retapamulin (Rx)

Brand and Other Names:Altabax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ointment

  • 1% (5, 10, 15g tubes)

Impetigo

Indicated for impetigo caused by MSSA or Streptococcus pyogenes

Apply thin layer to affected area (up to 100 cm²) BID x5 days

Dosage Forms & Strengths

ointment

  • 1% (5, 10, 15g tubes)

Impetigo

Indicated for impetigo caused by MSSA or Streptococcus pyogenes

<9 months: Safety and efficacy not established

≥9 months: Apply thin layer to affected area (up to 2% BSA) BID x5 days

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Adverse Effects

1-10%

Application site irritation (2%)

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Warnings

Contraindications

None

Cautions

Not for oral, intranasal, ophthalmic or intravaginal use; efficacy and safety for mucosal surfaces not established

Discontinue if sensitization or severe local irritation develops

Epistaxis reported with use on nasal mucosa

Not evaluated on mucosal surfaces

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Pregnancy & Lactation

Pregnancy

There are no available data on use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; drug is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure

Animal data

  • Animal reproduction studies were not conducted with drug; however, in animal studies where drug was administered by oral gavage or intravenous infusion to pregnant rats and rabbits, respectively, during organogenesis, maternal toxicity was seen at doses ≥150 mg/kg/day and 7.2 mg/kg/day (8-fold the maximum achievable human exposure based on AUC) for oral and intravenous routes, respectively

Lactation

There are no data available on presence of drug in human milk, its effects on breastfed infant or on milk production; however, breastfeeding is not expected to result in exposure of child to drug due to negligible systemic absorption in humans following topical administration of drug

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Pleuromutilin antibacterial; binds to 50S ribosomal subunit and inhibits bacterial protein synthesis, bateriostatic at MIC; bactericidal at 1000x MIC

Pharmacokinetics

Absorption: Low

Protein Bound: 94%

Metabolism: in vitro by liver CYP3A4

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Altabax topical
-
1 % ointment
Altabax topical
-
1 % ointment

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
retapamulin topical

RETAPAMULIN 1% OINTMENT - TOPICAL

(RE-te-PAM-ue-lin)

COMMON BRAND NAME(S): Altabax

USES: Retapamulin is used to treat a certain skin infection (impetigo) caused by bacteria. It is an antibiotic that works by stopping the growth of certain bacteria (Staphylococcus and Streptococcus) on the skin.

HOW TO USE: Use this medication on the skin only. Clean and dry the affected area first. Then apply a small amount of ointment to the affected area, usually 2 times a day for 5 days or as directed by your doctor. Wash your hands after applying unless you are treating an area on the hands.Do not use this medication around the eyes, nose, mouth, or vaginal area, or on large areas of skin, unless otherwise directed by your doctor. You may cover the treated area with a bandage/gauze. This may help prevent your child from accidentally getting the medication in their eyes, nose, or mouth.Use this medication regularly in order to get the most benefit from it. Continue to use it for the full time prescribed. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.You should see some improvement (healed/dry sores, decreased redness) in 3 to 4 days. Tell your doctor if your condition does not improve in 3 to 4 days.

SIDE EFFECTS: Mild burning, stinging, or itching may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: blistering/swelling/oozing skin.Use of this medication for prolonged or repeated periods may result in a new infection (such as a fungal infection). Contact your doctor if you notice signs of a new infection (such as new/worsening sores, fever).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using retapamulin, tell the doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell the doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.