Medication info

Hanol Linezolid Injection 2 mg/mL

Prescription medicationOral · Intravenous injectionExpired
Ingredient · strength
Linezolid›2mg / 1mL
Manufacturer / importer
Hanol Biopharma Co., Ltd.
Appearance
A clear, colorless to yellow injection solution in a plastic bag
Packaging
300 mL/bag
Approval status
Expired

MFDS item code 201404029 · Approved 2014.08.28

This product's status changed to Expired on 2024.08.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of pneumonia, skin and soft tissue infections, and vancomycin-resistant Enterococcus faecium infections
Who uses it
Adults · Children
Adult dosage
Hospital-acquired pneumonia: Adolescents and adults (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 10 ∼ 14 consecutive days Community-acquired pneumonia (including cases with bacteremia): Adolescents and adults (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Adults: 400 mg orally every 12 hours; adolescents (12 ∼ 17 years): 600 mg 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): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Adolescents and adults (12 years of age or older): 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 medicine 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. At the physician's discretion, patients who started treatment with the injectable formulation may be switched to the tablets or syrup if clinically indicated.
Children's dosage
Hospital-acquired pneumonia: Children (newborns∼11 years): 10 mg per kg of body weight intravenously or orally every 8 hours, for 10 ∼ 14 consecutive days Community-acquired pneumonia (including cases with bacteremia): Children (newborns∼11 years): 10 mg per kg of body weight intravenously or orally every 8 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Children under 5 years: 10 mg per kg of body weight orally every 8 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Children 5 ∼ 11 years: 10 mg per kg of body weight orally every 12 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Adolescents (12 ∼ 17 years): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Children under 5 years: 10 mg per kg of body weight orally every 8 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Children 5 ∼ 11 years: 10 mg per kg of body weight orally every 12 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Adolescents (12 ∼ 17 years): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Children (newborns∼11 years): 10mg per kg of body weight intravenously or orally every 8 hours, for 14 ∼ 28 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Adolescents (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 14 ∼ 28 consecutive days Newborns less than 7 days old: Most preterm neonates less than 7 days old (gestational age 34 weeks or less) have lower systemic clearance and higher AUC for this medicine than full-term newborns and infants. Start these newborns at 10 mg per kg of body weight every 12 hours. Newborns less than 7 days old with a suboptimal clinical response: 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 through 7 days of age.

Ingredients

Manufacturer
Hanol Biopharma Co., Ltd.

Efficacy & effects

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

  • Hospital-acquired pneumonia
  • community-acquired pneumonia
  • bacteremia
  • skin and soft tissue infections
  • diabetic foot infections
  • skin and soft tissue infections without osteomyelitis
  • vancomycin-resistant Enterococcus faecium infections
View approved original text

This medication is primarily used to treat pneumonia caused by infections in hospitals and the community, particularly pneumonia accompanied by bacteremia. It is also effective for uncomplicated skin and soft tissue infections, including diabetic foot infections, and for complicated cases. It is used to treat infections caused by vancomycin-resistant Enterococcus faecium, especially when bacteremia is present. The strains that show activity against this medication include vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus, making it useful for antibiotic-resistant infections. There is no established clinical efficacy for gram-negative bacteria, so if a gram-negative infection is suspected, other appropriate treatments are necessary. This medication is used for treating the aforementioned bacterial infections.

Dosage and Administration

Adult dosage

Hospital-acquired pneumonia: Adolescents and adults (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 10 ∼ 14 consecutive days Community-acquired pneumonia (including cases with bacteremia): Adolescents and adults (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Adults: 400 mg orally every 12 hours; adolescents (12 ∼ 17 years): 600 mg 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): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Adolescents and adults (12 years of age or older): 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 medicine 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. At the physician's discretion, patients who started treatment with the injectable formulation may be switched to the tablets or syrup if clinically indicated.

