Medication info

Ocle Eye Drops (Tobramycin)

Prescription medicationEye drops
Ingredient · strength
Tobramycin›3mg / 1mL
Manufacturer / importer
한림제약(주)
Appearance
Colorless to slightly yellow ophthalmic solution
Packaging
5mL/bottle
Approval status
Active

MFDS item code 199402224 · Notified 1994.03.23 · Insurance code 645301271

Summary

Main use
Treatment of central nervous system and gastrointestinal infections, improvement of conjunctivitis and blepharitis.
Who uses it
Adults · Children
Adult dosage
In cases of severe infection, administer Tobramycin as 3 mg (potency) per kg of body weight divided into 3 doses per day by intravenous or intramuscular injection. In life-threatening infections, up to 5 mg (potency) per kg of body weight may be divided into 3 to 4 doses; once symptoms improve, the dose should be reduced to 3 mg (potency) per kg of body weight per day. Do not exceed 5 mg (potency) per kg of body weight without serum concentration measurements.
Children's dosage
Administer 5 mg (potency) per kg of body weight divided into 3 to 4 doses per day by intravenous or intramuscular injection. For newborns (under 1 week of age), administer 4 mg (potency) per kg of body weight divided every 12 hours.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Treatment of central nervous system and gastrointestinal infections, improvement of conjunctivitis and blepharitis.

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

This drug, used as an injectable form, is effective against various bacteria including Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus. It is used in the treatment of central nervous system infections such as meningitis, respiratory infections like bronchitis and pneumonia, gastrointestinal infections such as peritonitis, skin and soft tissue infections, osteomyelitis, sepsis, and renal and urinary tract infections like pyelonephritis and cystitis. Additionally, in the form of eye drops and ointment, it acts on various bacteria like Staphylococcus aureus, Streptococcus, and Pseudomonas aeruginosa, effectively treating blepharitis, dacryocystitis, styes, conjunctivitis, keratitis, and corneal ulcers. It improves a wide range of bacterial infections and is utilized in the treatment of various infections.

Dosage and Administration

Adult dosage

In cases of severe infection, administer Tobramycin as 3 mg (potency) per kg of body weight divided into 3 doses per day by intravenous or intramuscular injection. In life-threatening infections, up to 5 mg (potency) per kg of body weight may be divided into 3 to 4 doses; once symptoms improve, the dose should be reduced to 3 mg (potency) per kg of body weight per day. Do not exceed 5 mg (potency) per kg of body weight without serum concentration measurements.

Children's dosage

Administer 5 mg (potency) per kg of body weight divided into 3 to 4 doses per day by intravenous or intramuscular injection. For newborns (under 1 week of age), administer 4 mg (potency) per kg of body weight divided every 12 hours.

Precautions

This drug is an aminoglycoside antibiotic and should not be given to certain patients. For example, patients who have allergies to this drug or similar drugs, patients with ear-related diseases, patients with severe kidney issues, pregnant or nursing women, patients with muscle disorders, asthma patients, and those with specific neurological disorders should not use this drug. Additionally, patients with a family history of hearing loss or impaired kidney or liver function, newborns or premature infants, the elderly, and individuals with poor nutritional status should use this drug with caution. This drug may rarely cause severe allergic reactions, gastrointestinal issues, blood disorders, neurological symptoms (dizziness, tinnitus, hearing loss, etc.), liver or kidney function abnormalities, skin diseases, and vitamin deficiency symptoms, so one should notify a doctor immediately if symptoms occur. During treatment, it is crucial to check the drug susceptibility of the infecting bacteria to prevent the emergence of resistant strains and to only administer it for the necessary period. Patients with impaired kidney function and the elderly should regularly monitor serum drug concentrations to reduce the risk of side effects, and hearing tests are recommended. This drug can affect the kidneys or nervous system when used in conjunction with specific other drugs, thus caution is necessary during combined administration. During pregnancy, it may cause ear damage to the newborn, so it should be used only when necessary; during breastfeeding, it is best to discontinue its use as it can be transmitted in breast milk. In children, as kidneys may be immature leading to elevated drug concentrations, dosing intervals must be adjusted. In case of overdose, kidney damage, hearing issues, or breathing difficulties may occur, requiring prompt treatment. When used in the form of eye drops or ointments, eye irritation, itching, or redness may occur; if symptoms appear, usage should be discontinued. Contact lens wearers should avoid wearing lenses during treatment, and one should exercise caution when driving or operating machinery as vision may become blurred. While using this drug, it is important to maintain proper hygiene to prevent the spread of infecting bacteria and to adhere to the treatment duration.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, high fever accompanied by severe rash, blisters, peeling of skin, pain in oral/ocular mucosa, difficulty breathing or wheezing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

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
  • somnolence
  • mental confusion
  • localized loss of sensation
  • heaviness in the head
  • incoherence
  • disorientation
  • elevated ALT
  • elevated AST
  • increased serum LDH
  • increased bilirubin
  • edema
  • elevated BUN
  • NPN.

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

Storage

This drug may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This way, the efficacy of the drug can be preserved for a longer period.

Appearance and packaging

Appearance

Colorless to slightly yellow ophthalmic solution

Package unit

5mL/bottle

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.