Medication info

JW Linezolid Injection

Prescription medicationInjectionsOral · Intravenous injectionExpired
Ingredient · strength
Linezolid›2mg / 1mL
Manufacturer / importer
JW Pharmaceutical Co., Ltd.
Appearance
An injection in a colorless to yellow transparent solution filled in a colorless transparent plastic bag.
Packaging
300mL/bag
Approval status
Expired

MFDS item code 201404222 · Approved 2014.09.15

This product's status changed to Expired on 2024.09.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of vancomycin-resistant Enterococcus faecium infection, pneumonia, and skin and soft tissue infections
Who uses it
Adults · Children
Adult dosage
Hospital-acquired pneumonia, community-acquired pneumonia (including cases with bacteremia), complicated skin and skin structure infections, uncomplicated skin and skin structure infections Adolescents and adults (aged 12 years and older): 600 mg intravenously or orally every 12 hours Administer continuously for 10 ∼ 14 days Complicated skin and skin structure infections, uncomplicated skin and skin structure infections Adults: 400 mg orally every 12 hours Adolescents (aged 12 ∼ 17 years): 600 mg orally every 12 hours Administer continuously for 10 ∼ 14 days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia) Adolescents and adults (aged 12 years and older): 600 mg intravenously or orally every 12 hours Administer continuously for 14 ∼ 28 days Adult patients with infections caused by MRSA should receive this medicine at a dose of 600 mg every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dosage adjustment is necessary when switching from intravenous to oral administration. If clinically indicated, patients who began treatment with this medicine as an injection may be switched to this medicine as tablets or syrup at the physician's discretion.
Children's dosage
Hospital-acquired pneumonia, community-acquired pneumonia (including cases with bacteremia) Pediatric patients (newborns to 11 years): 10 mg/kg intravenously or orally every 8 hours Complicated skin and skin structure infections, uncomplicated skin and skin structure infections Under 5 years: 10 mg/kg orally every 8 hours 5 ∼ 11 years: 10 mg/kg orally every 12 hours Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia) Pediatric patients (newborns to 11 years): 10 mg/kg intravenously or orally every 8 hours Neonates younger than 7 days: Most preterm neonates younger than 7 days (born at 34 weeks' gestation or earlier) have lower systemic clearance and higher AUC for this medicine than full-term neonates and infants. These neonates should initially be given 10 mg/kg every 12 hours. For neonates whose clinical response is less than optimal, administration of 10 mg/kg every 8 hours may be considered. All neonatal patients should receive 10 mg/kg every 8 hours through 7 days of age.

Ingredients

Manufacturer
JW Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of vancomycin-resistant Enterococcus faecium infection, 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 without osteomyelitis
  • infections caused by vancomycin-resistant Enterococcus faecium
View approved original text

This medication is primarily used for the treatment of hospital-acquired pneumonia, community-acquired pneumonia (including bacteremia), and skin and soft tissue infections. It is particularly effective in cases of skin infections without complications and osteomyelitis in patients with diabetic foot infections. It can also be used for infections caused by Enterococcus faecium resistant to vancomycin. It is effective against Gram-positive bacterial infections, though clinical efficacy for some Gram-negative bacteria has not been established, so additional treatment may be necessary if Gram-negative infections are suspected. Due to these characteristics, it is effectively used in treating various bacterial infections.

Dosage and Administration

Adult dosage

Hospital-acquired pneumonia, community-acquired pneumonia (including cases with bacteremia), complicated skin and skin structure infections, uncomplicated skin and skin structure infections Adolescents and adults (aged 12 years and older): 600 mg intravenously or orally every 12 hours Administer continuously for 10 ∼ 14 days Complicated skin and skin structure infections, uncomplicated skin and skin structure infections Adults: 400 mg orally every 12 hours Adolescents (aged 12 ∼ 17 years): 600 mg orally every 12 hours Administer continuously for 10 ∼ 14 days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia) Adolescents and adults (aged 12 years and older): 600 mg intravenously or orally every 12 hours Administer continuously for 14 ∼ 28 days Adult patients with infections caused by MRSA should receive this medicine at a dose of 600 mg every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dosage adjustment is necessary when switching from intravenous to oral administration. If clinically indicated, patients who began treatment with this medicine as an injection may be switched to this medicine as tablets or syrup at the physician's discretion.

Children's dosage

Hospital-acquired pneumonia, community-acquired pneumonia (including cases with bacteremia) Pediatric patients (newborns to 11 years): 10 mg/kg intravenously or orally every 8 hours Complicated skin and skin structure infections, uncomplicated skin and skin structure infections Under 5 years: 10 mg/kg orally every 8 hours 5 ∼ 11 years: 10 mg/kg orally every 12 hours Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia) Pediatric patients (newborns to 11 years): 10 mg/kg intravenously or orally every 8 hours Neonates younger than 7 days: Most preterm neonates younger than 7 days (born at 34 weeks' gestation or earlier) have lower systemic clearance and higher AUC for this medicine than full-term neonates and infants. These neonates should initially be given 10 mg/kg every 12 hours. For neonates whose clinical response is less than optimal, administration of 10 mg/kg every 8 hours may be considered. All neonatal patients should receive 10 mg/kg every 8 hours through 7 days of age.

