Altabax

Name: Altabax

What should I do if I forget a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra ointment to make up for a missed dose.

Overdose

Overdosage with ALTABAX has not been reported. Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically consistent with good clinical practice.

There is no known antidote for overdoses of ALTABAX.

Altabax Drug Class

Altabax is part of the drug class:

  • Other antibiotics for topical use

What is retapamulin topical?

Retapamulin is an antibiotic that fights bacteria on the skin.

Retapamulin topical (for the skin) is used to treat an infection called impetigo (im-pe-TYE-go). Impetigo usually affects the nose, lips, or other areas of the face, but it may also affect other areas of the body.

Retapamulin may be used for purposes not listed in this medication guide.

Proper Use of Altabax

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away .

Wash your hands with soap and water before using this medicine. Also wash your hands with soap and water after using this medicine if the hands are not the area for treatment .

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly. Then apply a thin layer to the affected area and rub in gently .

After applying this medicine, the treated area may be covered with a sterile bandage or gauze dressing if desired .

Keep using this medicine for the full treatment time, even if your symptoms have improved after the first few doses. Your infection may not clear up if you stop using the medicine too soon .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (ointment):
    • For impetigo:
      • Adults and children 9 months of age and older—Apply to the affected area of the skin two times a day for 5 days.
      • Children below 9 months of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What are some things I need to know or do while I take Altabax?

  • Tell all of your health care providers that you take Altabax. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
  • Do not use longer than you have been told. A second infection may happen.
  • Talk with your doctor before you use other drugs or products on your skin.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Contraindications

None.

Use in specific populations

Pregnancy

Pregnancy Category B.

Effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg per kg per day by oral gavage on Days 6 to 17 postcoitus. Maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses greater than or equal to 150 mg per kg per day. There were no treatment-related malformations observed in fetal rats.

Retapamulin was given as a continuous intravenous infusion to pregnant rabbits at dosages of 2.4, 7.2, or 24 mg per kg per day from Day 7 to 19 of gestation. Maternal toxicity (decreased body weight gain, food consumption, and abortions) was demonstrated at dosages greater than or equal to 7.2 mg per kg per day (8-fold the estimated maximum achievable human exposure, based on AUC, at 7.2 mg per kg per day). There was no treatment-related effect on embryo-fetal development.

There are no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, Altabax should be used in pregnancy only when the potential benefits outweigh the potential risk.

Nursing Mothers

It is not known whether retapamulin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Altabax is administered to a nursing woman. The safe use of retapamulin during breastfeeding has not been established.

Pediatric Use

The safety and effectiveness of Altabax in the treatment of impetigo have been established in pediatric patients aged 9 months to 17 years. Use of Altabax in pediatric patients (9 months to 17 years of age) is supported by evidence from adequate and well-controlled trials of Altabax in which 588 pediatric subjects received at least one dose of retapamulin ointment, 1% [see Adverse Reactions (6.1), Clinical Studies (14)]. The magnitude of efficacy and the safety profile of Altabax in pediatric subjects 9 months and older were similar to those in adults.

The safety and effectiveness of Altabax in pediatric patients younger than 9 months have not been established. An open-label clinical trial of topical treatment with Altabax (twice daily for 5 days) was conducted in subjects aged 2 to 24 months. Plasma samples were obtained from 79 subjects. In these pediatric subjects, systemic exposure of retapamulin was higher compared with subjects aged 2 to 17 years. Furthermore, a higher proportion of pediatric subjects aged 2 to 9 months had measurable concentrations (greater than 0.5 ng per mL) of retapamulin compared with subjects aged 9 to 24 months [see Pharmacokinetics (12.3)]. The highest levels were seen in subjects aged 2 to 6 months [see Pharmacokinetics (12.3)]. The use of retapamulin is not indicated in pediatric patients younger than 9 months.

Geriatric Use

Of the total number of subjects in the adequate and well-controlled trials of Altabax, 234 subjects were aged 65 years and older, of whom 114 subjects were aged 75 years and older. No overall differences in effectiveness or safety were observed between these subjects and younger adult subjects.

References

  1. Clinical and Laboratory Standards Institute (CLSI) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically: Approved Standard-Eighth Edition. CLSI Document M07-A9, Vol. 32, No. 2. CLSI, Wayne, PA, Jan. 2012.
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: Nineteenth Informational Supplement. CLSI Document M100-S22. Vol. 32, No. 3. CLSI, Wayne, PA, Jan. 2012.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests. Approved Standard-Tenth Edition. CLSI Document M02-A11, Vol. 32, No. 1. CLSI, Wayne, PA, Jan. 2012.

Patient Counseling Information

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.

Altabax is a registered trademark of Aqua Pharmaceuticals.

AQUA PHARMACEUTICALS
an Almirall company

Manufactured by: GlaxoSmithKline
Barnard Castle, County Durham, DL12 8DT, United Kingdom
Manufactured for: Aqua Pharmaceuticals, an Almirall Company, Exton, PA 19341
© 2015 Aqua Pharmaceuticals. All rights reserved.
November 2015

What is retapamulin topical (altabax)?

Retapamulin is an antibiotic that fights bacteria on the skin.

Retapamulin topical (for the skin) is used to treat an infection called impetigo (im-pe-TYE-go). Impetigo usually affects the nose, lips, or other areas of the face, but it may also affect other areas of the body.

Retapamulin may be used for purposes not listed in this medication guide.

What should i avoid while using retapamulin topical (altabax)?

Impetigo is highly contagious and spreads easily from person to person. Avoid sharing personal items such as towels, washcloths, or razors with other people if you are infected with impetigo. Use a clean towel and washcloth each time you bathe to keep from reinfecting your own skin.

Avoid getting this medication in your eyes, nose, or mouth, or inside your vagina. If this does happen, rinse with water.

Avoid using other medications on the areas you treat with retapamulin topical unless your doctor tells you to.

Side effects

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.

Read the entire FDA prescribing information for Altabax (Retapamulin)

Read More »

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Altabax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Altabax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. 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.

Less serious Altabax side effects may include:

  • mild skin irritation;

  • nausea, diarrhea;

  • headache; or

  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Retapamulin Levels and Effects while Breastfeeding

Summary of Use during Lactation

No information is available on the use of retapamulin during breastfeeding. Because retapamulin is poorly absorbed after topical application, it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants after maternal application away from the breast. Only water-miscible cream or gel products should be applied to the breast, because ointments may expose the infant to high levels of mineral paraffins via licking.[1]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482

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