Medication info

Tobradex Eye Drops

Prescription medicationEye drops점안Approval withdrawn
Ingredient · strength
Tobramycin›3mg / 1mLDexamethasone›1mg / 1mL
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
A white, suspension eye drop in a transparent plastic bottle
Packaging
6mL/bottle
Approval status
Approval withdrawn

MFDS item code 201708272 · Notified 2017.12.08

This product's status changed to Approval withdrawn on 2023.10.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections by susceptible bacteria and steroid-responsive eye inflammation
Who applies the drops
Adults
Adult eye dose
Instill 1-2 drops into the conjunctival sac every 4-6 hours. Initially, for the first 24-48 hours, instill 1-2 drops every 2 hours, and once symptoms improve, gradually reduce the dosage without stopping early.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment of infections by susceptible bacteria and steroid-responsive eye inflammation

  • Staphylococcus infections
  • β-hemolytic Streptococcus infections
  • Group C Streptococcus infections
  • Streptococcus pneumoniae infections
  • Pseudomonas infections
  • Escherichia coli infections
  • Klebsiella pneumoniae infections
  • aerobic enteric infections
  • Proteus mirabilis infections
  • Moraxella morganii infections
  • Moraxella nonliquefaciens infections
  • Haemophilus influenzae infections
View approved original text

This medication is used to treat infections caused by various bacteria sensitive to tobramycin. These include Staphylococcus aureus, Staphylococcus epidermidis, penicillin-resistant strains, some Streptococcus, Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, among others. It is also effective for inflammation of the eye that responds to steroids and various ophthalmic diseases, for example, bacterial keratitis, conjunctivitis, anterior uveitis, and corneal damage. This medication is used to effectively improve various bacterial infections and treat symptoms related to eye inflammation.

How to apply drops

Adult eye dose

Instill 1-2 drops into the conjunctival sac every 4-6 hours. Initially, for the first 24-48 hours, instill 1-2 drops every 2 hours, and once symptoms improve, gradually reduce the dosage without stopping early.

Precautions

This medication should not be used in patients with viral diseases of the eye, such as viral keratitis or conjunctivitis, smallpox, or chickenpox. Additionally, it is safer not to administer to individuals allergic to this medication, children, and nursing mothers. Local side effects such as eyelid itching, swelling, and conjunctival hyperemia may occur during use, so caution is advised. There is a possibility of serious ophthalmic problems like optic nerve damage, glaucoma, and cataracts, so if any abnormal symptoms appear, consult a physician immediately. When used in conjunction with certain antibiotics, blood levels should be monitored periodically, and usage should be discontinued if sensitivity reactions occur. When there is an acute infection in the eye, steroid components may exacerbate the infection, so caution is warranted. Prolonged use may pose a risk of corneal fungal infections or secondary bacterial infections, so it is crucial to inform medical personnel if symptoms persist. Overuse may result in punctate keratitis, erythema, increased tears, and other side effects; thus, it is essential to adhere to the prescribed dosage. Blurring of vision may occur rarely, so if vision changes are noted, immediate examination is necessary. Prolonged use may allow non-sensitive pathogens like fungal infections to proliferate, hence caution is required. Furthermore, there may be cross-reaction with other aminoglycoside antibiotics, so it is important to inform of any other medications being taken. For patients infected with chickenpox or measles, it is necessary to check the medical history and vaccination status before using this medication, and careful monitoring is essential to minimize infection risk. The safety of this medication in pregnant women or those who may become pregnant has not been established; it should only be used when the benefits of treatment outweigh the risks. Its safety and effectiveness in children have not been confirmed, so it's best not to use it. This medication is for ophthalmic use only and care should be taken to avoid direct contact with the tip of the container in the eye. Avoid sharing and it is safest to use a personal container to prevent contamination. Store in a cool, dry place out of the reach of children, and away from direct sunlight. Do not transfer to other containers; maintain the quality by storing in the original container.

Side effects and when to seek care immediately

Serious side effects

  • Optic nerve damage
  • glaucoma
  • decreased vision and field of vision
  • cataract formation
  • corneal perforation
  • delayed wound healing
  • potential for severe allergic reactions

Mild side effects

  • Eyelid itching and swelling
  • conjunctival redness
  • punctate keratitis
  • erythema
  • increased tearing
  • blurred vision

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is safest to keep it at room temperature between 1 to 30 degrees Celsius. Therefore, it should be placed in a cool, dry place until used, avoiding excessively hot or cold areas.

Appearance and packaging

Appearance

A white, suspension eye drop in a transparent plastic bottle

Package unit

6mL/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.

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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.