Medication info

Tobradex Eye Drops

Prescription medicationEye drops점안
Ingredient · strength
Tobramycin›3mg / 1mLDexamethasone›1mg / 1mL
Manufacturer / importer
한국노바티스(주)
Appearance
An opaque white suspension contained in a white plastic bottle.
Packaging
5mL/bottle
Approval status
Active

MFDS item code 199403252 · Notified 1994.11.25 · Insurance code 653603001

Summary

Main use
(Infections) Treatment of various bacterial infections, (Ophthalmic conditions) Improvement of eye inflammation and trauma
Who applies the drops
Adults
Adult eye dose
Instill 1-2 drops into the conjunctival sac every 4-6 hours. For the initial 24-48 hours, instill 1-2 drops every 2 hours, and gradually reduce the frequency if symptoms improve. Do not discontinue use prematurely.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

(Infections) Treatment of various bacterial infections, (Ophthalmic conditions) Improvement of eye inflammation and trauma

  • Infections
  • superficial bacterial infections
  • blepharitis and conjunctival inflammation
  • keratitis
  • anterior uveitis
  • chronic anterior uveitis
  • corneal injuries
View approved original text

This medication is used to treat infections caused by various bacteria that are sensitive to tobramycin. This includes staphylococci such as Staphylococcus aureus and Staphylococcus epidermidis, some streptococci and pneumococci, and various aerobic gram-negative bacilli, including Pseudomonas aeruginosa. It is also effective in treating steroid-responsive inflammatory conditions of the eye, for example, keratitis, conjunctivitis, anterior uveitis, chronic anterior uveitis, and corneal injuries due to trauma. This drug serves to improve the symptoms of patients with complex infections and inflammatory ophthalmic conditions.

How to apply drops

Adult eye dose

Instill 1-2 drops into the conjunctival sac every 4-6 hours. For the initial 24-48 hours, instill 1-2 drops every 2 hours, and gradually reduce the frequency if symptoms improve. Do not discontinue use prematurely.

Precautions

This medication should not be used by individuals allergic to the active or inactive ingredients. It should also not be administered in cases of simple herpes keratitis or viral infections of the cornea and conjunctiva. It is contraindicated in patients with fungal ophthalmic infections, untreated parasitic infections, or mycobacterial infections. It is advisable for children and nursing mothers to avoid this medication. During its use, side effects such as eye pain, itching, irritation, and redness may occur, and in rare cases, symptoms like keratitis or blurred vision may also be experienced. Immediate discontinuation is necessary in case of hypersensitivity reactions, including skin rash, hives, and in severe cases, anaphylaxis. Caution is advised as there may be a cross-reaction with other aminoglycosides. Patients undergoing systemic aminoglycoside therapy are at risk of neurotoxicity and nephrotoxicity, therefore caution is warranted when used together. In particular, the risk of steroid-related side effects may increase when used with CYP3A4 inhibitors, requiring careful use. Long-term use can lead to ophthalmic conditions such as intraocular hypertension, glaucoma, and cataracts; thus, regular intraocular pressure checks are recommended. This medication may mask infection symptoms, so immediate consultation with healthcare professionals is advised if an infection is suspected. Prolonged use of the antibiotic component may lead to fungal or resistant microorganism overgrowth, necessitating caution. Contact lens wearers should remove their lenses during use and can only reinsert them after a certain period, avoiding contact with lenses. Patients who have never contracted chickenpox or measles or have not been vaccinated should assess their risk of infection before use and seek medical attention if an infection occurs. Temporary blurred vision may occur after instillation, so caution is advised during driving or operating machinery. Patients with or suspected of having neuromuscular disorders should be cautious as this medication may worsen muscle weakness. Use during pregnancy is not recommended, and breastfeeding mothers should avoid this medication. In cases of overdose, symptoms such as eye inflammation, swelling, or itching may occur, requiring caution. This medication is for topical use only; shake well before use and take care not to touch the tip of the container to the eye or eyelid. After use, securely close the container and avoid sharing to prevent contamination. After instillation, it is advisable to close the eyes and occlude the nasolacrimal duct to reduce systemic absorption. When used with other ophthalmic medications, a minimum interval of 5 minutes should be observed, and ointments should be applied last. When stored, keep this medication in a tightly sealed container out of reach of children, in a cool and dry place, away from direct sunlight.

Side effects and when to seek care immediately

Serious side effects

  • Increased intraocular pressure
  • anaphylaxis
  • hypersensitivity
  • keratitis
  • severe hives
  • significant swelling (edema)
  • urticaria
  • anaphylaxis reaction
  • vesicular reaction
  • severe rash with high fever
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  • skin peeling
  • difficulty breathing
  • ocular allergy
  • ocular hypertension
  • adrenal suppression
  • Cushing’s syndrome
  • optic nerve damage
  • reduced vision
  • visual field loss
  • severe neurological symptoms
  • significant swelling or urination issues
  • asthma attacks

Mild side effects

  • Eye pain
  • eye itching
  • eye discomfort
  • eye irritation
  • taste disturbance
  • dizziness
  • headache
  • eyelid swelling
  • eyelid redness
  • pupil dilation
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  • increased tear production
  • nausea
  • abdominal discomfort
  • erythema multiforme
  • facial swelling
  • rash
  • itching
  • eyelid itching
  • conjunctival redness
  • blurred vision
  • dry eye
  • eye redness

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

Storage

This medication should be kept in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to store it in a cool place, below 30 degrees Celsius, to maintain its efficacy.

Appearance and packaging

Appearance

An opaque white suspension contained in a white plastic bottle.

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.

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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.