Altabax

Patients using ALTABAX and/or their guardians should receive the following information and instructions:

• Use ALTABAX as directed by the healthcare practitioner. As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
• ALTABAX is for external use only. Do not swallow ALTABAX or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
• The treated area may be covered by a sterile bandage or gauze dressing, if desired. This may also be helpful for infants and young children who accidentally touch or lick the lesion site. A bandage will protect the treated area and avoid accidental transfer of ointment to the eyes or other areas.
• Use the medication for the full time recommended by the healthcare practitioner, even though symptoms may have improved.
• Notify the healthcare practitioner if there is no improvement in symptoms within 3 to 4 days after starting use of ALTABAX.
• ALTABAX may cause reactions at the site of application of the ointment. Inform the healthcare practitioner if the area of application worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.

Do not use retapamulin topical to treat any skin condition that has not been checked by your doctor. Do not share this medication with another person, even if they have the same symptoms you have.

Impetigo is highly contagious and spreads easily from person to person. Each member of the household should be seen by a doctor if they start to show symptoms of impetigo.

Stop using retapamulin and call your doctor at once if you have severe burning, itching, redness, swelling, blistering, oozing, or other skin irritation where the medicine was applied.

You should not use retapamulin topical if you are allergic to it.

FDA pregnancy category B. Retapamulin topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether retapamulin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child younger than 9 months old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibacterial; pleuromutilin antibiotic.1 2 3 4 5 6 7

Contraindications

Manufacturer states no known contraindications.1

Warnings/Precautions

Warnings

For external use only.1 Use only for topical application to skin; not evaluated for topical use on mucosal surfaces.1 Not intended for oral, intranasal, ophthalmic, or intravaginal use.1

Sensitivity Reactions

Local irritation (i.e., application site irritation/pruritus, application site pain, eczema, erythema, contact dermatitis, pruritus) reported following topical application.1

If sensitization or severe local irritation occurs, discontinue the drug, wipe off ointment, and institute appropriate alternative therapy for the infection.1

General Precautions

Possible emergence and overgrowth of nonsusceptible bacteria.1

If superinfection occurs, discontinue the drug and institute appropriate therapy.1

To reduce development of drug-resistant bacteria and maintain effectiveness of retapamulin and other anti-infectives, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.1

Specific Populations

Category B.1

Not known whether topical retapamulin is distributed into milk.1 Caution advised.1

Safety and efficacy not established in children <9 months of age.1

Safety and efficacy in geriatric patients ≥65 years of age similar to younger adults.1

Common Adverse Effects

Application site irritation.1 7 9

Metabolized by CYP3A4.1

Possible effects of concurrent topical application of retapamulin and other topical products to the same skin area not studied to date.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Because retapamulin has low systemic exposure following topical application to skin, retapamulin dosage adjustments are unnecessary when administered concomitantly with CYP3A4 inhibitors (e.g., ketoconazole).1

Based on in vitro CYP inhibition studies and low systemic exposure following topical application to skin, retapamulin is unlikely to affect metabolism of other CYP substrates.1

Specific Drugs

• Importance of applying to affected skin as directed and avoiding use in the eyes and nose, on the mouth or lips, or inside the female genital tract; do not swallow.1

• Importance of completing full course of treatment, even if symptoms improve.1

• Importance of notifying clinician if symptoms do not improve within 3–4 days after starting therapy.1

• Importance of discontinuing use and contacting clinician if application site worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.1

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

If your skin infection does not improve within 3 to 4 days, or if it becomes worse, check with your doctor .

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Local Irritation

In the event of sensitization or severe local irritation from Altabax, usage should be discontinued, the ointment wiped off, and appropriate alternative therapy for the infection instituted [see Patient Counseling Information (17)].

Not for Systemic or Mucosal Use

Altabax is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. The efficacy and safety of Altabax on mucosal surfaces have not been established. Epistaxis has been reported with the use of Altabax on nasal mucosa.

Potential for Microbial Overgrowth

The use of antibiotics may promote the selection of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.

Prescribing Altabax in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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 [see Pharmacokinetics (12.3)]. 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.

Do not use Altabax to treat any skin condition that has not been checked by your doctor. Do not share Altabax with another person, even if they have the same symptoms you have. Impetigo is highly contagious and spreads easily from person to person. Each member of the household should be seen by a doctor if they start to show symptoms of impetigo. Stop using Altabax and call your doctor at once if you have severe burning, itching, redness, swelling, blistering, oozing, or other skin irritation where the medicine was applied.

You should not use Altabax if you are allergic to retapamulin.

FDA pregnancy category B. Altabax is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether retapamulin passes into breast milk or if it could harm a nursing baby. Do not use Altabax without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child younger than 9 months old.

It is not likely that other drugs you take orally or inject will have an effect on topically applied Altabax. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to retapamulin topical: topical ointment

Dermatologic

Common (1% to 10%): Pruritus, eczema
Uncommon (0.1% to 1%): Erythema, contact dermatitis, impetigo, excoriation[Ref]

Local

Common (1% to 10%): Application site irritation, application site pruritus, application site pain
Uncommon (0.1% to 1%): Application site erythema
Postmarketing reports: Application site burning sensation[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity events including angioedema[Ref]

Other

Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Increased creatinine phosphokinase[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea
Uncommon (0.1% to 1%): Abdominal discomfort[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Some side effects of Altabax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Safety has not been established Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown, however, exposure to the breastfeeding infant is likely to be negligible since minimal systemic exposure is observed in adults.