Medication info

Zyvok 2 mg/mL (Linezolid)

Prescription medication
Ingredient · strength
Linezolid›2mg / 1mL
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
A transparent injection solution ranging from colorless to yellow in an infusion bag.
Packaging
300 mL/pack X 1
Approval status
Active

MFDS item code 200705482 · Approved 2006.09.11 · Insurance code 648900721

Summary

Main use
Treatment of vancomycin-resistant enterococcal infections, pneumonia, and skin and soft tissue infections
Who uses it
Adults · Children
Adult dosage
Adolescents and adults (12 years of age and older) Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), and complicated skin and soft tissue infections: 600 mg intravenously or orally every 12 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections Adults: 400 mg orally every 12 hours Adolescents (12 ∼ 17 years of age): 600 mg orally every 12 hours For 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): 600 mg intravenously or orally every 12 hours for 14 ∼ 28 consecutive days Adult patients with infections caused by MRSA should receive 600 mg of this medication every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dose adjustment is necessary when switching from the intravenous formulation to the oral formulation. Patients who started treatment with the injectable formulation may be switched to tablets or syrup at the physician's discretion if clinically indicated.
Children's dosage
Children (newborns to 11 years of age) Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), and complicated skin and soft tissue infections: 10 mg per kg of body weight intravenously or orally every 8 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections — under 5 years of age: 10 mg per kg of body weight orally every 8 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections — 5 ∼ 11 years of age: 10 mg per kg of body weight orally every 12 hours for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): 10mg per kg of body weight intravenously or orally every 8 hours for 14 ∼ 28 consecutive days Newborns less than 7 days old: Most preterm neonates less than 7 days old (born at 34 weeks' gestation or earlier) have lower systemic clearance and higher AUC for this medication than full-term neonates and infants. These neonates should be started on 10 mg per kg of body weight every 12 hours. Newborns less than 7 days old: For neonates whose clinical response is less than optimal, administration of 10 mg per kg every 8 hours may be considered. All newborn patients should receive 10 mg per kg of body weight every 8 hours until 7 days of age.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

Treatment of vancomycin-resistant enterococcal infections, pneumonia, and skin and soft tissue infections

  • Hospital-acquired pneumonia
  • community-acquired pneumonia
  • bacteremia
  • skin and soft tissue infections
  • diabetic foot infections
  • skin and soft tissue infections not accompanied by osteomyelitis
  • vancomycin-resistant Enterococcus faecium infections.
View approved original text

This medication is primarily used to treat infections caused by certain gram-positive bacteria. It is particularly effective for pneumonia acquired in hospitals and communities, skin and soft tissue infections, and infections caused by vancomycin-resistant Enterococcus faecium. It is also used for skin infections that are accompanied by complications such as diabetic foot infections, and it is suitable when osteomyelitis is not present. However, special treatment may be necessary for gram-negative bacterial infections, so caution is required. This medication is used safely and effectively for the treatment of bacterial infections.

Dosage and Administration

Adult dosage

Adolescents and adults (12 years of age and older) Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), and complicated skin and soft tissue infections: 600 mg intravenously or orally every 12 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections Adults: 400 mg orally every 12 hours Adolescents (12 ∼ 17 years of age): 600 mg orally every 12 hours For 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): 600 mg intravenously or orally every 12 hours for 14 ∼ 28 consecutive days Adult patients with infections caused by MRSA should receive 600 mg of this medication every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dose adjustment is necessary when switching from the intravenous formulation to the oral formulation. Patients who started treatment with the injectable formulation may be switched to tablets or syrup at the physician's discretion if clinically indicated.

Children's dosage

Children (newborns to 11 years of age) Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), and complicated skin and soft tissue infections: 10 mg per kg of body weight intravenously or orally every 8 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections — under 5 years of age: 10 mg per kg of body weight orally every 8 hours for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections — 5 ∼ 11 years of age: 10 mg per kg of body weight orally every 12 hours for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): 10mg per kg of body weight intravenously or orally every 8 hours for 14 ∼ 28 consecutive days Newborns less than 7 days old: Most preterm neonates less than 7 days old (born at 34 weeks' gestation or earlier) have lower systemic clearance and higher AUC for this medication than full-term neonates and infants. These neonates should be started on 10 mg per kg of body weight every 12 hours. Newborns less than 7 days old: For neonates whose clinical response is less than optimal, administration of 10 mg per kg every 8 hours may be considered. All newborn patients should receive 10 mg per kg of body weight every 8 hours until 7 days of age.

