Drugs Effective Agains Gram Positive Rods
Linezolid: Its Part in the Handling of Gram-Positive, Drug-Resistant Bacterial Infections
Am Fam Physician. 2002 Feb fifteen;65(4):663-671.
Article Sections
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Problems Amid Gram-Positive Organisms
- Machinery of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparing to Quinupristin/Dalfopristin
- Concluding Comment
- References
While the choices available for the management of gram-positive, drug-resistant bacterial infections are condign limited, antimicrobial resistance is becoming increasingly problematic because of the widespread overuse of antibiotics. Linezolid is a synthetic antibiotic belonging to a new class of antimicrobials called the oxazolidinones. Linezolid disrupts bacterial growth by inhibiting the initiation process of protein synthesis—a mechanism of activeness that is unique to this class of drugs. It is well absorbed with high bioavailability that allows conversion to oral therapy every bit soon as the patient is clinically stable. It has been approved for certain gram-positive infections including certain drug-resistant enterococcus, staphylococcus, and pneumococcus strains. It is by and large well tolerated, with myelosuppression beingness the most serious adverse result. As a nonselective inhibitor of monoamine oxidase, caution is recommended when used with adrenergic or serotonergic agents (e.thousand., tyramine, dopamine, pseudoephedrine, and selective serotonin reuptake inhibitors). Judicious employ of this medication should assistance physicians treat patients with multidrug-resistant infections.
The growing antimicrobial resistance of certain microorganisms is now a worldwide business organisation. The introduction of penicillin in 1944 was soon followed by reports of resistance to Staphylococcus aureus. Physicians take encountered issues with antimicrobial resistance ever since. During the 1970s, the trouble of drug-resistant, gram-negative bacteria and of methicillin-resistant Due south. aureus emerged. Currently, the about pressing problem is that of multidrug-resistant, gram-positive leaner.
Factors Responsible for Antimicrobial Resistance
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Problems Amid Gram-Positive Organisms
- Machinery of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
Multiple factors contribute to the evolution of resistance to antibiotics. Their widespread and unnecessary utilize is the greatest contributing gene. It is estimated that 50 million pounds of antibiotics are taken annually in the United States1 and xxx pct of antibiotic prescriptions are for respiratory tract infections, more than i half of which were probably viral.2 The increasing problem of antimicrobial resistance in the hospital and the community parallels the over-prescribing of antibiotics. Other contributing factors that accept led to changes in virulence, and thus, the evolution of resistance to antibiotics, include societal changes (e.g., population growth and migration), an increasing number of immunosuppressed patients, the globalization of food supplies and changes in the mode food is grown and produced, human behavior (e.grand., widespread and frequent international travel), and environmental changes (including long-continuing use of antibiotics in fauna husbandry and agronomics).three
Resistance Bug Among Gram-Positive Organisms
- Abstruse
- Factors Responsible for Antimicrobial Resistance
- Resistance Issues Among Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Terminal Comment
- References
The increasing resistance amidst gram-positive species is apropos considering they are responsible for one 3rd of nosocomial infections.four During the past two decades, the prevalence of methicillin-resistant S. aureus increased from two.0 to 39.7 pct in the United states.5 Between 1980 and 1989, the incidence of bacteremia caused by coagulase-negative staphylococcal species, S. aureus, and enterococcus increased past 176 and 124 percent, respectively.6 These three pathogens are now the about common nosocomial-acquired causes of bacteremia. Surveillance data study that about 79 and 25 percent of nosocomially acquired, coagulase-negative staphylococcal species and S. aureus are methicillin-resistant, respectively.6
The enterococcus species is recognized as a major nosocomial pathogen. During the catamenia of methicillin-resistant South. aureus emergence, enterococci became the 3rd most common cause of nosocomial infections.5 In 1993, information technology was reported that 13.9 pct of all enterococcal isolates were resistant to vancomycin (Vancocin), representing a xx-fold increase from 1989.5 Previously, vancomycin was often considered the final therapeutic pick in cases in which resistance to all other antibiotics was present. Unfortunately, the arrival of vancomycin-resistant enterococcus changed this arroyo. Between 1990 and 1997, the percentage of enterococcal species resistant to vancomycin increased from less than 1 per centum to 18 percent.7 Enterococcus faecalis is responsible for 60 percent of these infections.eight A new threat of decreased susceptibility of S. aureus to vancomycin now exists.8 This emerging resistance to vancomycin is disturbing because it has been considered the terminal line of defence force.
