Medication info

Medica Vancomycin Hydrochloride Injection 500 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Vancomycin Hydrochloride›Strength being verified
Manufacturer / importer
(주)메디카코리아
Appearance
A colorless transparent vial filled with a white to light yellowish brown freeze-dried powder injection
Packaging
10 mL x 10 vials
Approval status
Approval withdrawn

MFDS item code 201802051 · Notified 2018.05.15

This product's status changed to Approval withdrawn on 2023.05.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of severe infections (such as endocarditis, pneumonia, etc.) and antibiotic-associated colitis
Who uses it
Adults · Children
Adult dosage
Administer 500 mg (units) intravenously every 6 hours or 1 g (units) intravenously every 12 hours. For oral administration, 500 to 2000 mg should be divided into 3 to 4 doses over 7 to 10 days. The total daily dose should not exceed 2 g.
Children's dosage
Administer 10 mg (units) per kg of body weight intravenously every 6 hours. Infants receive 10 to 15 mg (units) per kg of body weight intravenously every 12 hours. For infants and newborns, an initial dosage of 15 mg per kg of body weight is recommended.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Treatment of severe infections (such as endocarditis, pneumonia, etc.) and antibiotic-associated colitis

  • Endocarditis
  • osteomyelitis
  • arthritis
  • peritonitis
  • meningitis
  • burns
  • surgical wounds
  • pneumonia
  • sepsis
  • lung abscess
  • empyema
  • severe infections
View approved original text

This medication is used to treat various infections caused by streptococci, staphylococci, Clostridium difficile, and diphtheroid bacteria. It is effective for a variety of serious infections, including endocarditis, osteomyelitis, arthritis, peritonitis, meningitis, and secondary infections at burn or surgical sites. It is also administered for severe lung-related infections such as pneumonia, sepsis, and lung abscess. Particularly, it can be used for severe infections that are difficult to treat with penicillin and cephalosporin antibiotics, and it is also suitable for the oral treatment of antibiotic-associated colitis due to Clostridium difficile. This drug has a broad efficacy against various bacteria and effectively improves symptoms of infection in patients.

Dosage and Administration

Adult dosage

Administer 500 mg (units) intravenously every 6 hours or 1 g (units) intravenously every 12 hours. For oral administration, 500 to 2000 mg should be divided into 3 to 4 doses over 7 to 10 days. The total daily dose should not exceed 2 g.

Children's dosage

Administer 10 mg (units) per kg of body weight intravenously every 6 hours. Infants receive 10 to 15 mg (units) per kg of body weight intravenously every 12 hours. For infants and newborns, an initial dosage of 15 mg per kg of body weight is recommended.

Precautions

This medication should not be used in specific patients. For example, it should not be given to patients who have previously experienced shock from this drug or have had allergic reactions to this drug, peptide antibiotics, or aminoglycoside antibiotics. Additionally, caution should be taken in certain patient populations. Patients with hearing loss or a history of hearing loss, patients with kidney dysfunction, those with poor liver function, elderly patients, premature infants, or newborns, and those with damage to the vestibular or auditory systems require special attention when using this drug. This drug can rarely affect the central nervous system, leading to severe allergic reactions such as shock or anaphylaxis, thus symptoms should be closely monitored. Gastrointestinal side effects may include diarrhea, nausea, vomiting, and abdominal pain. Hematological effects may show reductions in red blood cells, white blood cells, and platelets, or increased eosinophils, while central nervous system effects may produce dizziness, tinnitus, and hearing impairment, so regular hearing tests are advisable. Liver dysfunction and decreased kidney function may also occur, so regular liver and kidney function tests are necessary, and the skin may develop rashes, vesicular dermatitis, or in severe cases, serious skin reactions such as Stevens-Johnson syndrome. This drug can cause hypersensitivity reactions, and if symptoms like rashes or breathing difficulties occur, immediate treatment is needed. Rapid infusion can lead to Red Man Syndrome, characterized by skin redness, pain, and muscle spasms, so slow infusion is important. Long-term use of this drug can lead to antibiotic-resistant bacteria, so it is recommended to administer it only for the necessary duration based on susceptibility testing. Furthermore, the use of this drug alongside other nephrotoxic or neurotoxic medications may increase side effects, so it should be used carefully under the direction of a physician. Pregnant or breastfeeding women should use this drug only when absolutely necessary as its safety has not been fully established, and breastfeeding should be discontinued during treatment. Young patients, especially premature infants and newborns, require careful dosing as their kidney function is not fully developed, which can lead to elevated blood levels. Elderly patients are more likely to have impaired kidney function, so kidney function tests should be conducted before and during treatment, and dose adjustments made as necessary. In case of overdose, serious side effects such as acute kidney failure or hearing loss may occur, requiring immediate treatment, and this drug is not readily removed by dialysis, necessitating specialized treatment. Finally, this drug must be administered intravenously; intramuscular injection or careless administration can cause tissue damage and pain. The injection solution should be diluted and infused slowly, and when mixing with other medications, chemical stability should be considered.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of mouth/eye mucous membranes, asthma attack, breathing abnormalities with cough and fever, yellowing of skin or eyes (jaundice), generalized lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, generalized severe swelling, blood pressure changes

Mild side effects

Loose stools, diarrhea, nausea, vomiting, abdominal pain, decreased red blood cells, decreased white blood cells, decreased platelets, increased eosinophils, dizziness, tinnitus, hearing loss, elevated bilirubin, AST, ALT, ALP, elevated LDH, γ-GTP, LAP, elevated BUN, creatinine, fever, vascular pain, phlebitis, nausea, chills, vascular inflammation, purpuric rash, maculopapular rash, vesicular rash, injection site rash, conductive hearing loss (clinical manifestation)

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. The appropriate storage temperature is room temperature between 1 degree Celsius and 30 degrees Celsius. This storage method will help maintain the efficacy of the medication.

Appearance and packaging

Appearance

A colorless transparent vial filled with a white to light yellowish brown freeze-dried powder injection

Package unit

10 mL x 10 vials

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.