Precautions

This medication may suppress bone marrow function, leading to blood-related issues such as anemia or thrombocytopenia. Thrombocytopenia may occur more frequently in patients with severely impaired kidney or liver function, therefore patients using this medication for more than 2 weeks or those with a history of bone marrow suppression should undergo regular blood tests. Additionally, if diarrhea occurs after using this medication, a serious intestinal condition called pseudomembranous colitis may develop, and if signs of diarrhea appear, the doctor should be notified immediately. Pseudomembranous colitis can range from mild to life-threatening serious cases. This medication is not effective against gram-negative bacteria; therefore, if there is suspicion or confirmation of gram-negative bacterial infections, other appropriate treatments should be sought. It should also not be used for bloodstream infections treated via central venous catheters. Diabetes patients using this medication in conjunction with insulin or hypoglycemic agents should monitor blood sugar closely to avoid a risk of hypoglycemia; dosage adjustments may be necessary. Patients with allergies to this medication or its components, patients who have taken MAO inhibitors within the last 2 weeks, or patients with uncontrolled hypertension or specific psychiatric conditions should not receive this treatment. This medication may interact with other drugs that can increase blood pressure; therefore, patients currently taking such medications should consult their doctor. Prolonged usage may cause vision changes or nerve damage; if there are any visual disturbances, an eye examination should be sought immediately, and caution is advised if any neurological symptoms occur. Pregnant women or those who may become pregnant should consult their doctor before use, as there may be risks to the fetus, and breastfeeding mothers should stop nursing before use. This medication can be used without dosage adjustment in patients with severely impaired kidney function, but caution is needed as metabolites may accumulate. It is advisable for dialysis patients to receive this medication after dialysis. In case of overdose, this medication can be removed through blood dialysis, so if an overdose is suspected, immediate medical staff notification is necessary. When using this medication as an injection, the solution should be visually inspected for abnormalities before administering, and the specified administration time and method should be followed, avoiding mixing with other medications for safety. Finally, during the course of treatment, any unusual reactions or changes in symptoms should be reported to medical staff immediately, and regular check-ups and monitoring are essential.

Side effects

Anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, headache, moniliasis, fungal infection, fever, dizziness, insomnia, taste disturbance, diarrhea, nausea, vomiting, abdominal pain, abdominal cramps, abdominal distension, constipation, dyspepsia, tongue discoloration, tooth discoloration, hypertension, vaginal moniliasis, rash, itching, abnormal blood test results, abnormal liver function tests, eosinophilia, upper respiratory tract infection, pharyngitis, cough, sepsis, trauma, localized pain, convulsions, gastrointestinal bleeding, oral moniliasis, hyperthrombocytosis, dyspnea, hypokalemia, sideroblastic anemia, anaphylaxis, lactic acidosis, peripheral neuropathy, vision loss, tongue discoloration, tooth discoloration, severe skin reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, hypersensitive vasculitis, rhabdomyolysis, septic shock, co-infections, multiple organ failure, infection, bacteremia, herpes zoster, edema, fungemia, decreased treatment response, candidemia, skin soft tissue infections, leukocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, left shift in leukocyte differential, hemoperitoneum, increased promyelocytes, worsening of acute myeloid leukemia, worsening of leukemia, worsening of acute lymphoblastic leukemia, worsening of multiple myeloma, progression of malignant lymphoma, intestinal ulcer, hematochezia, recurrence of esophageal cancer, gastric cancer, respiratory failure, pneumonia, pulmonary hemorrhage, hemoptysis, acute respiratory distress syndrome, pulmonary edema, pneumothorax, acute interstitial pneumonia, acute respiratory failure, worsening of empyema, apnea, exacerbation of hypoxemia, pulmonary infection, stridor, ventricular tachycardia, tachycardia, atrial fibrillation, myocardial infarction, worsening of heart failure, cardiac arrest, worsening of acute cardiopulmonary failure, arrhythmia, recurrence of myocardial infarction, hypotension, hyponatremia, hyperkalemia, worsening of hypocalcemia, sensory disturbance, anxiety, depression, meningitis, progression and worsening of subdural hemorrhage, intraventricular hemorrhage, cerebrovascular disorders, variceal hemorrhage, worsening of thrombotic microangiopathy, foot drop, advancing pyogenic arthritis, hyperthyroidism, exacerbation of graft-versus-host disease, neuropathy, pulmonary function failure, worsening of liver function failure, appendiceal cancer

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent air from entering, and it is recommended to store it at room temperature between 15 to 30 degrees Celsius. Proper storage conditions will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

A transparent injection solution ranging from colorless to yellow in an infusion bag.

Package unit

300 mL/pack X 1

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.