Medication info

Tobramycin-Dexamethasone Eye Drops

Prescription medicationApproval withdrawn
Ingredient · strength
Tobramycin›Strength being verifiedDexamethasone›Strength being verified
Manufacturer / importer
(주)태준제약
Appearance
A white suspension in a clear plastic container
Packaging
5mL/bottle x 1 bottle/carton
Approval status
Approval withdrawn

MFDS item code 200202623 · Notified 2002.12.04

This product's status changed to Approval withdrawn on 2023.06.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections caused by sensitive bacteria and steroid-responsive eye inflammation
Who uses it
Adults
Adult dosage
Administer 1-2 drops into the conjunctival sac every 4-6 hours. Initially, for the first 24-48 hours, administer 1-2 drops every 2 hours and gradually reduce as symptoms improve. Do not stop using it early.

Ingredients

Manufacturer
(주)태준제약

Efficacy & effects

Treatment of infections caused by sensitive bacteria and steroid-responsive eye inflammation

  • Staphylococcal infections
  • β-hemolytic streptococcal infections
  • non-hemolytic streptococcal infections
  • pneumococcal infections
  • pseudomonas infections
  • escherichia coli infections
  • klebsiella pneumoniae infections
  • aerobic intestinal bacteria infections
  • proteus mirabilis infections
  • moraxella morganii infections
  • acinetobacter species infections
  • haemophilus influenzae infections
View approved original text

This medication is used for the treatment of infections caused by various bacteria that are sensitive to tobramycin. This includes staphylococcus aureus, coagulase-negative staphylococci, penicillin-resistant bacteria, some streptococci, pseudomonas aeruginosa, escherichia coli, klebsiella pneumoniae, and haemophilus influenzae. It is also effective for inflammation of the eye and various ophthalmic diseases that respond to steroids. This includes superficial bacterial infections, inflammation of the eyelids and conjunctiva of the eye, cornea, anterior segment of the eye, chronic iridocyclitis, and corneal damage due to chemicals, radiation, heat, trauma, or foreign body penetration. This medicine is used for the treatment of not only bacterial infections but also inflammatory ophthalmic diseases.

Dosage and Administration

Adult dosage

Administer 1-2 drops into the conjunctival sac every 4-6 hours. Initially, for the first 24-48 hours, administer 1-2 drops every 2 hours and gradually reduce as symptoms improve. Do not stop using it early.

Precautions

This medication should not be used in patients with viral keratitis, vaccinia, chickenpox, ocular tuberculosis, or fungal diseases of the eye. Additionally, it is not safe for individuals with an allergic reaction to this medication, or for children and breastfeeding individuals. Local side effects such as eyelid itching, swelling, and conjunctival hyperemia may occur during use. Rarely, serious eye diseases such as optic nerve damage, glaucoma, or cataracts may appear. Caution is necessary when used in conjunction with other aminoglycoside antibiotics, monitoring serum concentrations closely, and immediately discontinuing use if adverse reactions occur. Steroid components may worsen an acute purulent eye infection, so caution is advised. Prolonged use may increase the risk of fungal infections of the cornea or secondary bacterial infections, requiring ongoing observation. Overuse may result in symptoms such as punctate keratitis, erythema, edema, eyelid itching, and increased tearing. Vision disturbances like blurred vision may occur; if such symptoms appear, consult an ophthalmologist immediately. Prolonged use may allow the proliferation of fungi or resistant bacteria and requires caution, with proper treatment being necessary for reinfection. Using systemic or localized corticosteroids may result in visual disturbances, so evaluation by a specialist is required if blurred vision or changes in vision occur. During pregnancy, safety has not been fully established and should only be used if the benefits of treatment outweigh the risks. Safety and efficacy in children have not been established, and use is best avoided. This medication should not be injected directly into the eye and should only be used as an eye drop, ensuring that the tip of the container does not come into contact with the eye during use. To prevent contamination, personal use is recommended, avoiding shared use. This medication should be kept out of reach of children and stored in a cool, dry place away from direct sunlight. It should not be transferred to another container, and it is important to confirm any history of infection with chickenpox or measles before administration. Patients with no history of chickenpox or measles or who have not been vaccinated should be particularly cautious to prevent infection, and if infection is suspected or occurs, immediate medical attention is needed. Even if there is a history of chickenpox or measles, care must be taken as the possibility of infection during use exists; ongoing careful observation is required.

Side effects and when to seek care immediately

Serious side effects

  • Optic nerve damage
  • decreased vision and field of vision
  • cataract formation
  • eyeball perforation
  • severe swelling (eyelid swelling)
  • and vision abnormalities.

Mild side effects

  • Eyelid itching
  • swelling
  • conjunctival redness
  • punctate keratitis
  • erythema
  • increased lacrimation
  • blurred vision
  • acute purulent eye infection
  • corneal fungal infection
  • secondary bacterial infections
Show 1 more
  • and delayed wound healing.

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

Storage

This medication may be degraded by air or light, so it should be stored in a sealed container. Additionally, it should be stored away from direct sunlight at a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A white suspension in a clear plastic container

Package unit

5mL/bottle x 1 bottle/carton

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.