Data will be presented on ORBACTIVTM (oritavancin) for injection, the first and only single-dose
Results from studies on ORBACTIV (Abstract L-1729) and Carbavance (Abstract C-1193) will be featured in an ICAAC press briefing. Additionally, two oral presentations highlighting the results from studies with the novel beta-lactamase inhibitor RPX7009 will be given in the session "New Insights into Beta-lactamase/Beta-lactamase Inhibitor Combinations" on
Copies of abstracts and scheduled presentations are available on the ICAAC 2014 website: http://www.icaac.org/ About the Medicines Company Infectious Disease Portfolio The
ORBACTIV is the first and only single-dose antibiotic approved for commercial use in the US. The EMA accepted for review the Marketing Authorization Application (MAA) for ORBACTIV in Q1 2014, for which the Company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the
ORBACTIV is contraindicated in patients with known hypersensitivity to ORBACTIV. Warnings and Precautions Concomitant warfarin use: Co-administration of ORBACTIV and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.
Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 hours.
Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.
Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops. Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.
Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
Prescribing ORBACTIV 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. Adverse Reactions The most common adverse reactions (= 3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
Please see www.orbactiv.com for the full prescribing information. About MINOCINŽ IV (minocycline for injection) MINOCINŽ IV (minocycline for injection) is
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.
Central nervous system side effects including lightheadedness, dizziness or vertigo have been reported.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Precautions As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Keywords for this news article include: Antibacterial, Antibiotics, Antimicrobials, Bacterial Drug Resistance, Central Nervous System Diseases, Chemotherapy, Clostridium difficile, Diarrhea, Drugs, Gram-Positive Endospore-Forming Rods, Hydrocarbons, Hypersensitivity, Infectious Diseases, Microbial Drug Resistance, Minocycline, Naphthacenes, Obstetrics, Pregnancy, Tetracyclines,
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