Table 1
Common, Antibody-Resistant Microorganisms
| Community-acquired resistant Escherichia coli Haemophilus influenzae Methicillin-resistant Staphylococcus aureus Multidrug-resistant tuberculosis Neisseria gonorrhea Neisseria meningitidis Salmonella species Shigella species Streptococcus pneumoniae Streptococcus viridans | Nosocomial-resistant Bacteroides species Candida species Coagulase-negative staphylococci Enterobacter species Klebsiella species Methicillin-resistant Due south. aureus Multidrug-resistant tuberculosis Proteus species Pseudomonas aeruginosa Serratia species Vancomycin-resistant enterococci |
In the customs setting, many antibiotic-resistant leaner take emerged (Tabular array ane).5 The prevalence of drug-resistant Streptococcus pneumoniae has increased 60-fold since 1980 with 51 percent and eight percent of isolates demonstrating intermediate- or high-level resistance to penicillin or tertiary-generation cephalosporins, respectively.ix Thus, pneumococcal pneumonia is becoming more hard to treat with offset-line agents.
It is important to control the emergence of antimicrobial resistance and minimize the inappropriate use of antibiotics through education. This is not a minor task and requires a multidisciplinary approach. All health care professionals need to work toward the same goal. Some principles to control antimicrobial resistance are outlined in Table two.5
Against this background, newer therapeutic options are now available. Linezolid (Zyvox), a novel antimicrobial agent, has been approved by the U.Due south. Food and Drug Assistants (FDA) primarily to fight resistant gram-positive cocci, such as vancomycin-resistant enterococcus, methicillin-resistant Southward. aureus, and penicillin-resistant pneumococci. Antibiotic therapy for these resistant infections must be guided by laboratory testing; thus, appropriate cultures should be obtained to make up one's mind the causative organism(south) and its susceptibility to linezolid.
Mechanism of Action
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Problems Among Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
Linezolid is a synthetic antibiotic belonging to a new class of antimicrobials called the oxazolidinones. Linezolid disrupts bacterial growth by inhibiting the initiation process in protein synthesis. This site of inhibition occurs before in the initiation process than other protein synthesis inhibitors (due east.yard., chloramphenicol [Chloromycetin], clindamycin [Cleocin], aminoglycosides, and macrolides) that interfere with the elongation process.10,eleven Because the site of inhibition is unique to linezolid, cross-resistance to other protein synthesis inhibitors has non yet been reported.12 Linezolid may also inhibit virulence factor expression and decrease toxin production in gram-positive pathogens.13
It is preferable to use an amanuensis possessing bactericidal properties when possible. Information technology has been demonstrated that linezolid is bacteriostatic against enterococci and staphylococci, and bactericidal for the bulk of streptococci.14
Pharmacokinetics
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Bug Among Gram-Positive Organisms
- Machinery of Activity
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Terminal Comment
- References
Linezolid is highly absorbed when administered orally, with a bioavailability of approximately 100 percent.15 This allows conversion from intravenous to oral therapy as soon as the patient is clinically stable; thus, it provides an reward over comparative therapy that can be delivered only parenterally (i.e., vancomycin or quinupristin/dalfopristin [Synercid]). Linezolid is metabolized via hepatic oxidation without whatever cytochrome P-450 pathways. Elimination occurs through nonrenal, renal, and fecal mechanisms accounting for 65, 30, and 5 percent, respectively. The one-half-life is approximately five hours.15 Generally, the dosing interval for an antibiotic is three times the one-half-life—the dosing interval for linezolid is every 12 hours. Presently, no dosage adjustment is recommended for patients with renal insufficiency; even so, linezolid is removed past hemodialysis and should be administered following dialysis.14,fifteen
Indications
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Problems Amongst Gram-Positive Organisms
- Mechanism of Activity
- Pharmacokinetics
- Indications
- Dosing
- Agin Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparing to Quinupristin/Dalfopristin
- Terminal Comment
- References
The FDA has approved linezolid for sure gram-positive infections in developed patients (Table three).15 Other pathogens that linezolid has demonstrated in-vitro activeness confronting include penicillin-resistant S. pneumoniae, vancomycin-sensitive East. faecalis, vancomycin-resistant E. faecalis, methicillin-susceptible Staphylococcus epidermidis and methicillin-resistant Due south. epidermidis, Corynebacterium sp, Moraxella catarrhalis, legionella species Listeria monocytogenes, Pasteurella multocida, and Bacteroides fragilis.x,xvi
Because of limited clinical data demonstrating action against gram-negative organisms, it is recommended that coverage for these pathogens exist added when indicated.15 Clinical data in other special patient populations (i.e., children, pregnant women, or breastfeeding mothers) are limited. Linezolid is a pregnancy category C drug, and caution is urged if used in breastfeeding mothers. The safe and efficacy, and an appropriate dosage take non been established in children younger than 18 years.15 Utilise in these patient populations cannot be recommended at this time.
