Medication info

Medica Vancomycin Hydrochloride Injection 1 Gram

Prescription medicationApproval withdrawn
Ingredient · strength
Vancomycin Hydrochloride›Strength being verified
Manufacturer / importer
(주)메디카코리아
Appearance
A colorless and transparent vial containing white or pale yellowish freeze-dried powder for injection
Packaging
20mL x 10 vials
Approval status
Approval withdrawn

MFDS item code 201802052 · 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This product's status changed to Approval withdrawn on 2023.05.02.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 (endocarditis, osteomyelitis, etc.) and antibiotic-associated colitis
Who uses it
Adults · Children
Adult dosage
Adults: 500mg (potency) intravenously every 6 hours or 1g (potency) every 12 hours. For oral administration: 500-2000mg daily, divided into 3-4 doses for 7-10 days. The total daily dose should not exceed 2g.
Children's dosage
Children: 10mg/kg (potency) intravenously every 6 hours. Infants: 10-15mg/kg (potency) intravenously every 12 hours. Infants, newborns: 10-15mg/kg

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Treatment of severe infections (endocarditis, osteomyelitis, etc.) and antibiotic-associated colitis

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

This medication is effective against various bacteria including Streptococcus, Staphylococcus, Clostridium difficile, and diphtheroids. It is used for serious infections such as endocarditis, osteomyelitis, arthritis, peritonitis, meningitis, as well as for the treatment of superficial secondary infections from burns or surgical wounds. Additionally, it is effective for severe infections related to the lungs such as pneumonia, sepsis, lung abscess, and empyema. It is particularly suitable for the treatment of severe infections that are not effectively treated with penicillin or cephalosporin antibiotics. When taken orally, it is used to treat antibiotic-related gastrointestinal infections such as colitis caused by Clostridium difficile. Thus, this drug is utilized for the treatment of various serious bacterial infections.

Dosage and Administration

Adult dosage

Adults: 500mg (potency) intravenously every 6 hours or 1g (potency) every 12 hours. For oral administration: 500-2000mg daily, divided into 3-4 doses for 7-10 days. The total daily dose should not exceed 2g.

Children's dosage

Children: 10mg/kg (potency) intravenously every 6 hours. Infants: 10-15mg/kg (potency) intravenously every 12 hours. Infants, newborns: 10-15mg/kg

Precautions

This medication should not be used in patients who have previously experienced severe allergic reactions such as shock due to this drug. Additionally, it is safe not to administer this drug to patients who have had hypersensitivity reactions to this or other peptide antibiotics or aminoglycoside antibiotics. Special caution should be taken when administering to patients with hearing impairment or those who have experienced hearing problems from this class of antibiotics. Patients with impaired kidney function should use this medication cautiously while frequently monitoring blood concentration, as it can accumulate in the body. Patients with liver dysfunction should also be careful as this drug may worsen liver function. Elderly individuals, premature infants, and newborns may have weaker physical functions, so extra caution should be exercised. Patients with damage to the vestibular apparatus or cochlea should also be monitored for side effects when using this drug. This drug may rarely cause severe allergic reactions or shock, so patients' conditions should be closely observed during administration. Gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur, so report any symptoms that arise. Changes in blood cell count may occur, making regular blood tests important. Central nervous system side effects such as dizziness, tinnitus, and hearing loss may occur, requiring observation, including hearing tests. Liver function tests should be performed regularly, and any abnormal signs should be reported immediately. Kidney function tests should also be done frequently; if kidney damage is suspected, administration should be stopped or adjusted. Severe rashes or inflammation of the skin may occur, so skin condition should be carefully monitored. Rapid infusion may cause flushing or pain in the face, neck, or trunk, and muscle cramps, so it is safer to administer slowly. Prolonged use of this drug may lead to resistance, so it is best to administer it only for the necessary duration. The risk of side effects increases when used with other neurotoxic or nephrotoxic drugs, so follow the physician's instructions. Women who are pregnant or may become pregnant should be cautious as the effects of this drug on the fetus are not clear. Nursing mothers should avoid administration or stop breastfeeding due to the possibility of transfer into breast milk. Children and the elderly may have weaker kidney function, thus requiring dosage adjustments and kidney function tests. Overdosage can lead to serious side effects such as renal failure or hearing loss, so seek medical attention immediately. This medication must be administered intravenously; intramuscular injections or other routes can cause tissue damage. When administering, it should be diluted and infused slowly, changing the injection site frequently to help prevent side effects. If the infusion speed is too fast, it may cause hypotension or heart issues, so it should be administered over at least 60 minutes. This drug should not be mixed with other antibiotics, and the condition of the solution should be checked before administration.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylaxis symptoms, urticaria, chest tightness, difficulty breathing, cold sweat, pallor, exfoliative dermatitis, bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, rash, erythema, facial flushing, hypotension, wheezing, respiratory distress, drug hypersensitivity syndrome (DRESS), acute generalized exanthematous pustulosis (AGEP), severe cutaneous adverse reactions (SCAR), Drug-induced hypersensitivity

Mild side effects

  • Loose stools
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • decreased red blood cells
  • decreased white blood cells
  • decreased platelets
  • increased eosinophils
  • dizziness
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  • tinnitus
  • hearing decrease
  • increased bilirubin
  • AST
  • ALT
  • ALP
  • increased LDH
  • γ-GTP
  • LAP
  • increased BUN
  • creatinine
  • fever
  • phlebitis
  • venous inflammation
  • nausea
  • chills
  • maculopapular rash
  • purpura
  • vesicular rash
  • rash

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the drug for a long time.

Appearance and packaging

Appearance

A colorless and transparent vial containing white or pale yellowish freeze-dried powder for injection

Package unit

20mL 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

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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.