Medication info
Linezolid Tablet 600mg (Linezolid)

Linezolid Tablet 600mg (Linezolid)

Prescription medicationTabletOral
Ingredient · strength
Linezolid›600mg / 1 tablet
Manufacturer / importer
Youngjin Pharmaceutical Co., Ltd.
Appearance
White, convex, oval, film-coated tablet
Packaging
20 tablets/bottle
Approval status
Active

MFDS item code 201402365 · Approved 2014.05.23 · Insurance code 642403870

Summary

Main use
Treatment of pneumonia, skin and soft tissue infections, and vancomycin-resistant Enterococcus faecium infection
Who takes it
Adults · Children
Adult dose
Nosocomial pneumonia: Administer 600mg orally every 12 hours Community-acquired pneumonia (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours Complicated skin and soft tissue infections: Administer 600mg orally every 12 hours Uncomplicated skin and soft tissue infections: Adults: Administer 400mg orally every 12 hours Vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours Administer continuously for 10-14 days Administer continuously for 14-28 days Adult patients with infections caused by methicillin-resistant Staphylococcus aureus (MRSA) should receive 600 mg of this medication every 12 hours. If oral therapy is clinically indicated for a patient who began treatment with the injectable formulation, the patient may be switched at the physician's discretion. No dose adjustment is necessary in this case. The maximum duration of treatment with this medication is 28 days. The safety and efficacy of treatment beyond 28 days have not been established.
Child dose
Nosocomial pneumonia: Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Community-acquired pneumonia (including cases accompanied by bacteremia): Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Complicated skin and soft tissue infections: Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Uncomplicated skin and soft tissue infections: Under 5 years of age: Administer 10mg/kg orally every 8 hours Uncomplicated skin and soft tissue infections: 5-11 years of age: Administer 10mg/kg orally every 12 hours Uncomplicated skin and soft tissue infections: Adolescents (12-17 years of age): Administer 600mg orally every 12 hours Vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Adolescents and adults (12 years of age and older): Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), complicated skin and soft tissue infections, vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours * Newborns less than 7 days old: Most premature newborns less than 7 days old (pre-term neonates, at or before 34 weeks' gestation) have lower systemic clearance and higher AUC for this medication than term newborns and infants. These newborns should begin treatment with 10 mg/kg every 12 hours. For newborns whose clinical response is less than optimal, administration of 10 mg/kg every 8 hours may be considered. All newborn patients should receive 10 mg/kg every 8 hours through 7 days of age.

Ingredients

Manufacturer
Youngjin Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Hospital-acquired pneumonia
  • community-acquired pneumonia
  • bacteremia
  • skin and soft tissue infections
  • diabetic foot infections
View approved original text

This medication is used primarily for the treatment of significant hospital-acquired and community-acquired pneumonia. It is also effective for skin and soft tissue infections, including diabetic foot infections, both with and without complications. It is used to treat infections caused by vancomycin-resistant Enterococcus faecium and cases with bacteremia. This medication demonstrates activity against certain Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-susceptible Streptococcus pneumoniae, and Streptococcus pyogenes. However, appropriate treatment is required when infections due to Gram-negative bacteria are suspected. Overall, this medication is widely used for the treatment of various complicated bacterial infections.

How to take

Adult dose

Nosocomial pneumonia: Administer 600mg orally every 12 hours Community-acquired pneumonia (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours Complicated skin and soft tissue infections: Administer 600mg orally every 12 hours Uncomplicated skin and soft tissue infections: Adults: Administer 400mg orally every 12 hours Vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours Administer continuously for 10-14 days Administer continuously for 14-28 days Adult patients with infections caused by methicillin-resistant Staphylococcus aureus (MRSA) should receive 600 mg of this medication every 12 hours. If oral therapy is clinically indicated for a patient who began treatment with the injectable formulation, the patient may be switched at the physician's discretion. No dose adjustment is necessary in this case. The maximum duration of treatment with this medication is 28 days. The safety and efficacy of treatment beyond 28 days have not been established.

