Medication info

Cienzolid Injection 2mg/mL (Linezolid)

Prescription medication
Ingredient · strength
Linezolid›2mg / 1mL
Manufacturer / importer
HK inno.N Co., Ltd.
Appearance
A transparent injection solution that is colorless or yellow in a plastic bag
Packaging
300mL
Approval status
Active

MFDS item code 201402275 · Approved 2014.05.16 · Insurance code 640006621

Summary

Main use
Treatment of pneumonia, skin and soft tissue infections, and vancomycin-resistant enterococcal infections
Who uses it
Adults · Children
Adult dosage
Adults: Administer 400 mg orally every 12 hours. Adults with infections caused by MRSA should receive 600 mg of this drug every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dosage adjustment is necessary when switching from intravenous to oral administration. Patients who began treatment with this drug as an injection may be switched to the tablets or syrup at the physician’s discretion if clinically indicated.
Children's dosage
Pediatric patients (newborns to 11 years) with nosocomial pneumonia: Administer 10 mg/kg intravenously or orally every 8 hours. Pediatric patients (newborns to 11 years) with community-acquired pneumonia (including cases accompanied by bacteremia): Administer 10 mg/kg intravenously or orally every 8 hours. Children under 5 years: Administer 10 mg/kg orally every 8 hours. Children 5 ∼ 11 years: Administer 10 mg/kg orally every 12 hours. Adolescents (12 ∼ 17 years): Administer 600 mg orally every 12 hours. Pediatric patients (newborns to 11 years) with vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Administer 10 mg/kg intravenously or orally every 8 hours. Adolescents and adults (12 years and older) with nosocomial pneumonia: Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with community-acquired pneumonia (including cases accompanied by bacteremia): Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with complicated skin and soft tissue infections or uncomplicated skin and soft tissue infections: Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Administer 600 mg intravenously or orally every 12 hours. Neonates under 7 days old: Most preterm neonates born at up to 34 weeks’ gestation who are under 7 days old have lower systemic clearance and higher AUC than term neonates and infants. These neonates should be started on 10 mg/kg every 12 hours. Neonates under 7 days old: For neonates whose clinical response falls short of optimal efficacy, administration of 10 mg/kg every 8 hours may be considered. All neonatal patients should receive 10 mg/kg every 8 hours until 7 days of age.

Ingredients

Manufacturer
HK inno.N Co., Ltd.

Efficacy & effects

Treatment of pneumonia, skin and soft tissue infections, and vancomycin-resistant enterococcal 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 for hospital-acquired pneumonia and community-acquired pneumonia, as well as uncomplicated skin and soft tissue infections. It is especially effective for skin infections with complications such as diabetic foot infections, provided there is no accompanying osteomyelitis. Additionally, it is used to treat infections caused by vancomycin-resistant Enterococcus faecium, being effective even in cases where bloodstream infections are present. This drug has activity against a variety of gram-positive bacteria, assisting in the treatment of several infections. However, if there is confirmation or suspicion of infection due to gram-negative bacteria, separate appropriate treatment is necessary. Therefore, this drug is used for the treatment of hospital-acquired and community-acquired pneumonia, skin and soft tissue infections, and infections caused by vancomycin-resistant Enterococcus faecium.

Dosage and Administration

Adult dosage

Adults: Administer 400 mg orally every 12 hours. Adults with infections caused by MRSA should receive 600 mg of this drug every 12 hours. For intravenous administration, infuse over 30 ∼ 120 minutes. No dosage adjustment is necessary when switching from intravenous to oral administration. Patients who began treatment with this drug as an injection may be switched to the tablets or syrup at the physician’s discretion if clinically indicated.

Children's dosage

Pediatric patients (newborns to 11 years) with nosocomial pneumonia: Administer 10 mg/kg intravenously or orally every 8 hours. Pediatric patients (newborns to 11 years) with community-acquired pneumonia (including cases accompanied by bacteremia): Administer 10 mg/kg intravenously or orally every 8 hours. Children under 5 years: Administer 10 mg/kg orally every 8 hours. Children 5 ∼ 11 years: Administer 10 mg/kg orally every 12 hours. Adolescents (12 ∼ 17 years): Administer 600 mg orally every 12 hours. Pediatric patients (newborns to 11 years) with vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Administer 10 mg/kg intravenously or orally every 8 hours. Adolescents and adults (12 years and older) with nosocomial pneumonia: Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with community-acquired pneumonia (including cases accompanied by bacteremia): Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with complicated skin and soft tissue infections or uncomplicated skin and soft tissue infections: Administer 600 mg intravenously or orally every 12 hours. Adolescents and adults (12 years and older) with vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Administer 600 mg intravenously or orally every 12 hours. Neonates under 7 days old: Most preterm neonates born at up to 34 weeks’ gestation who are under 7 days old have lower systemic clearance and higher AUC than term neonates and infants. These neonates should be started on 10 mg/kg every 12 hours. Neonates under 7 days old: For neonates whose clinical response falls short of optimal efficacy, administration of 10 mg/kg every 8 hours may be considered. All neonatal patients should receive 10 mg/kg every 8 hours until 7 days of age.

