Medication info

Tobramycin Sulfate Injection 80 Milligrams

Prescription medication
Ingredient · strength
Tobramycin›40mg / 1mL
Manufacturer / importer
알보젠코리아(주)
Appearance
A colorless to light yellow transparent liquid contained in vials or ampoules
Packaging
50 ampoules (2mL/ampoule x 50)
Approval status
Active

MFDS item code 198800705 · Notified 1988.09.27 · Insurance code 652601623

Summary

Main use
Treatment of various bacterial infections including central nervous system infections and gastrointestinal infections
Who uses it
Adults · Children
Adult dosage
In cases of severe infection, tobramycin should be administered as 3 mg (dosage unit) per kg body weight divided into 3 doses intravenously or intramuscularly per day. In life-threatening infections, it may be given up to 5 mg (dosage unit) per kg body weight divided into 3-4 doses, and once symptoms improve, the dose should be reduced to 3 mg (dosage unit) per kg body weight per day. Do not exceed 5 mg (dosage unit) per kg body weight per day without measuring serum concentration.
Children's dosage
5 mg (dosage unit) per kg body weight divided into 3-4 doses and administered either intravenously or intramuscularly per day. In newborns (less than 1 week old), 4 mg (dosage unit) per kg body weight should be administered every 12 hours in divided doses. For children

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Treatment of various bacterial infections including central nervous system infections and gastrointestinal infections

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

When used as an injection, this medication is effective in treating infections caused by various bacteria, including Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus. It is frequently used for central nervous system infections like meningitis, respiratory infections such as bronchitis and pneumonia, gastrointestinal infections like peritonitis, as well as skin and soft tissue infections. Additionally, it is utilized for treating post-surgical wound infections, osteomyelitis, sepsis, pyelonephritis, and severe urinary tract infections. In the form of eye drops or ophthalmic ointment, it is primarily used to treat ophthalmic infections such as conjunctivitis, keratitis, and dacryocystitis. This drug is widely used for treating various infectious diseases and improves infected areas.

Dosage and Administration

Adult dosage

In cases of severe infection, tobramycin should be administered as 3 mg (dosage unit) per kg body weight divided into 3 doses intravenously or intramuscularly per day. In life-threatening infections, it may be given up to 5 mg (dosage unit) per kg body weight divided into 3-4 doses, and once symptoms improve, the dose should be reduced to 3 mg (dosage unit) per kg body weight per day. Do not exceed 5 mg (dosage unit) per kg body weight per day without measuring serum concentration.

Children's dosage

5 mg (dosage unit) per kg body weight divided into 3-4 doses and administered either intravenously or intramuscularly per day. In newborns (less than 1 week old), 4 mg (dosage unit) per kg body weight should be administered every 12 hours in divided doses. For children

Precautions

This drug is an aminoglycoside antibiotic primarily used for the treatment of infections and should be avoided in certain patients. First, it should not be administered to patients who have had allergic reactions to this drug or similar components. Additionally, it is not safe for patients with ear diseases, severe kidney dysfunction, pregnant or breastfeeding women, patients with muscle disorders, patients with bronchial asthma, or patients with disorders of the 8th cranial nerve. Patients with renal or hepatic dysfunction, a family history of hearing loss or existing hearing loss, newborns and premature infants, elderly individuals, and patients with poor nutritional status should be monitored particularly while using this drug, and regular blood drug concentration and hearing tests should be performed as necessary. This drug can induce allergic reactions; therefore, allergy status should be confirmed prior to use, and if symptoms such as rash, itching, or difficulty breathing occur, administration should be stopped immediately. Rarely, serious side effects may include shock, worsening of kidney function, hearing loss, and neurological symptoms, so if these symptoms occur, immediate consultation with medical personnel is required. Moreover, combining this drug with certain other medications may enhance nephrotoxic effects or neuromuscular blockade; thus, it is essential to inform about other medications being taken, especially anesthetics, muscle relaxants, diuretics, and anticoagulants. During pregnancy, there is a risk of fetal nerve damage, so it should only be used when necessary and under a doctor's judgment, and during breastfeeding, it is advisable to discontinue administration since this drug can be passed into breast milk. In children or the elderly, dosing adjustments and careful observation are necessary as their renal function may be weaker. In case of overdose, kidney impairment, hearing, and vestibular disturbances, and respiratory paralysis may occur, and treatments such as dialysis may be required. This drug should not be mixed with β-lactam antibiotics when injected, as efficacy may diminish, and patients wearing contact lenses should avoid wearing them during treatment. Finally, to prevent the development of resistant bacteria, it is crucial to administer this drug only for the appropriate duration based on susceptibility testing, and long-term use should be approached with caution regarding the overgrowth of resistant bacteria.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, shock, severe allergic reactions, high fever accompanied by severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanying cough and fever, jaundice, extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • stomatitis
  • diarrhea
  • anemia
  • leukopenia
  • leukocytosis
  • neutrophilia
  • eosinophilia
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  • thrombocytopenia
  • dizziness
  • tinnitus
  • hearing loss
  • ear pain
  • sensation of ear blockage
  • lip and limb numbness
  • drowsiness
  • headache
  • somnolence
  • psychosis
  • reduced sensory loss
  • heaviness
  • delirium
  • sense of direction loss
  • increase in ALT
  • increase in AST
  • increase in serum LDH
  • increase in bilirubin
  • edema
  • increased BUN
  • increased NPN

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

Storage

This medication should be stored in a sealed container to avoid contact with air and should be kept in a cool, room temperature location away from direct sunlight.

Appearance and packaging

Appearance

A colorless to light yellow transparent liquid contained in vials or ampoules

Package unit

50 ampoules (2mL/ampoule x 50)

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.