Zyvox: Potent Gram-Positive Antibiotic for Resistant Infections
Zyvox
| Product dosage: 600mg | |||
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| 60 | $7.05
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Synonyms | |||
Zyvox (linezolid) is a synthetic antibacterial agent of the oxazolidinone class, specifically indicated for the treatment of adults and children with infections caused by susceptible strains of designated Gram-positive microorganisms. It represents a critical therapeutic option, particularly for infections due to vancomycin-resistant Enterococcus faecium (VRE) and complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Its unique mechanism of action and availability in both intravenous and oral formulations make it a versatile agent in both hospital and outpatient settings, bridging a significant gap in antimicrobial therapy for multidrug-resistant organisms.
Features
- Active Ingredient: Linezolid
- Pharmacologic Class: Oxazolidinone-class antibacterial
- Available Formulations: 600 mg film-coated tablets; 100 mg/5 mL oral suspension; 2 mg/mL intravenous injection
- Mechanism of Action: Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis
- Spectrum of Activity: Gram-positive bacteria including Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Enterococcus faecium (vancomycin-resistant strains)
- Bioavailability: Approximately 100% following oral administration, permitting seamless IV-to-oral transition
Benefits
- Provides potent bactericidal activity against multidrug-resistant Gram-positive pathogens, including MRSA and VRE, where treatment options are limited.
- Offers excellent oral bioavailability, enabling early transition from IV therapy in appropriate patients, potentially reducing hospital length of stay and associated costs.
- Demonstrates a unique mechanism of action that minimizes the risk of cross-resistance with other antibiotic classes, preserving its efficacy.
- Effective in treating a range of serious infections, including nosocomial pneumonia, complicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections.
- Supported by robust clinical trial data demonstrating high clinical cure rates in approved indications.
- Available in both adult and pediatric formulations, allowing for tailored dosing across patient populations.
Common use
Zyvox is indicated for the treatment of the following infections caused by susceptible strains of designated Gram-positive microorganisms:
- Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae
- Complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae
- Vancomycin-resistant Enterococcus faecium infections
- Community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains) or Staphylococcus aureus (methicillin-susceptible strains only)
- Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes
Its use should be reserved for situations where the benefits outweigh the risks, particularly given concerns regarding myelosuppression and potential for development of resistance.
Dosage and direction
Adults:
- 600 mg intravenously or orally every 12 hours for 10 to 14 days for most indications. Duration may be extended up to 28 days for specific infections like vancomycin-resistant Enterococcus faecium.
- For uncomplicated skin and skin structure infections: 400 mg orally every 12 hours.
Pediatric Patients:
- Birth to 11 years: 10 mg/kg intravenously or orally every 8 hours.
- 12 years and older: 600 mg intravenously or orally every 12 hours.
Dosage adjustment is not routinely required in patients with renal impairment or mild to moderate hepatic impairment. The oral suspension should be gently inverted 3-5 times before each dose, not shaken. Zyvox may be taken with or without food.
Precautions
- Myelosuppression: Zyvox has been associated with reversible myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia). Complete blood counts should be monitored weekly, especially in patients receiving therapy longer than 2 weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that may cause bone marrow suppression, or those with chronic infections who have received previous or concomitant antibiotic therapy.
- Serotonin Syndrome: Spontaneous reports of serotonin syndrome have been reported in patients receiving Zyvox and concomitant serotonergic agents. Patients should be closely monitored for signs and symptoms such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination.
- Peripheral and Optic Neuropathy: Cases of peripheral and optic neuropathy have been reported, primarily in patients treated for longer than the maximum recommended duration of 28 days. If symptoms of visual impairment or peripheral neuropathy occur, prompt ophthalmic and neurological evaluation is recommended.
- Lactic Acidosis: Cases of lactic acidosis have been reported. Unexplained metabolic acidosis or low bicarbonate levels should prompt immediate evaluation.
- Clostridioides difficile-Associated Diarrhea (CDAD): CDAD has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
- Hypertension: Monitor blood pressure in patients receiving Zyvox, as hypertension has been reported.