Precautions

This medication may suppress bone marrow, which can lead to anemia or a decrease in blood cell counts; therefore, patients receiving this drug for more than 2 weeks, or those with a history of bone marrow suppression, or severe renal or hepatic impairment should regularly undergo blood tests. If diarrhea occurs during treatment, it may indicate a serious bowel condition such as pseudomembranous colitis, and immediate notification to a healthcare professional is required. As this medication is not definitively effective for Gram-negative bacterial infections, alternative appropriate treatment may be necessary if Gram-negative infections are suspected. Diabetic patients taking this medication along with insulin or antidiabetic agents should closely monitor changes in blood sugar due to the risk of hypoglycemia. Patients with allergies to this medication or its components, those who have taken MAO inhibitors within the last two weeks, those with uncontrolled hypertension, or specific psychiatric conditions should not use it. Precaution should be taken for patients with a history of bone marrow suppression or those expected to be on long-term treatment, patients with severe renal impairment, and those weighing less than 40 kg. Common side effects include diarrhea, headache, and nausea, while rare but serious side effects may include severe blood disorders, neuropathy, and skin reactions. Pregnant or breastfeeding women should use it only when absolutely necessary, considering the potential impacts on the fetus and newborn, and breastfeeding is recommended to be suspended during the treatment period. This medication may interact with other drugs that can elevate blood pressure, so patients should inform their healthcare provider about any medications they are taking. When administering, ensure the injection solution is normal, and infuse slowly over a specified period, being careful not to mix with or continuously infuse other drugs. Long-term use of this medication may lead to neuropathy or vision problems, and if changes in vision occur, an ophthalmology consultation should be sought immediately. Patients receiving this medication may show signs of hyponatremia, rhabdomyolysis, or other unusual symptoms, so they should immediately consult their healthcare provider if such symptoms arise.

Side effects

Bone marrow suppression, anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, headache, moniliasis, fungal infection, fever, dizziness, insomnia, taste distortion, diarrhea, nausea, vomiting, abdominal pain, abdominal cramping, abdominal distension, constipation, dyspepsia, tongue discoloration, tooth discoloration, hypertension, vaginal moniliasis, rash, itching, abnormal blood test results, abnormal liver function test results, thrombocytopenia, hemoglobin decrease, leukopenia, neutropenia, frequent headaches, fever, trauma, localized pain, occasional dizziness, frequent diarrhea, occasional nausea, vomiting, abdominal pain, loose stools, occasional rashes, skin abnormalities, itching in non-applicable areas, occasional eosinophilia, occasional upper respiratory infection, pharyngitis, cough, frequent fever, sepsis, occasional headaches, trauma, edema, localized pain, injection site or vascular catheter site reactions, anaphylaxis, occasional convulsions, frequent diarrhea, nausea, occasional vomiting, abdominal pain, gastrointestinal bleeding, loose stools, oral moniliasis, frequent rashes, occasional skin abnormalities, frequent anemia, occasional thrombocytopenia, thrombocytosis, eosinophilia, occasional upper respiratory infection, dyspnea, pharyngitis, pneumonia, cough, apnea, occasional hypokalemia, pancytopenia, iron-deficiency anemia, anaphylaxis, lactic acidosis, convulsions, peripheral neuropathy, vision loss, tongue discoloration, tooth discoloration, severe skin abnormalities, toxic epidermal necrolysis, Stevens-Johnson syndrome, vesicular skin disease, angioedema, hypersensitivity vasculitis, rhabdomyolysis, septic shock, superinfection, multiple organ failure, infection, bacteremia, herpes zoster, death, fungal bacteremia, reduced treatment response, candidemia, skin soft tissue infection, leukocytosis, thrombocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, left shift leukocytosis, hemoperitoneum, elevated bone marrow progenitor cells, acute myeloid leukemia exacerbation, leukemia exacerbation, acute lymphoblastic leukemia exacerbation, multiple myeloma exacerbation, malignant lymphoma progression, gastrointestinal bleeding, pseudomembranous colitis exacerbation, intestinal ulcer, tongue depigmentation, hematochezia, esophageal cancer recurrence, stomach cancer, respiratory failure, pneumonia, pulmonary hemorrhage, hemoptysis, acute respiratory distress syndrome, pulmonary edema, pneumothorax, acute interstitial pneumonia, acute respiratory failure, empyema exacerbation, hypoxemia exacerbation, pulmonary infection, stridor, dyspnea, non-protein nitrogen increase, acute renal failure, urinary tract infection, increased blood urea nitrogen, renal failure, pyuria, hematuria, hepatic failure, hyperbilirubinemia, increased serum bilirubin, progression of hepatic encephalopathy, exacerbation of liver neoplasm, hepatorenal syndrome, progression of bile duct cancer, exacerbation of cholangitis, cholecystitis, exacerbation of cholecystitis, cholangitis, worsening of colorectal cancer metastasis to the liver, jaundice, ventricular tachycardia, tachycardia, atrial fibrillation, myocardial infarction, heart failure exacerbation, cardiac arrest, acute cardiopulmonary failure exacerbation, arrhythmia, recurrence of myocardial infarction, hypotension, hyponatremia, hyperkalemia, hypokalemia, electrolyte imbalance, worsening of hypocalcemia, convulsions, insomnia, sensory loss, anxiety, depression, meningitis, progression and exacerbation of subdural hematoma, intraventricular hemorrhage, cerebrovascular disorders, variceal bleeding, exacerbation of thrombotic microangiopathy, foot drop, progression of pyogenic arthritis, hyperthyroidism, acute graft-versus-host disease exacerbation, neuropathy, pulmonary function failure, exacerbation of hepatic dysfunction, optic neuropathy, 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 ingress, and the recommended storage temperature is between 15 to 30 degrees Celsius in a cool place. Storing it this way helps maintain the effectiveness of the drug and prevents deterioration.

Appearance and packaging

Appearance

An injection in a colorless to yellow transparent solution filled in a colorless transparent plastic bag.

Package unit

300mL/bag

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.