Medication info
Cinezolid 600 mg Tablets (Linezolid)

Cinezolid 600 mg Tablets (Linezolid)

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

MFDS item code 201402416 · Approved 2014.05.28 · Insurance code 640006800

Summary

Main use
Treatment of vancomycin-resistant Enterococcus faecium infection, skin and soft tissue infections, and pneumonia
Who takes it
Adults · Children
Adult dose
Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: Adults: Administer 400mg orally every 12 hours for 10-14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Administer 600mg orally every 12 hours for 14-28 consecutive days Adult patients with infections caused by methicillin-resistant Staphylococcus aureus (MRSA) should receive this drug at a dose of 600 mg every 12 hours. If oral therapy is clinically indicated for a patient who started treatment with the injectable formulation, the patient may be switched at the physician’s discretion. No dose adjustment is required in this case. The maximum duration of treatment with this drug is 28 days. Safety and efficacy for treatment exceeding 28 days have not been established.
Child dose
Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia): Children (neonates to 11 years): Administer 10mg per kg of body weight orally every 8 hours for 10-14 consecutive days Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia): Adolescents and adults (12 years and older): Administer 600mg orally every 12 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: Under 5 years: Administer 10mg per kg of body weight orally every 8 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: 5-11 years: Administer 10mg per kg of body weight orally every 12 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: Adolescents (12-17 years): Administer 600mg orally every 12 hours for 10-14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Children (neonates to 11 years): Administer 10mg per kg of body weight orally every 8 hours for 14-28 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Adolescents and adults (12 years and older): Administer 600mg orally every 12 hours for 14-28 consecutive days 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 with this drug than term neonates and infants. These neonates should be started on a dose of 10 mg per kg of body weight every 12 hours. For neonates whose clinical response is less than optimal, administration of 10 mg per kg every 8 hours may be considered. All neonatal patients should receive 10 mg per kg of body weight every 8 hours through 7 days of age.

Ingredients

Manufacturer
HK Inno.N Co., Ltd.

Efficacy & effects

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

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

This medication is effective against infections caused by certain gram-positive bacteria, particularly vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus. It is used to treat nosocomial pneumonia, community-acquired pneumonia, and complicated skin and soft tissue infections. It may also be applicable for diabetic foot infections without accompanying osteomyelitis. It is helpful for infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. The clinical efficacy against gram-negative bacterial infections has not been established, thus additional treatment may be necessary if gram-negative infections are suspected. Using this medication can improve the patient's condition in the treatment of these infections.

How to take

Adult dose

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

Child dose

Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia): Children (neonates to 11 years): Administer 10mg per kg of body weight orally every 8 hours for 10-14 consecutive days Nosocomial pneumonia, community-acquired pneumonia (including cases accompanied by bacteremia): Adolescents and adults (12 years and older): Administer 600mg orally every 12 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: Under 5 years: Administer 10mg per kg of body weight orally every 8 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: 5-11 years: Administer 10mg per kg of body weight orally every 12 hours for 10-14 consecutive days Complicated skin and soft tissue infections, uncomplicated skin and soft tissue infections: Adolescents (12-17 years): Administer 600mg orally every 12 hours for 10-14 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Children (neonates to 11 years): Administer 10mg per kg of body weight orally every 8 hours for 14-28 consecutive days Vancomycin-resistant Enterococcus faecium infections (including cases accompanied by bacteremia): Adolescents and adults (12 years and older): Administer 600mg orally every 12 hours for 14-28 consecutive days 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 with this drug than term neonates and infants. These neonates should be started on a dose of 10 mg per kg of body weight every 12 hours. For neonates whose clinical response is less than optimal, administration of 10 mg per kg every 8 hours may be considered. All neonatal 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 anemia or reduction in blood cell counts. Particularly in patients with severely impaired kidney or liver function, thrombocytopenia may occur more frequently, hence regular blood tests are required. If symptoms of diarrhea appear during this medication, there may be a possibility of severe intestinal conditions such as pseudomembranous colitis, so it is necessary to consult a doctor immediately. Antibiotic use can alter normal intestinal flora, increasing the risk of infections. This medication is ineffective against certain gram-negative bacterial infections; thus, if such infections are suspected, appropriate alternative therapy should be started. Additionally, it should not be used for treating bloodstream infections via central venous catheters. Diabetic patients taking this medication in conjunction with insulin or hypoglycemic agents should closely monitor their blood glucose levels for risk of hypoglycemia, and dosage adjustments may be necessary if needed. This medication may cause serious side effects, such as increased blood pressure or serotonin syndrome, if taken with certain drugs; therefore, patients should inform their doctor of all medications they are currently taking. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of taking this medication during pregnancy, and breastfeeding should be suspended if nursing. Pediatric patients may require dosage adjustments based on age, while elderly patients can use it without special dosage adjustments. Caution is required when administering this medication to patients with severely impaired kidney or liver function, and it is advisable to administer it after dialysis in patients undergoing dialysis. In case of overdose, immediate medical attention is required, and blood dialysis can be used to remove the drug. During the administration of this medication, for injectable forms, ensure that there are no impurities before administration and maintain an appropriate infusion rate, and do not mix it with other medications. If any unusual symptoms, vision changes, or neurological symptoms occur during use, immediate consultation with healthcare providers is necessary, as the risk of these side effects increases with prolonged drug administration. This medication can lead to various serious side effects; hence, it is crucial to review the patient's medical history and current medications before administration and to undergo regular check-ups and monitoring.

