Medication info

Tobraz 100 mg (Tobramycin)

Prescription medicationInjections
Ingredient · strength
Tobramycin›50mg / 1mL
Manufacturer / importer
(주)대웅제약
Appearance
A vial injection of colorless and transparent liquid
Packaging
1 vial (2 mL) x 10
Approval status
Active

MFDS item code 199300663 · Notified 1993.02.01 · Insurance code 641602441

Summary

Main use
Treatment of bacterial infections such as central nervous system infections and gastrointestinal infections
Who uses it
Adults · Children
Adult dosage
In cases of severe infections, tobramycin should be administered at 3 mg (activity) per kg of body weight, divided into 3 doses by intravenous or intramuscular injection daily. In life-threatening infections, this may be increased up to 5 mg (activity) per kg of body weight, divided into 3 to 4 doses, and once symptoms improve, the dose should be reduced to 3 mg (activity) per kg of body weight daily. Administration should not exceed 5 mg (activity) per kg of body weight without measuring serum concentration.
Children's dosage
For children, administer 5 mg (activity) per kg of body weight, divided into 3 to 4 doses by intravenous or intramuscular injection daily. For neonates (under 1 week old), administer 4 mg (activity) per kg of body weight every 12 hours, divided into doses.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Treatment of bacterial infections such as central nervous system infections and gastrointestinal infections

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

The injection is effective against various bacteria such as Pseudomonas, Proteus, Escherichia coli, and Klebsiella, and is used for the treatment of infections like meningitis and pneumonia, which are central nervous system infections, as well as gastrointestinal infections such as peritonitis, skin and soft tissue infections, postoperative wound infections, osteomyelitis, sepsis, and severe pyelonephritis or recurrent cystitis. The eye drops and ointment are effective against various bacterial strains related to eye infections such as Staphylococcus aureus, Streptococcus, and Pseudomonas, and are used to treat blepharitis, dacryocystitis, stye, conjunctivitis, keratitis, and corneal ulcers. Thus, these medicines can broadly respond to various bacterial infections, helping to improve symptoms and treat diseases.

Dosage and Administration

Adult dosage

In cases of severe infections, tobramycin should be administered at 3 mg (activity) per kg of body weight, divided into 3 doses by intravenous or intramuscular injection daily. In life-threatening infections, this may be increased up to 5 mg (activity) per kg of body weight, divided into 3 to 4 doses, and once symptoms improve, the dose should be reduced to 3 mg (activity) per kg of body weight daily. Administration should not exceed 5 mg (activity) per kg of body weight without measuring serum concentration.

Children's dosage

For children, administer 5 mg (activity) per kg of body weight, divided into 3 to 4 doses by intravenous or intramuscular injection daily. For neonates (under 1 week old), administer 4 mg (activity) per kg of body weight every 12 hours, divided into doses.

Precautions

This medication is an aminoglycoside antibiotic and should not be administered to certain patients. For example, it should not be used in patients who are allergic to this drug or similar antibiotics, patients with ear diseases, severe kidney dysfunction, pregnant or breastfeeding women, patients with muscle diseases, patients with bronchial asthma, and patients with 8th cranial nerve disorders. Additionally, patients with a family history of hearing loss or kidney dysfunction, patients with weak kidney or liver functions, premature infants or newborns, elderly patients, and those with poor nutritional status should use this medication with extra caution. Due to the sodium bisulfite included in this medication, allergic reactions or asthmatic attacks may occur, so care is needed. While it is rare, using this drug may lead to severe shock, gastrointestinal symptoms, blood abnormalities, central nervous system disorders, liver and kidney disorders, skin reactions, hypersensitivity reactions, vitamin deficiency symptoms, pain at the injection site, etc., so if any symptoms occur, healthcare personnel should be notified immediately. This medication should be used for the necessary duration following a susceptibility test to prevent the development of resistant bacteria, and it is advisable to carry out allergy reaction tests before administration. Furthermore, due to the risk of hearing loss and kidney damage, it is best not to exceed 10 days of administration, and when used for an extended period, serum drug levels and hearing tests should be checked regularly. This medication may interact with other drugs, especially those that affect the kidneys such as blood substitutes, anesthetics, muscle relaxants, anticoagulants, diuretics, etc., so caution is needed. During pregnancy, it may pose risks to the fetus, so it should only be used when necessary, and breastfeeding should be suspended during administration. Newborns or low-birth-weight infants have immature kidney function, thus requiring special caution, such as extending the dosing interval, while elderly patients have a higher risk of side effects due to declining kidney function, so they should be carefully monitored during administration. In case of overdose, kidney damage, hearing and vestibular dysfunction, respiratory paralysis, etc., can occur, and appropriate treatment should be sought immediately at a medical institution. Additionally, this medication should not be mixed with beta-lactam antibiotics and should be administered via other routes. Resistance has been reported for this medication against specific bacteria, therefore, it is vital to confirm the effectiveness of this drug through proper testing when treating infections.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), shock, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, difficulty breathing, respiratory depression, asthmatic attacks, jaundice, sudden and very severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, oliguria, severe edema, swelling accompanied by increased blood pressure

Mild side effects

Nausea, vomiting, loss of appetite, stomatitis, diarrhea, anemia, leukopenia, leukocytosis, neutrophilia, eosinophilia, thrombocytopenia, dizziness, tinnitus, hearing loss, otalgia, sensation of ear blockage, numbness of lips and limbs, drowsiness, headache, somnolence, confusion, loss of sensation in the area, heaviness, gibberish, loss of direction, increased ALT, AST, increased serum LDH, increased bilirubin (related to liver dysfunction), elevated BUN,

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

Storage

This medication should be stored in a sealed container that does not come into contact with air and should be kept away from direct sunlight and at room temperature. By storing it at appropriate temperatures, the effectiveness and safety of the drug can be maintained.

Appearance and packaging

Appearance

A vial injection of colorless and transparent liquid

Package unit

1 vial (2 mL) 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.