Medication info

Hutodex Ophthalmic Solution

Prescription medicationEye drops점안Approval withdrawn
Ingredient · strength
Tobramycin›3mg / 1mLDexamethasone›1mg / 1mL
Manufacturer / importer
(주)휴온스
Appearance
An ophthalmic solution in a colorless transparent plastic container filled with a white suspension
Packaging
6 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 202003342 · Notified 2020.05.08

This product's status changed to Approval withdrawn on 2023.11.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(Infections) Treatment of various bacterial infections and (Ophthalmic diseases) Improvement of eye inflammation
Who applies the drops
Adults
Adult eye dose
Adults: Instill 1-2 drops into the conjunctival sac at intervals of 4-6 hours. During the first 24-48 hours, instill 1-2 drops every 2 hours, and as symptoms improve, gradually reduce the dosage without stopping it abruptly.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

(Infections) Treatment of various bacterial infections and (Ophthalmic diseases) Improvement of eye inflammation

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

This medication is used for the treatment of various bacterial infections caused by Tobramycin-sensitive bacteria. This includes infections caused by Staphylococcus aureus and Staphylococcus epidermidis, penicillin-resistant staphylococcus infections, group A β-hemolytic streptococcus, viridans streptococci, and pneumococcal infections. It is also effective in treating infections caused by aerobic enterobacteria such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Additionally, it is used for steroid-responsive inflammation and ophthalmic diseases involving the eyes, aiding in superficial bacterial infections and inflammation of the eyelids, conjunctiva, cornea, and anterior segment of the eye, as well as chronic anterior uveitis. Moreover, it is effective in treating corneal damage caused by chemicals, radiation, thermal trauma, or foreign bodies. Thus, this medication is used for improvement of various bacterial infections and eye-related inflammatory disorders.

How to apply drops

Adult eye dose

Adults: Instill 1-2 drops into the conjunctival sac at intervals of 4-6 hours. During the first 24-48 hours, instill 1-2 drops every 2 hours, and as symptoms improve, gradually reduce the dosage without stopping it abruptly.

Precautions

This medication should not be used in patients with viral eye diseases, tuberculosis, fungal infections, those allergic to this medication, or in children and nursing mothers. During use, local side effects such as eyelid itching, swelling, and conjunctival hyperemia may occur, and serious side effects such as optic nerve damage, glaucoma, cataract, corneal perforation, and delayed wound healing can also occur. When used with other aminoglycoside antibiotics, blood concentration must be closely monitored, and usage should be discontinued immediately if side effects appear. Care is needed when a steroid component is present in cases of acute eye infections, as it may mask or worsen the infection. Long-term use may result in fungal infections of the cornea or secondary bacterial infections, so continuous monitoring is required. Caution should be taken as overuse may lead to keratitis, erythema, edema, eyelid itching, and increased tears. Vision impairment such as blurriness has been reported, so if such symptoms appear, consultation with an ophthalmologist is necessary. Long-term use may increase fungi or resistant pathogens, and cross-reactivity may occur with other aminoglycoside medications. Particular caution is required in patients infected with varicella or measles, and history and vaccination status should be thoroughly checked to minimize infection risks. Women who are pregnant or may become pregnant must carefully consider the benefits and risks before using this medication. Safety and effectiveness have not been established for use in children, hence it is advisable not to use it. This medication should only be used for ophthalmic application, and care should be taken not to let the container tip directly touch the eye. Avoid sharing this product, and for contamination prevention, it is safer to use it personally only. During storage, keep it out of reach of children, avoid direct sunlight, and store it in a cool, dry place. Additionally, to prevent misuse and maintain the quality of the medication, do not transfer it to another container.

Side effects and when to seek care immediately

Mild side effects

Eyelid itching and swelling, conjunctival redness, punctate keratitis, erythema, increased tearing, blurred vision, decreased vision and visual fields, cataract formation, corneal perforation, delayed wound healing, corneal fungal infections, secondary bacterial infections due to immunosuppression

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. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

An ophthalmic solution in a colorless transparent plastic container filled with a white suspension

Package unit

6 milliliters/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.