Side effects

Anemia, leukopenia, pancytopenia, thrombocytopenia, pseudomembranous colitis, hypoglycemia, diarrhea, headache, nausea, moniliasis, fungal infection, fever, dizziness, insomnia, altered taste, vomiting, abdominal pain, abdominal cramps, abdominal bloating, constipation, dyspepsia, tongue discoloration, tooth discoloration, hypertension, neutropenia, vaginal moniliasis, rash, itching, abnormal blood test results, abnormal liver function test results, trauma, localized pain, loose stools, skin abnormalities, eosinophilia, upper respiratory tract infection, pharyngitis, cough, sepsis, septic shock, superinfection, multiple organ failure, infection, bacteremia, herpes zoster, death, fungemia, decreased treatment response, candidemia, skin and soft tissue infection, leukocytosis, thrombocytosis, disseminated intravascular coagulation, increased INR, increased aPTT, left shift of white blood cell differential, hemoperitoneum, elevated bone marrow granulocytes, exacerbation of acute myeloid leukemia, leukemia progression, exacerbation of acute lymphoblastic leukemia, exacerbation of multiple myeloma, progression of malignant lymphoma, gastrointestinal bleeding, exacerbation of pseudomembranous colitis, intestinal ulcer, tongue depigmentation, 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, exacerbation of empyema, 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, hepatic failure, hyperbilirubinemia, increased serum bilirubin, progression of hepatic encephalopathy, exacerbation of liver tumors, hepatorenal syndrome, progression of bile duct cancer, exacerbation of cholangitis, cholecystitis, exacerbation of cholecystitis with pus, choledochitis, exacerbation of colorectal cancer liver metastasis, jaundice, ventricular tachycardia, tachycardia, atrial fibrillation, myocardial infarction, exacerbation of heart failure, cardiac arrest, exacerbation of acute cardiopulmonary failure, arrhythmia, recurrence of myocardial infarction, hypotension, hyponatremia, hyperkalemia, hypokalemia, electrolyte disorder, worsening hypocalcemia, seizures, sensory impairment, anxiety, depression, meningitis, progression and exacerbation of subdural hemorrhage, intraventricular hemorrhage, cerebrovascular disorders, variceal bleeding, exacerbation of thrombotic microangiopathy, foot drop, progression of purulent arthritis, hyperthyroidism, exacerbation of graft-versus-host disease, lactic acidosis, anaphylaxis, optic neuropathy leading to vision loss, severe skin abnormalities, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, hypersensitivity vasculitis, rhabdomyolysis, 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 medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to keep it in a cool place between 15 to 30 degrees Celsius.

Appearance and packaging

Appearance

White 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.