Medication info

Toprasin Injection (Tobramycin) (Vial)

Prescription medication근육 · 정맥
Ingredient · strength
Tobramycin›40mg / 1mL
Manufacturer / importer
한국유니온제약(주)
Appearance
A colorless liquid in a colorless transparent vial
Packaging
1.5ml, 2ml, 2.5ml × 10 vials
Approval status
Active

MFDS item code 200401647 · Notified 2004.08.18

Summary

Main use
Treatment of central nervous system (meningitis), respiratory (bronchitis, pneumonia), and gastrointestinal infections
Who receives it
Adults · Children
Adult administration
In cases of severe infection, as tobramycin, administer 3mg (potency) per kg of body weight, divided into 3 doses by intravenous or intramuscular injection. In life-threatening infections, up to 5mg (potency) per kg of body weight may be given, divided into 3-4 doses, and as symptoms improve, it should be reduced to 3mg (potency) per kg of body weight. Do not exceed 5mg (potency) per kg of body weight without measuring serum concentrations.
Child administration
Daily dose of 5mg (potency) per kg of body weight, divided into 3-4 doses given intravenously or intramuscularly. Newborns (under 1 week old): Administer 4mg (potency) per kg of body weight every 12 hours in divided doses. Children.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of central nervous system (meningitis), respiratory (bronchitis, pneumonia), and gastrointestinal infections

  • Meningitis
  • central nervous system infections
  • bronchitis
  • bronchiectasis
  • pneumonia
  • peritonitis
  • gastrointestinal infections
  • subcutaneous abscesses
  • boils
  • soft tissue infections
  • burns
  • postoperative wound infections
View approved original text

This medication is effective against a variety of harmful bacteria, including Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus. It is used for central nervous system infections such as meningitis, respiratory infections such as bronchitis and pneumonia, and gastrointestinal infections such as peritonitis. It is also effective against skin and soft tissue infections like subcutaneous abscesses, soft tissue infections, and burn infections, and can be used for postoperative infections and osteomyelitis. It is utilized for serious and recurrent urinary tract infections such as sepsis, pyelonephritis, and cystitis. This medication helps treat a wide range of bacterial infections.

How it is given

Adult administration

In cases of severe infection, as tobramycin, administer 3mg (potency) per kg of body weight, divided into 3 doses by intravenous or intramuscular injection. In life-threatening infections, up to 5mg (potency) per kg of body weight may be given, divided into 3-4 doses, and as symptoms improve, it should be reduced to 3mg (potency) per kg of body weight. Do not exceed 5mg (potency) per kg of body weight without measuring serum concentrations.

Child administration

Daily dose of 5mg (potency) per kg of body weight, divided into 3-4 doses given intravenously or intramuscularly. Newborns (under 1 week old): Administer 4mg (potency) per kg of body weight every 12 hours in divided doses. Children.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this drug, aminoglycoside antibiotics, or bacitracin, those with ear diseases, severe kidney dysfunction, pregnant or breastfeeding women, patients with muscle disorders, those with bronchial asthma, and patients with eighth cranial nerve disorders should not use this medication. Additionally, this drug should be used cautiously in some patients. Special care is necessary for those with a family history of hearing loss, those with weak kidney or liver function, premature infants or newborns, the elderly, and patients who have difficulty with oral intake. This drug contains sodium bisulfite, which can cause allergic reactions or asthma attacks, so asthmatic patients should exercise particular caution. When using this drug, various side effects may occur, so careful monitoring is essential. Rarely, symptoms such as shock, gastrointestinal issues, blood abnormalities, central nervous system symptoms, liver and kidney dysfunction, skin rashes, allergic reactions, vitamin deficiency signs, injection site pain may occur. If any of these symptoms appear, consult a physician immediately. To prevent the development of resistant bacteria, it is advisable to check for susceptibility and administer the drug for only the minimum required duration. Furthermore, due to the risk of hearing damage and kidney impairment, the duration of treatment should ideally not exceed 10 days, and if prolonged use is necessary, regular blood concentration tests and hearing tests are required. This drug may interact with other medications, so caution is needed, especially when used with drugs that affect the kidneys or those with neuromuscular blocking effects. When used in conjunction with anticoagulants, frequent blood tests are required to reduce the risk of bleeding. During pregnancy, it may cause serious nerve damage to the newborn, so it should be used only when absolutely necessary, and during breastfeeding, it is safer to discontinue use. For newborns or low birth weight infants, kidney function is immature, so the dosage interval should be extended. Caution is also required in the elderly due to decreased kidney function and increased bleeding risk, and the dosage and administration interval should be adjusted accordingly. In cases of overdose, kidney dysfunction, hearing damage, and respiratory distress may occur, and healthcare personnel should be notified immediately for appropriate treatment. This medication may lose effectiveness when mixed with beta-lactam antibiotics for injection, so it must be administered through a different route. Finally, caution is advised when administering to patients receiving large-volume transfusions, as neuromuscular blocking symptoms and respiratory paralysis may occur. Some strains of bacteria with resistance to this drug have been reported, so it is important to decide on its use based on appropriate testing during infection treatment.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, and other severe allergic reactions.
  • Shock.
  • Severe skin reactions such as exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
  • Asthma attacks, difficulty breathing.
  • Jaundice of the skin or eyes, generalized weakness.
  • Acute renal failure, severe kidney impairment.
  • Sudden and severe headaches, confusion, visual disturbances, paralysis.
  • Respiratory failure due to neuromuscular blockade.

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • stomatitis
  • diarrhea
  • anemia
  • leukopenia
  • leukocytosis
  • granulocytosis
  • eosinophilia
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  • thrombocytopenia
  • dizziness
  • tinnitus
  • hearing loss
  • ear pain
  • ear fullness sensation
  • numbness of lips and limbs
  • drowsiness
  • headache
  • lethargy
  • confusion
  • local numbness
  • heaviness
  • delirium
  • loss of spatial perception
  • ALT increase
  • AST increase
  • serum LDH increase
  • bilirubin increase
  • BUN increase
  • NPN increase

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

Storage

This medication must be stored in a sealed container to avoid contact with air, and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness and safety of the drug.

Appearance and packaging

Appearance

A colorless liquid in a colorless transparent vial

Package unit

1.5ml, 2ml, 2.5ml × 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.

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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.