Medication info

Samin Tobramycin Injection 80mg (Tobramycin)

Prescription medication
Ingredient · strength
Tobramycin›40mg / 1mL
Manufacturer / importer
삼진제약(주)
Appearance
A colorless to pale yellowish transparent liquid contained in a colorless transparent ampoule
Packaging
2mL-50 ampoules per box
Approval status
Active

MFDS item code 199901471 · Notified 1999.02.10 · Insurance code 647801091

Summary

Main use
Treatment of central nervous system and gastrointestinal infections, improvement of ophthalmic infections
Who uses it
Adults · Children
Adult dosage
For severe infections, administer 3mg (as potency) per kg of body weight divided into 3 intravenous or intramuscular injections each day. For life-threatening infections, the dosage can be increased to 5mg (as potency) per kg of body weight divided into 3 to 4 doses, and once improvement is seen, decrease to 3mg (as potency) per kg of body weight. Do not exceed 5mg (as potency) per kg of body weight without measuring serum concentrations.
Children's dosage
Children: Administer 6 to 7.5mg (as potency) per kg of body weight divided into 3 to 4 intravenous or intramuscular injections each day. Newborns (under 1 week old): Administer 4mg (as potency) per kg of body weight every 12 hours divided doses.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment of central nervous system and gastrointestinal infections, improvement of ophthalmic infections

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

The injection is used to treat infections caused by various bacteria such as Pseudomonas aeruginosa and Staphylococcus. It is effective against infections of the central nervous system and respiratory tract, such as meningitis, bronchitis, and pneumonia, as well as gastrointestinal infections like peritonitis. It also assists in the treatment of subcutaneous abscess, soft tissue infections, burns, postoperative infections, and bone infections. Additionally, it is used for treating sepsis, severe recurrent pyelonephritis, and cystitis. Meanwhile, ophthalmic solutions and ointments improve symptoms of ophthalmic infections such as blepharitis, dacryocystitis, stye, conjunctivitis, keratitis, and corneal ulcers. These medications effectively treat various bacterial infections.

Dosage and Administration

Adult dosage

For severe infections, administer 3mg (as potency) per kg of body weight divided into 3 intravenous or intramuscular injections each day. For life-threatening infections, the dosage can be increased to 5mg (as potency) per kg of body weight divided into 3 to 4 doses, and once improvement is seen, decrease to 3mg (as potency) per kg of body weight. Do not exceed 5mg (as potency) per kg of body weight without measuring serum concentrations.

Children's dosage

Children: Administer 6 to 7.5mg (as potency) per kg of body weight divided into 3 to 4 intravenous or intramuscular injections each day. Newborns (under 1 week old): Administer 4mg (as potency) per kg of body weight every 12 hours divided doses.

Precautions

When using this drug in injection form, care should be taken when opening the glass ampoule. If glass fragments are introduced, serious side effects may occur, so extra caution should be applied when using it for children or the elderly. This medication should not be administered to patients with allergies to this drug or similar antibiotics, patients with ear diseases, severe renal impairment, women who are pregnant or breastfeeding, patients with muscle disorders, patients with bronchial asthma, and patients with certain neurological disorders. Patients with impaired kidney or liver function, newborns or premature infants, elderly patients, and patients with poor nutritional status should be particularly careful while using this drug, as there may be symptoms of vitamin deficiency or allergic reactions, and they should be monitored closely. During administration of this drug, there may be symptoms such as dizziness, tinnitus, hearing loss, renal function impairment, skin rashes, or allergic symptoms; any abnormal symptoms should be promptly reported to the medical staff. It is important to use this medication for the minimum duration necessary to reduce the risk of resistant bacteria development, and to regularly check plasma drug concentrations to maintain appropriate dosing. Special caution is needed in patients with reduced renal function or those requiring prolonged administration. Additionally, the risk of renal toxicity or hearing damage may increase when used with other specific medications, so patients should consult with medical staff regarding concomitant medications. Women who are pregnant or breastfeeding must consult with a doctor before using this drug as it may cause adverse effects in newborns. In pediatric and elderly patients, renal function may be weak, so dosing intervals and amounts should be adjusted carefully. In case of overdose, severe symptoms such as reduced renal function, hearing loss, and shortness of breath may occur, and emergency treatment should be sought if these symptoms arise. This drug may lose its efficacy when mixed with beta-lactam antibiotics, so it is advisable to administer them using different routes. When using the ophthalmic solution or ointment form, irritation or inflammation may occur in the eye, so if symptoms develop, discontinuation and consultation with a doctor are necessary. Moreover, contact lens wear should be avoided during treatment, and caution should be observed when driving or operating machinery. This drug should not be injected directly into the eye, and care should be taken to avoid contact between the tube tip and the eye. Finally, some bacteria have reported resistance to this drug, so it is important to check the susceptibility of the infection-causing bacteria and develop an appropriate treatment plan.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe allergic reactions, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties with cough and fever, skin or eyes turning yellow (jaundice), severe malaise, liver abnormalities (jaundice), sudden and severe headache

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
  • feeling of ear blockage
  • lip and limb numbness
  • drowsiness
  • headache
  • lethargy
  • confusion
  • local loss of sensation
  • heaviness in the head
  • hallucinations
  • loss of direction
  • increase in ALT
  • increase in AST
  • increase in serum LDH
  • increase in bilirubin
  • edema
  • increase in BUN
  • increase in 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 ideally be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help retain the drug's effectiveness and ensure safe use.

Appearance and packaging

Appearance

A colorless to pale yellowish transparent liquid contained in a colorless transparent ampoule

Package unit

2mL-50 ampoules per box

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.