Precautions

This medication can suppress the bone marrow that produces blood cells, potentially leading to issues such as anemia, leukopenia, or thrombocytopenia. Particularly, thrombocytopenia may occur more frequently in patients with severely impaired kidney or liver function, so regular blood tests are required if used for more than two weeks or in patients with a history of bone marrow suppression. Using this drug may lead to an inflammatory condition in the gastrointestinal tract called pseudomembranous colitis; hence, if diarrhea persists after administration, the healthcare provider should be notified immediately. Furthermore, this drug is only effective against certain bacteria, and if infection with gram-negative bacteria is suspected or confirmed, alternative appropriate treatment is necessary. Diabetic patients using this medication in conjunction with blood glucose-lowering agents may experience hypoglycemic symptoms, so blood glucose levels should be monitored closely, and dose adjustments may be necessary. Caution is required when this drug is used with specific medications, as there may be dangerous interactions; thus, patients must inform their healthcare provider of all medications they are taking. Particularly, combinations with MAO inhibitors, sympathomimetics, and serotonergic drugs require careful consideration. Women who are pregnant or breastfeeding should consult their doctor before using this medication as it may affect the fetus or newborn, and discontinuation of breastfeeding is recommended during the drug administration period. Dosage and duration should be adjusted for children, the elderly, and patients with impaired kidney or liver function, and regular examination is necessary as prolonged use may result in side effects such as nerve damage or changes in vision. In case of overdose, immediate hospital treatment is necessary, and the speed and method of intravenous administration must be strictly followed. Finally, this medication should be kept out of the reach of children and not transferred to other containers.

Side effects

Anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, headache, moniliasis, fungal infection, fever, dizziness, insomnia, altered taste, 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, frequent headaches, fever, trauma, localized pain, occasional dizziness, nausea, vomiting, abdominal pain, loose stools, rash, skin abnormalities, itching in non-applicable areas, eosinophilia, upper respiratory tract infection, pharyngitis, cough, sepsis, convulsions, gastrointestinal bleeding, oral moniliasis, thrombocytosis, dyspnea, hypokalemia, pancytopenia, iron deficiency anemia, anaphylaxis, lactic acidosis, peripheral neuropathy, vision loss, tongue depigmentation, severe skin abnormalities, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, hypersensitivity vasculitis, rhabdomyolysis, septic shock, co-infection, multiple organ failure, infection, bacteremia, herpes zoster, death, fungal bloodstream infection, reduced therapeutic response, candidemia, skin soft tissue infection, leukocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, left shift in leukocyte percentage, hemoperitoneum, increases in bone marrow cellularity, acute myeloid leukemia exacerbation, leukemia exacerbation, acute lymphoblastic leukemia exacerbation, multiple myeloma exacerbation, malignant lymphoma progression, gastrointestinal bleeding, intestinal ulcers, bloody stools, 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, apnea, worsening hypoxemia, lung infection, wheezing, dyspnea, increased non-protein nitrogen, acute renal failure, urinary tract infection, increased blood urea nitrogen, renal failure, pyuria, hematuria, liver function failure, hyperbilirubinemia, increased serum bilirubin, progression of hepatic encephalopathy, deterioration of hepatic neoplasm, hepatorenal syndrome, cholangiocarcinoma progression, cholangitis exacerbation, cholecystitis, exacerbation of cholecystitis, cholangitis, deterioration of colorectal cancer liver metastasis, jaundice, ventricular tachycardia, tachycardia, atrial fibrillation, myocardial infarction, heart failure exacerbation, cardiac arrest, exacerbation of acute heart-lung failure, arrhythmia, recurrence of myocardial infarction, hypotension, hyponatremia, hyperkalemia, hypokalemia, electrolyte imbalance, worsening hypocalcemia, sensory deficit, anxiety, depression, meningitis, progression and exacerbation of subdural hemorrhage, intraventricular hemorrhage, cerebrovascular disorders, variceal hemorrhage, worsening thrombotic microangiopathy, foot drop, progression of pyogenic arthritis, hyperthyroidism, exacerbation of graft-versus-host disease, neuropathy, pulmonary function failure, worsening liver function failure, optic neuropathy, appendiceal cancer

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, ideally at room temperature between 15 and 30 degrees Celsius. Proper storage maintains the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

A transparent injection solution that is colorless or yellow in a plastic bag

Package unit

300mL

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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.