Treatment of acute bacterial skin and skin structure infections caused by or suspected to be caused by susceptible designated Gram-positive bacteria.
Binds to bacterial cell wall resulting in cell death.
Bactericidal action against susceptible bacteria with resolution of infection.
Active against Staphylococcus aureus (including methicillin-susceptible and resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus (including S. anginosus, S. intermidius, and S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains only).
Absorption: IV administration results in complete bioavailability.
Distribution: Penetrates skin/skin structures.
Metabolism and Excretion: Slowly excreted unchanged in urine (5% in two weeks) and feces (1% in two weeks).
Half-life: 245 hr (terminal).
TIME/ACTION PROFILE (blood levels)
end of infusion
at least 2 wk
Hypersensitivity (cross-sensitivity with other glycopeptides may occur);
Heparin use for 120 hr (5 days) following administration of oritavancin (causes false ↑ aPTT);
Concurrent warfarin (↑ risk of bleeding, use only if benefit outweighs bleeding risk);
Concurrent use of drugs with narrow therapeutic indices that are metabolized by the CYP450 enzyme system (effects may be altered);
Severe hepatic/renal impairment;
Geri: Elderly patients may be ↑ sensitive to drug effects;
OB: Use during pregnancy only if potential benefit justifies fetal risk;
Lactation: Use cautiously if breast feeding;
Pedi: Safety and effectiveness not established.
Adverse Reactions/Side Effects
GI: diarrhea including clostridium difficile, ↑ liver enzymes, nausea, vomiting
Local: infusion site reactions
Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, infusion reactions including "Red-Man Syndrome,", limb/subcutaneous abscess formation
* CAPITALS indicate life-threatening. Underline indicate most frequent.
↑ risk of bleeding with warfarin (avoid if possible).
Affects the activities of several CYP450 enzymes (careful monitoring of other drugs metabolized by the CYP450 system that have narrow therapeutic indices to assess for toxicity or ineffectiveness is recommended).
IV: (Adults >18 yr): 1200 mg single dose.
Lyophylized powder for injection: 400 mg/vial
Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
Obtain specimens for culture and sensitivity prior to therapy. First dose may be given before receiving results.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridium difficile-associated diarrhea (CDAD). May begin up to 2 mo following cessation of therapy.
Monitor for infusion reactions (Red-man syndrome–flushing of upper body, urticaria, pruritus, rash). May resolve with stopping or slowing infusion.
Lab Test Considerations: Monitor hepatic function tests. May cause ↑ ALT, AST, and bilirubin.
May cause hyperuricemia and hypoglycemia.
Causes falsely ↑ aPTT for 120 hrs after infusion. Avoid heparin administration during this time. Use a non-phospholipid dependent coagulation test such as Factor Xa assay if needed.
Artificially prolongs PT and INR for up to 12 hr. May increase risk of bleeding with warfarin.
Using three 400 mg vials, add 40 mL of Sterile Water for Injection to each vial for a 10 mg/mL solution/vial. Swirl gently to avoid foaming and ensure powder is completely reconstituted. Solution is clear and colorless to pale yellow; do not administer solutions that are discolored or contain particulate matter. Diluent: Withdraw and discard 120 mL from 1000 mL bag of D5W. Withdraw 40 mL from each vial and add to D5W bag. Do not use 0.9% NaCl; may cause precipitation.Concentration: 1.2 mg/mL. Use within 6 hr at room temperature or 12 hr if refrigerated, including 3 hr infusion.
Rate: Infuse over 3 hr.
Y-Site Incompatibility: Do not mix with other solutions or medications. Flush line before and after infusion.
Instruct patient to notify health care professional if signs and symptoms of hypersensitivity reactions (rash, hives, dyspnea, facial swelling) occur.
Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
Instruct the patient to notify health care professional if symptoms do not improve.
Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
oritavancin is a sample topic from the Davis's Drug Guide.
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