Contraindications
Zyvox is contraindicated in patients with known hypersensitivity to linezolid or any other component of the product. It should not be used in patients taking any monoamine oxidase inhibitors (MAOIs) or within two weeks of taking an MAOI due to the risk of precipitating a hypertensive crisis. It is also contraindicated in patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, and/or those taking directly and indirectly acting sympathomimetic agents, vasopressive agents, and dopaminergic agents unless patients can be closely monitored for changes in blood pressure.
Possible side effect
The most common adverse reactions (incidence ≥5% in adults) include:
- Diarrhea
- Nausea
- Headache
- Vomiting
Other important adverse reactions include:
- Myelosuppression (anemia, leukopenia, pancytopenia, thrombocytopenia)
- Peripheral neuropathy
- Optic neuropathy (sometimes progressing to vision loss)
- Lactic acidosis
- Serotonin syndrome (with concomitant serotonergic drugs)
- Tongue discoloration
- Oral moniliasis
- Vaginal moniliasis
- Hypertension
- Increased hepatic transaminases
- Skin rash
- Insomnia
- Dizziness
Drug interaction
- Monoamine Oxidase Inhibitors (MAOIs): Contraindicated due to risk of hypertensive crisis.
- Serotonergic Agents (e.g., SSRIs, SNRIs, TCAs, triptans, meperidine, buspirone): Increased risk of serotonin syndrome. Avoid concomitant use unless clinically warranted and close monitoring is possible.
- Adrenergic Agents (e.g., pseudoephedrine, phenylpropanolamine): May potentiate pressor response. Monitor blood pressure.
- Dopaminergic Agents (e.g., dopamine, dobutamine, epinephrine): May potentiate pressor response. Monitor blood pressure and adjust vasopressor dosage as needed.
- Tyramine-Rich Foods: While a strict tyramine-free diet is not required, patients should be advised to avoid large quantities of tyramine-rich foods (aged cheeses, fermented meats, etc.) as Zyvox has weak MAOI activity.
Missed dose
If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed. Do not double the dose to make up for a missed one. Maintaining consistent 12-hour intervals is important for ensuring adequate antimicrobial coverage.
Overdose
There is no specific antidote for Zyvox overdose. Reported cases of acute overdose have been limited. Management should include supportive care, maintaining glomerular filtration, and observation for potential adverse effects such as myelosuppression, lactic acidosis, or neurological effects. Hemodialysis may accelerate elimination, as approximately 30% of a dose is removed in 3 hours of hemodialysis.
Storage
- Tablets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in original container and protect from light and moisture.
- Oral Suspension: Store dry powder at 20°C to 25°C (68°F to 77°F). After reconstitution with water, store at room temperature and use within 21 days. Do not freeze.
- Intravenous Injection: Store at 20°C to 25°C (68°F to 77°F). Protect from light and freezing. The diluted solution for IV infusion is clear and colorless to yellow; discard if particulate matter or discoloration is observed.
Disclaimer
This information is intended for healthcare professionals and is a summary of essential product data. It does not encompass all available information. The prescribing physician should be thoroughly familiar with the full Prescribing Information before initiating therapy. The choice of antibacterial therapy should be based on culture and susceptibility testing where possible. Zyvox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria.
Reviews
Zyvox is consistently rated highly in clinical practice for its efficacy against challenging multidrug-resistant Gram-positive infections. Specialists in infectious diseases often note its critical role as a “reserve” agent, particularly praising its 100% oral bioavailability which facilitates outpatient parenteral antimicrobial therapy (OPAT) programs. Published clinical trial data and real-world evidence support its high clinical cure rates in complicated skin and soft tissue infections and nosocomial pneumonia. However, experts universally emphasize the importance of vigilant monitoring for hematological and neurological adverse events, especially with prolonged courses. Its cost is often cited as a consideration, but its value is recognized in scenarios where it prevents complications, longer hospitalizations, or treatment failures associated with other agents.