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Drugs reference index «Retapamulin»

Retapamulin


Retapamulin

Pronunciation: (RE-te-PAM-ue-lin)Class: Antibacterial agent

Trade Names:Altabax- Ointment 10 mg/g

Pharmacology

Selectively inhibits bacterial protein synthesis, inhibiting peptidyl transfer, blocking P-site interactions, and preventing normal formation of active 50S ribosomal subunits.

Pharmacokinetics

Absorption

Systemic exposure after topical application to intact and debrided skin is low. Following twice-daily topical application, 11% of patients had measurable retapamulin concentrations with a median concentration of 0.8 ng/mL.

Distribution

Protein binding is approximately 94%.

Metabolism

In vitro studies indicate that CYP3A4 is the major enzyme responsible for the metabolism of retapamulin to numerous metabolites.

Indications and Usage

Topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes .

Contraindications

None known.

Dosage and Administration

Adults

Topical Apply a thin layer to affected area (up to 100 cm 2 in total area) twice daily for 5 days.

Children 9 mo of age and older

Topical Apply a thin layer to affected area (or 2% of total body surface area) twice daily for 5 days.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

CYP3A4 inhibitors (eg, ketoconazole)

Retapamulin plasma levels may be increased; however, dosage adjustments are unnecessary.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (2%).

Dermatologic

Pruritus (2%); eczema (1%).

EENT

Nasopharyngitis (2%).

GI

Diarrhea (2%); nausea (1%).

Local

Application-site irritation (2%).

Miscellaneous

Pyrexia (1%).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 9 months of age.

Superinfection

May promote overgrowth of nonsusceptible microorganisms.

Local irritation

If sensitization or severe local irritation occurs, discontinue use and wipe off ointment.

Mucosal or systemic use

Not intended for ingestion or oral, intranasal, ophthalmic, or intravaginal use, or for use on mucosal surfaces.

Overdosage

Symptoms

Has not been reported.

Patient Information

  • Advise patient that product is not intended for ingestion or oral, intranasal, ophthalmic, or intravaginal use, or for use on mucosal surfaces (eg, lips, mouth, inside nose).
  • Advise patient that treated area may be covered by a sterile bandage or gauze dressing, if desired.
  • Instruct patients to use product for the full time recommended by health care provider, even if symptoms have improved.
  • Instruct patients to notify health care provider if there is no improvement in symptoms within 3 to 4 days of starting treatment.
  • Instruct patients to notify health care provider if irritation, redness, itching, burning, swelling, blistering, or oozing worsens in the area applied.

Copyright © 2009 Wolters Kluwer Health.

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