Tabular array two
Principles to Control Antimicrobial Resistance
| Advisable antimicrobial use | |
| Optimal use of antimicrobial agents—whether therapeutic, prophylactic, or empiric | |
| Brake of sure antimicrobial agents | |
| Rotation of antimicrobial therapy | |
| Combination of antimicrobial therapy | |
| Implementation of guidelines for mutual antibody use | |
| Antimicrobial resistance surveillance programs | |
| Prompt detection and reporting of new resistance patterns | |
| Rapid detection of resistant organisms | |
| Physicians and paramedical staff educational activity | |
| Figurer-based monitoring and feedback on use of microbial agents | |
| Multidisciplinary arroyo in decision-making antimicrobial resistance | |
| Professional person review of hospitals by oversight agencies such as the Joint Commission on Accreditation of Healthcare Organizations | |
Dosing
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Issues Among Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
The dosage regimen for linezolid is 400 mg or 600 mg every 12 hours for a duration of ten to 28 days, with an intravenous or oral road of administration, based on the indication (Table 4).xiv The 400-mg dose is approved for uncomplicated skin or pare structure infections; however, because many other antibiotic therapies are available, the authors strongly discourage the use of linezolid for this indication in social club to reduce the potential for developing bacterial resistance. The intravenous infusion should be administered over a period of 30 to 120 minutes.14 Several incompatibilities have been reported: amphotericin B (Fungizone), ceftriaxone (Rocephin), chlorpromazine (Thorazine), diazepam (Valium), erythromycin, phenytoin (Dilantin), and trimethoprim-sulfamethoxazole (Bactrim).17 Because compatibility information changes, information technology is recommended that a chemist be consulted when there is incertitude.
Adverse Furnishings
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Issues Among Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
Adverse effects reported in clinical trials in more than 2 percent of patients include the post-obit: rash, headache, diarrhea, nausea, vomiting, insomnia, constipation, and fever.15 The incidence was similar to the comparator groups: ceftriaxone, clarithromycin (Biaxin), dicloxacillin (Pathocil), oxacillin (Bactocill), and vancomycin.
Tabular array 3
FDA Indications for Utilise of Linezolid
| Vancomycin-resistant Enterococcus faecium, including cases with concurrent bacteremia |
| Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and resistant strains) or Streptococcus pneumoniae (penicillin-susceptible strains only) |
| Complicated skin and skin structure infections caused by S. aureus (methicillin-susceptible and resistant strains), Streptococcus pyogenes, Streptococcus agalactiae |
| Uncomplicated skin and skin construction infections caused by S. aureus (methicillin-susceptible strains only) or Due south. pyogenes |
| Community-acquired pneumonia acquired by S. pneumoniae (penicillin-susceptible strains but), including cases with concurrent bacteremia, or Due south. aureus (methicillin-susceptible strains only) |
Thrombocytopenia, defined as a decrease in platelet count below 75 percent of normal or baseline, was reported in 2.four percent of patients receiving linezolid versus 1.5 percent in those in the comparator grouping.14 This consequence may be associated with the college dose or handling elapsing exceeding 2 weeks.
In addition, the FDA has recently reported cases of myelosuppression (anemia, leukopenia, and pancytopenia) warranting the monitoring of hematologic parameters and has issued a warning that myelosuppression is considered a potential adverse consequence. The electric current recommendation is to monitor complete blood count status weekly, especially in patients receiving therapy longer than two weeks' elapsing, those with preexisting myelosuppression, those receiving drugs that produce bone marrow suppression, and those with a chronic infection who have received other antibiotic therapy recently or concurrently. If myelosuppression occurs, then discontinuation of therapy should be considered.
