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Drug overview for ALTABAX (retapamulin):
Generic name: RETAPAMULIN (RE-te-PAM-ue-lin)
Drug class: Topical Antibiotics
Therapeutic class: Dermatological
Retapamulin is a pleuromutilin anti-infective.
No enhanced Uses information available for this drug.
Generic name: RETAPAMULIN (RE-te-PAM-ue-lin)
Drug class: Topical Antibiotics
Therapeutic class: Dermatological
Retapamulin is a pleuromutilin anti-infective.
No enhanced Uses information available for this drug.
DRUG IMAGES
ALTABAX 1% OINTMENT
The following indications for ALTABAX (retapamulin) have been approved by the FDA:
Indications:
Impetigo
Professional Synonyms:
Impetigo contagiosa
Impetigo vulgaris
Indications:
Impetigo
Professional Synonyms:
Impetigo contagiosa
Impetigo vulgaris
The following dosing information is available for ALTABAX (retapamulin):
For the topical treatment of impetigo in pediatric patients 9 months of age or older, retapamulin 1% ointment should be applied to the affected area twice daily for 5 days. The treatment area in this age group should not exceed 2% of total body surface area.
For the topical treatment of impetigo in adults, retapamulin 1% ointment should be applied to the affected area twice daily for 5 days. The treatment area should not exceed 100 cm2.
For the topical treatment of impetigo in adults, retapamulin 1% ointment should be applied to the affected area twice daily for 5 days. The treatment area should not exceed 100 cm2.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALTABAX 1% OINTMENT | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for ALTABAX (retapamulin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALTABAX (retapamulin):
Drug contraindication overview.
The manufacturer states that there are no known contraindications for the use of topical retapamulin.
The manufacturer states that there are no known contraindications for the use of topical retapamulin.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ALTABAX (retapamulin):
Adverse reaction overview.
The most frequent adverse reaction to topical retapamulin is application site irritation.
The most frequent adverse reaction to topical retapamulin is application site irritation.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Angioedema |
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Skin irritation |
Paresthesia Pruritus of skin |
| Rare/Very Rare |
|---|
|
Acute pain at drug application site Contact dermatitis Erythema Stinging of skin |
The following precautions are available for ALTABAX (retapamulin):
Safety and efficacy of topical retapamulin have not been established in infants younger than 9 months of age. Safety and efficacy of retapamulin 1% ointment for the topical treatment of impetigo in pediatric patients 9 months of age or older is supported by evidence from adequate and well-controlled studies that included 588 pediatric patients 9 months to 17 years of age. The safety profile and efficacy of topical retapamulin in pediatric patients in this age group is similar to that reported in adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies evaluating topical retapamulin in pregnant women. In rats, oral retapamulin at dosages of 150 mg/kg daily or greater was associated with maternal toxicity (decreased body weight gain, decreased food consumption) and developmental toxicity (decreased fetal body weight, delayed skeletal ossification); there were no treatment-related malformations in fetal rats. In rabbits, continuous IV infusion of retapamulin at dosages of 7.2
mg/kg daily or greater (eightfold greater than estimated maximum achievable human exposure based on area under the plasma concentration-time curve (AUC)) was associated with maternal toxicity (decreased body weight gain, decreased food consumption, abortions); there were no treatment-related effects on embryofetal development. Topical retapamulin should be used during pregnancy only when potential benefits outweigh potential risks.
mg/kg daily or greater (eightfold greater than estimated maximum achievable human exposure based on area under the plasma concentration-time curve (AUC)) was associated with maternal toxicity (decreased body weight gain, decreased food consumption, abortions); there were no treatment-related effects on embryofetal development. Topical retapamulin should be used during pregnancy only when potential benefits outweigh potential risks.
It is not known whether retapamulin is distributed into milk following topical application to skin. Topical retapamulin should be used with caution in nursing women.
Safety and efficacy of retapamulin 1% ointment in geriatric patients 65 years of age or older are similar to that reported in younger adults.
The following prioritized warning is available for ALTABAX (retapamulin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALTABAX (retapamulin)'s list of indications:
| Impetigo | |
| L01 | Impetigo |
| L01.0 | Impetigo |
| L01.00 | Impetigo, unspecified |
| L01.03 | Bullous impetigo |
| L01.09 | Other impetigo |
| L01.1 | Impetiginization of other dermatoses |
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