in various areas, particularly in the buttocks area. Treatment involves gentle cleansing, removing the crusts of popped blisters, and the application of prescription-strength mupirocin antibiotic ointment.
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Is a Staph Infection Contagious?
A staph infection is caused by the bacteria Staphylococcus aureus. Staph can cause boils, food poisoning, cellulitis, toxic shock syndrome, MRSA, and various other illnesses and infections. Most staph infections are transmitted from person to person.
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Streptococcal Infections
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Streptococcal Infections
Group A streptococcal infections are caused by group A Streptococcus, a bacteria that causes a variety of health problems, including strep throat, impetigo, cellulitis, erysipelas, and scarlet fever. There are more than 10 million group A strep infections each year.
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What Is the Best Treatment for Impetigo?
Impetigo is a bacterial skin infection that causes a rash that forms blisters and can ooze pus, causing a crust. Impetigo can be caused by different kinds of bacteria, including strep and staph. Usually, impetigo is easy to treat and rarely leaves scarring.
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Is Impetigo Contagious?
Impetigo is a contagious bacterial infection that usually occurs in children ages 2-5. There are two types of impetigo: bullous and nonbullous. With nonbullous impetigo, pus-filled blisters develop, ooze, and crust over on the patient's torso, in contrast with bullous impetigo, which is typically confined to the extremities and the face near the mouth.
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How Serious Is a Staph Infection?
A Staphylococcus or staph infection is caused by a germ that may be found in 30% of healthy people’s noses. Most of the time, these bacteria do not cause any health problems. However, in some people, it may cause skin and other organ infections. Most often, staph causes minor skin infections such as a boil. However, if it enters into your bloodstream and other organs, it may turn out to be deadly.
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Sinus Infection vs. Cold
Viruses cause the common cold and most sinus infections. Bacterial and fungal infections may also cause a sinus infection. Signs and symptoms of colds and sinus infections include nasal irritation or dryness, sore throat, stuffy nose, nasal discharge/congestion, sneezing, and cough. Additional symptoms of sinus infections include sinus pressure behind the cheeks or eyes, facial pain when pressure is applied, bad breath, and thick yellow or green mucus. Treatment focuses on symptom relief.
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Staph Infection Causes
Staph or Staphylococcus is a group of bacteria that is found over the skin of most individuals. Staph bacteria usually live inside the nose, but they do not cause an infection. Staph infections may turn deadly if the bacteria invade deeper into the body, entering the bloodstream, joints, bones, lungs, or heart.
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Impetigo Symptoms and Treatments
Impetigo is a mild infection and can affect any part of the body. Mostly, it affects the nose and mouth or arms or legs. Impetigo causes red, itchy sores, pus discharge and scabs that form over the sores.
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