Drug-Drug Interactions
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Bug Among Gram-Positive Organisms
- Mechanism of Activeness
- Pharmacokinetics
- Indications
- Dosing
- Adverse Furnishings
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
Linezolid does non affect cytochrome P-450; therefore, induced interactions are unlikely to occur.10,11 No pharmacokinetic interaction was observed in patients taking warfarin (Coumadin) or phenytoin.xv
Linezolid is a reversible, nonselective inhibitor of monoamine oxidase (MOA), and a potential interaction with adrenergic or serotonergic agents is possible. A meaning pressor response was observed when administered with tyramine; therefore, patients should avert consuming food or beverages containing tyramine.14,15 More commonly used agents such as dopamine (Intropin), epinephrine, or decongestants containing pseudoephedrine may also produce an exaggerated pressor response. In healthy normotensive subjects receiving linezolid and pseudo-ephedrine, the mean maximum increment in systolic blood pressure was 32 mm Hg.11 Maximum elevation occurred at 2 to iii hours and returned to baseline within three hours. No bear on on eye rate was observed. Conscientious dosing titration is recommended when initiating dopamine or epinephrine.14
The potential for a serotonergic interaction with dextromethorphan (Robitussin DM) was evaluated in healthy subjects. No serotonin syndrome effects (confusion, delirium, tremors, restlessness, hyperpyrexia, or diaphoresis) were observed with this combination.14 No effects of serotonin syndrome were observed during a phase Iii study of 52 patients comparing fluoxetine, paroxetine and sertraline with linezolid.18 Nevertheless, caution is therefore recommended when using linezolid with agents such as citalopram (Celexa), fluvoxamine (Luvox), fluoxetine (Prozac), paroxetine (Paxil), or sertraline (Zoloft) until clinical safety is demonstrated.14,15
Clinical Studies
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Problems Among Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Agin Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
The FDA approved linezolid on the ground of nine unpublished, controlled clinical trials involving more than 4,000 patients.xix Most published trials are either in-vitro studies or clinical studies involving a pocket-sized sample size.
In all the therapeutic trials thus far, the 600-mg dosage was consistently more than effective in the treatment of patients with vancomycin-resistant enterococcus infections than was the 200-mg dosage. Intravenous linezolid at twice daily dosages of 600 mg produced a clinical cure rate of 88.6 percent compared with 73.seven percentage in the patients with vancomycin-resistant enterococcus infections who received 200 mg daily.xvi
TABLE 4
Linezolid (Zyvox) Dosing Recommendations
| Infection | Dosage/road | Recommended duration (days) |
|---|---|---|
| Nosocomial pneumonia | 600 mg IV or PO every 12 hours | 10 to 14 |
| Complicated skin/pare structure infections | As higher up | As above |
| Community-acquired pneumonia, including concurrent bacteremia | As above | Equally above |
| Vancomycin-resistantEnterococcus faecium infections, including concurrent bacteremia | 600 mg IV or PO every 12 hours | xiv to 28 |
| Uncomplicated skin/skin construction infections | 400 mg PO every 12 hours | 10 to 14 |
Results from a compassionate utilise trial involving treatment of patients with bacteremia for resistant, gram-positive infections reveal that linezolid was well tolerated.20 By the fifth 24-hour interval of the study, 75 percent of the bacteremia had resolved. It was concluded that linezolid is an excellent selection for the treatment of patients with pregnant, resistant gram-positive bacteremic infections.
Eighty-one patients with community-acquired pneumonia were treated with linezolid, resulting in a 98 percentage cure rate.21 Of note, biologic eradication was achieved in all evaluated patients infected with Southward. pneumoniae. Linezolid demonstrated similar efficacy to ceftriaxone and/or cefpodoxime proxetil, with a clinical cure rate of approximately 90 percent for customs-acquired pneumonia.16 Interestingly, linezolid was clinically and microbiologically superior to ceftriaxone in treating patients with concurrent bacteremia (93 percent in the linezolid group versus 69.9 percent in the ceftriaxone/cefpodoxime proxetil group).16
Linezolid (600 mg twice a day) and vancomycin (i thousand twice a mean solar day) are similarly condom and efficacious in the treatment of patients with nosocomial pneumonia, including methicillin-resistant South. aureus. Patients were treated for seven to 21 days, with cure rates of 66.4 per centum for patients treated with linezolid and 68.1 percentage for patients treated with vancomycin.22
Table 5
Comparison of Linezolid (Zyvox) to Quinupristin/Dalfopristin (Synercid)
| Drug/clinical significance | Machinery of action | FDA-approved spectrum of activity | Side-effect profile | FDA-approved indications | Dosage forms | Daily cost ($)* |
|---|---|---|---|---|---|---|
