Medication info

Tobraz 80mg (Tobramycin)

Prescription medicationInjections
Ingredient · strength
Tobramycin›40mg / 1mL
Manufacturer / importer
(주)대웅제약
Appearance
A vial injection containing a colorless and transparent liquid
Packaging
1 vial (2mL) X 10
Approval status
Active

MFDS item code 197900134 · Notified 1979.06.01 · Insurance code 641602451

Summary

Main use
Treatment of infections in the central nervous system and gastrointestinal tract, skin, and ophthalmic infections
Who uses it
Adults · Children
Adult dosage
In the case of severe infections, Tobramycin is administered intravenously or intramuscularly at 3mg (potency) per kg of body weight divided into 3 doses per day. In life-threatening infections, it may be administered up to 5mg (potency) per kg of body weight in 3 to 4 divided doses. If symptoms improve, the dosage should be reduced to 3mg (potency) per kg of body weight. It should not be administered in excess of 5mg (potency) per kg of body weight per day without serum concentration testing.
Children's dosage
In children, 5mg (potency) per kg of body weight is administered intravenously or intramuscularly in 3 to 4 divided doses per day. For neonates (under 1 week old), 4mg (potency) per kg of body weight is divided and administered every 12 hours.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Treatment of infections in the central nervous system and gastrointestinal tract, skin, and ophthalmic infections

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

The injection is effective against various bacteria including Pseudomonas aeruginosa, Proteus, Escherichia coli, and Staphylococcus aureus. This medication is used for central nervous system infections such as meningitis, pneumonia and bronchitis, gastrointestinal infections, soft tissue infections such as subcutaneous abscesses, burn and postoperative wound infections, osteomyelitis, sepsis, as well as severe pyelonephritis and cystitis. The eye drops and eye ointment are effective against various bacteria including Staphylococcus aureus, Streptococcus, and Pseudomonas aeruginosa, and are used to treat blepharitis, dacryocystitis, styes, conjunctivitis, keratitis, and corneal ulcers. Each formulation effectively treats infection and improves symptoms tailored to the infection site.

Dosage and Administration

Adult dosage

In the case of severe infections, Tobramycin is administered intravenously or intramuscularly at 3mg (potency) per kg of body weight divided into 3 doses per day. In life-threatening infections, it may be administered up to 5mg (potency) per kg of body weight in 3 to 4 divided doses. If symptoms improve, the dosage should be reduced to 3mg (potency) per kg of body weight. It should not be administered in excess of 5mg (potency) per kg of body weight per day without serum concentration testing.

Children's dosage

In children, 5mg (potency) per kg of body weight is administered intravenously or intramuscularly in 3 to 4 divided doses per day. For neonates (under 1 week old), 4mg (potency) per kg of body weight is divided and administered every 12 hours.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or to aminoglycoside antibiotics, bacitracin, those with inner ear and middle ear disease, severe renal impairment, pregnant or nursing women, those with muscle disorders, patients with bronchial asthma, and patients with disorders of the eighth cranial nerve should not be administered this drug. Additionally, this drug should be used cautiously in some patients. Patients with a family history of hearing loss, impaired kidney or liver function, premature infants or newborns, elderly patients, those unable to take orally, and individuals allergic to sulfites need to exercise caution. When using this medication, rare gastrointestinal symptoms such as shock, nausea, vomiting, loss of appetite, and diarrhea, as well as blood abnormalities, dizziness, tinnitus, and hearing loss may occur; hence, symptoms should be monitored closely. It can affect liver and kidney function, so regular testing is required. If skin rashes or hypersensitivity occur, administration should be stopped immediately. To prevent the emergence of resistant bacteria, sensitivity testing is recommended, and it should only be used for the necessary minimum duration. Moreover, to prevent hearing and kidney damage, it is advisable to limit the duration of administration to less than 10 days, and monitoring of blood concentration and hearing tests are recommended. Patients with mitochondrial genome mutations are at increased risk of ototoxicity and may need to consider alternative treatment options. This medication should be used with caution when taken alongside other nephrotoxic drugs, muscle relaxants, or anesthetics, and may affect blood coagulation, so the risk of bleeding should be monitored when used with anticoagulants. During pregnancy, it should be used cautiously as it can cause nerve damage to the newborn, and during breastfeeding, administration should be stopped. Newborns or premature infants may have immature kidney function, resulting in increased drug concentration, so dosing intervals should be adjusted. Elderly patients are at increased risk of side effects due to reduced kidney function, so care should be taken with dosing and intervals. In case of overdose, symptoms such as renal impairment, hearing damage, and respiratory distress may arise, requiring appropriate dialysis treatment and symptom-based care. Additionally, mixing this medication with beta-lactam antibiotics for injection can reduce efficacy, so administration via different routes is necessary. Lastly, patients who have received large-volume blood transfusions may be at risk of neuromuscular blockade and respiratory paralysis, thus requiring caution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), bronchial asthma, shock, acute renal failure, jaundice, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities, eighth cranial nerve disorders (dizziness, tinnitus, hearing loss, etc.), severe neurological symptoms, severe edema or urination abnormalities, respiratory depression, respiratory paralysis

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
  • paralysis sensation
  • drowsiness
  • headache
  • lethargy
  • mental confusion
  • loss of regional sensation
  • heaviness
  • hallucinations
  • loss of directional sense
  • ALT elevation
  • AST elevation
  • serum LDH elevation
  • bilirubin elevation
  • BUN increase
  • NPN increase
  • serum creatinine increase

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

Storage

This medication should be stored in a sealed container that prevents air or moisture from entering. It is advisable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

A vial injection containing a colorless and transparent liquid

Package unit

1 vial (2mL) X 10

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.