Child dose

Nosocomial pneumonia: Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Community-acquired pneumonia (including cases accompanied by bacteremia): Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Complicated skin and soft tissue infections: Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Uncomplicated skin and soft tissue infections: Under 5 years of age: Administer 10mg/kg orally every 8 hours Uncomplicated skin and soft tissue infections: 5-11 years of age: Administer 10mg/kg orally every 12 hours Uncomplicated skin and soft tissue infections: Adolescents (12-17 years of age): Administer 600mg orally every 12 hours Vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Children (newborns to 11 years of age)*: Administer 10mg/kg orally every 8 hours Adolescents and adults (12 years of age and older): Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia), complicated skin and soft tissue infections, vancomycin-resistant Enterococcus faecium infection (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours * Newborns less than 7 days old: Most premature newborns less than 7 days old (pre-term neonates, at or before 34 weeks' gestation) have lower systemic clearance and higher AUC for this medication than term newborns and infants. These newborns should begin treatment with 10 mg/kg every 12 hours. For newborns whose clinical response is less than optimal, administration of 10 mg/kg every 8 hours may be considered. All newborn patients should receive 10 mg/kg every 8 hours through 7 days of age.

Precautions

This medication can suppress bone marrow function, potentially leading to blood abnormalities such as anemia, leukopenia, and thrombocytopenia. Particularly, patients with significantly impaired kidney or liver function may experience a higher incidence of thrombocytopenia; therefore, patients taking this medication for more than two weeks or with a history of bone marrow suppression should regularly undergo blood tests. This medication can cause severe gastrointestinal symptoms known as antibiotic-associated pseudomembranous colitis. Therefore, if diarrhea persists after taking antibiotics, it is crucial to inform the hospital immediately and seek appropriate treatment if necessary. Due to uncertain effectiveness against Gram-negative infections, it is essential to check for Gram-negative infections when using this medication and consider other appropriate treatments if needed. When used concurrently with hypoglycemic agents or insulin, this medication may cause hypoglycemic symptoms; thus, diabetic patients should closely monitor changes in blood glucose levels and may require dosage adjustments if necessary. Patients with hypersensitivity, those taking certain MAO inhibitors, uncontrolled hypertension, hyperthyroidism, or specific mental illnesses should avoid using this medication. This medication should be used cautiously in patients with significantly impaired kidney or liver function, those weighing less than 40 kg, and patients with bone marrow suppression, as the risk of side effects increases with prolonged administration. Common side effects of this medication include diarrhea, headache, nausea, vomiting, abdominal pain, abdominal cramps, abdominal distension, constipation, indigestion, tongue discoloration, tooth discoloration, dizziness, insomnia, altered taste, fever, fungal infections, moniliasis, vaginal moniliasis, rashes, itching, abnormal blood test results, abnormal liver function tests, upper respiratory tract infections, pharyngitis, cough, pneumonia, pulmonary insufficiency, dental discoloration, hypokalemia, hyponatremia, hyperkalemia, worsening hypocalcemia, anxiety, and depression.

Side effects

Anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, diarrhea, headache, nausea, moniliasis, fungal infection, fever, dizziness, insomnia, taste alteration, vomiting, abdominal pain, abdominal cramps, abdominal distension, constipation, dyspepsia, tongue discoloration, teeth discoloration, hypertension, neutropenia, vaginal moniliasis, rash, itching, abnormal blood test results, abnormal liver function test results, frequent headaches, fever, trauma, localized pain, convulsions, loose stools, skin abnormalities, eosinophilia, upper respiratory tract infection, pharyngitis, cough, sepsis, edema, anaphylaxis, gastrointestinal bleeding, oral moniliasis, hyperthrombocytosis, dyspnea, hypokalemia, iron-deficiency anemia, lactic acidosis, peripheral neuropathy, vision loss, tongue hypopigmentation, severe skin abnormalities, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, hypersensitivity vasculitis, rhabdomyolysis, septic shock, secondary infections, multiple organ failure, infection, bacteremia, shingles, fungemia, reduced treatment response, candidemia, skin soft tissue infection, leukocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, left shift in leukocyte differential count, hemoperitoneum, increased marrow blast cells, deterioration of acute myeloid leukemia, exacerbation of leukemia, deterioration of acute lymphoblastic leukemia, exacerbation of multiple myeloma, progression of malignant lymphoma, intestinal ulcer, bloody stools, relapse of esophageal cancer, stomach 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 hypoxia, 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 deficit, anxiety, depression, meningitis, progression and exacerbation of subdural hemorrhage, intraventricular hemorrhage, cerebrovascular disorder, variceal hemorrhage, exacerbation of thrombotic microangiopathy, foot drop, progression of pyogenic arthritis, hyperthyroidism, worsening of graft-versus-host reaction, neuropathy, pulmonary function impairment, worsening of liver function impairment, appendiceal cancer

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, in a cool place between 15 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White, convex, oval, film-coated tablet

Package unit

20 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.