| Linezolid | Inhibits poly peptide synthesis at initiation pace. | Streptococcus pneumoniae (penicillin sensitive); Staphylococcus aureus (MSSA and MRSA); Streptococcus pyogenes; Streptococcus agalactiae; vancomycin-resistant Enterococcus faecium | Nausea, vomiting, thrombocytopenia (2.four per centum), myelosuppression | Vancomycin-resistant East. faecium infections; nosocomial pneumonia; complicated skin and pare structure infections; uncomplicated skin and skin construction infections; customs-acquired pneumonia | IV, PO (tablets, suspension) | Iv = 143.74; tablet = 106.26 (600 mg every 12 hours) |
| Quinupristin/dalfopristin | Inhibits protein synthesis at elongation step, similar to aminoglycosides, clindamycin (Cleocin), and chloramphenicol (Chloromycetin). | S. aureus (MSSA); S. pyogenes; vancomycin-resistant Enterococcus faecium | Phlebitis, arthralgias/myalgias, hyperbilirubinemia (25 percent) | Vancomycin-resistant E. faecium infections; complicated skin and skin structure infections | IV | IV = 322.28 (500 mg every eight hours) |
| Clinical significance | Like site of inhibition may allow cross-resistance between Q/D, aminoglycosides, clindamycin, and chloramphenicol. | Q/D is not FDA approved for MRSA infections. Although not FDA approved for Enterococcus faecalis, linezolid has in-vitro activity against this pathogen. Q/D is not active against Due east. faecalis. | Lower infusion-related side effects with linezolid | Broader FDA indications may allow clinicians to feel more comfortable prescribing linezolid. | Allows opportunity for conversion to oral therapy for outpatient treatment with linezolid | — |
Linezolid therapy has been plant to cure or ameliorate more than than 90 per centum of patients treated for pare and soft tissue infections.sixteen The 400-mg and 600-mg dosages twice daily produced clinical success rates exceeding 89 percent in patients with complicated and unproblematic peel/soft tissue infections.16 Linezolid too exhibited like efficacy to oxacillin (Bactocill)/dicloxacillin and vancomycin.16
Comparison to Quinupristin/Dalfopristin
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Issues Amongst Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Concluding Annotate
- References
Quinupristin/dalfopristin (Synercid) was recently approved by the FDA for the treatment of patients with vancomycin-resistant Enterococcus faecium, methicillin-susceptible and methicillin-resistant infections. Although no randomized clinical trials have compared these agents, several notable differences exist (Table five).
Final Comment
- Abstract
- Factors Responsible for Antimicrobial Resistance
- Resistance Bug Amid Gram-Positive Organisms
- Mechanism of Action
- Pharmacokinetics
- Indications
- Dosing
- Adverse Effects
- Drug-Drug Interactions
- Clinical Studies
- Comparison to Quinupristin/Dalfopristin
- Final Comment
- References
The oxazolidinones is a new class of antibiotics that are effective against many resurgent gram-positive organisms. The first of the oxazolidinones, linezolid, is available as an intravenous or oral agent. Its loftier bioavailability allows initial oral therapy for many infections and a convenient switch from intravenous to oral therapy when indicated. In addition, the every 12 hours dosing schedule improves compliance. Parallel to the increasing resistance among the common pathogens, linezolid is an exciting therapeutic option.
Nevertheless, at that place is no reason to believe that resistance volition non emerge. This will depend on how responsibly and oftentimes linezolid is prescribed and how quickly leaner tin evolve a new defense. Every bit emphasized earlier, linezolid should exist reserved for the treatment of patients with infections caused by multidrug-resistant leaner that are proved past laboratory testing, and to life-threatening or complicated infections associated with multiple resistances to kickoff-line treatments. Thus far, it has demonstrated activity against all clinically significant, gram-positive bacteria. With its role in multidrug-resistant leaner, linezolid will play a crucial role in both the community and the nosocomial setting. Physicians should prescribe this agent judiciously so equally to minimize antimicrobial resistance.
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xx. Birmingham MC, Zimmer GS, Flavin SM, Rayner CR, Welch KE, Smith PF, et al. Results of treating bacteremic patients with linezolid in a compassionate employ trial for resistant, gram-positive infections. The Clinical Pharmacokinetics Laboratory, Kaleida Health/Millard Fillmore Hospital and SUNY at Buffalo, NY, USA. Retrieved May 2001, from: http://www.icmask.org/icmasko5/abstracts.cgi?number=viii.24.
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Richard W. Sloan, K.D., R.Ph., coordinator of this series, is chairman and residency programme managing director of the Department of Family Medicine at York (Pa.) Hospital and clinical associate professor in family unit and community medicine at the Milton S. Hershey Medical Center, Pennsylvania Country University, Hershey, Pa.
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