Children's dosage

Hospital-acquired pneumonia: Children (newborns∼11 years): 10 mg per kg of body weight intravenously or orally every 8 hours, for 10 ∼ 14 consecutive days Community-acquired pneumonia (including cases with bacteremia): Children (newborns∼11 years): 10 mg per kg of body weight intravenously or orally every 8 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Children under 5 years: 10 mg per kg of body weight orally every 8 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Children 5 ∼ 11 years: 10 mg per kg of body weight orally every 12 hours, for 10 ∼ 14 consecutive days Complicated skin and soft tissue infections: Adolescents (12 ∼ 17 years): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Children under 5 years: 10 mg per kg of body weight orally every 8 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Children 5 ∼ 11 years: 10 mg per kg of body weight orally every 12 hours, for 10 ∼ 14 consecutive days Uncomplicated skin and soft tissue infections: Adolescents (12 ∼ 17 years): 600 mg orally every 12 hours, for 10 ∼ 14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Children (newborns∼11 years): 10mg per kg of body weight intravenously or orally every 8 hours, for 14 ∼ 28 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases with bacteremia): Adolescents (12 years of age or older): 600 mg intravenously or orally every 12 hours, for 14 ∼ 28 consecutive days Newborns less than 7 days old: Most preterm neonates less than 7 days old (gestational age 34 weeks or less) have lower systemic clearance and higher AUC for this medicine than full-term newborns and infants. Start these newborns at 10 mg per kg of body weight every 12 hours. Newborns less than 7 days old with a suboptimal clinical response: 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 through 7 days of age.

Precautions

This medication can cause bone marrow suppression, leading to a risk of decreased red blood cell, white blood cell, and platelet counts. In patients with severe impairment of renal or liver function, thrombocytopenia may occur more frequently, so regular blood tests should be conducted to monitor blood cell counts. Gastrointestinal symptoms such as diarrhea may occur during treatment, and there is a risk of serious colitis known as pseudomembranous colitis; therefore, if diarrhea persists, consult a physician immediately. This medication is ineffective against gram-negative infections, so proper alternative treatment is necessary if such an infection is suspected. Diabetic patients taking blood glucose-lowering medications may experience hypoglycemic symptoms, requiring careful monitoring of blood sugar levels. Patients with hypersensitivity to this medication or those taking certain MAO inhibitors, uncontrolled hypertension, or hyperthyroidism should not use this medication. Caution is also required for patients with a history of bone marrow suppression, severely impaired renal function, or who weigh less than 40 kg. Long-term use of this medication may lead to serious side effects, such as neuropathy, visual impairment, hyponatremia, and rhabdomyolysis; any abnormal symptoms should be reported to a physician immediately. This medication may interact with other drugs, so it is essential to inform the physician if taking other medications such as cold medications or antidepressants. Women who are pregnant or may become pregnant should carefully consider the risks to the fetus when using this medication, and it is recommended to discontinue breastfeeding while using this medication. Patients with impaired renal or liver function should also use caution, and for dialysis patients, it is advisable to administer the medication after dialysis. Care should be taken regarding the administration method and storage of this medication when given intravenously, and it should not be used if it contains insoluble substances or if the container is damaged.

Side effects

Anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, headache, moniliasis, fungal infection, fever, dizziness, insomnia, dysgeusia, 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, trauma, localized pain, eosinophilia, upper respiratory infection, pharyngitis, cough, sepsis, edema, anaphylaxis, convulsions, gastrointestinal bleeding, oral moniliasis, thrombocytosis, dyspnea, pneumonia, apnea, hypokalemia, sideroblastic anemia, lactic acidosis, peripheral neuropathy, vision loss, tongue depigmentation, bloody stools, vascular edema, hypersensitivity vasculitis, rhabdomyolysis, septic shock, superinfection, multiple organ failure, infection, bacteremia, shingles, fungal septicemia, decreased treatment response, candidemia, skin soft tissue infection, leukocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, leukocyte left shift, hemoperitoneum, post-myeloproliferative elevation, acute myeloid leukemia exacerbation, leukemia exacerbation, acute lymphoblastic leukemia exacerbation, multiple myeloma exacerbation, malignant lymphoma progression, intestinal ulcer, esophageal cancer recurrence, gastric cancer, respiratory failure, pulmonary hemorrhage, acute respiratory distress syndrome, pulmonary edema, pneumothorax, acute interstitial pneumonia, acute respiratory failure, empyema exacerbation, worsening of hypoxemia, pulmonary infection, stridor, ventricular tachycardia, tachycardia, atrial fibrillation, myocardial infarction, heart failure exacerbation, cardiac arrest, acute cardiopulmonary failure exacerbation, arrhythmia, recurrence of myocardial infarction, hypotension, hyponatremia, hyperkalemia, worsening of hypocalcemia, sensory impairment, anxiety, depression, meningitis, progression and exacerbation of subdural hemorrhage, intraventricular hemorrhage, cerebrovascular disorder, variceal hemorrhage, exacerbation of thrombotic microangiopathy, foot drop, progression of purulent 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 must be stored in a sealed container to prevent exposure to air and kept in a cool place between 15 and 30 degrees Celsius. Proper storage conditions help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

A clear, colorless to yellow injection solution in a plastic bag

Package unit

300 mL/bag

Same-ingredient medicines

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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.