Medication info

RitoDex Eye Drops

Prescription medicationApproval withdrawn
Ingredient · strength
Tobramycin›Strength being verifiedDexamethasone›Strength being verified
Manufacturer / importer
(주)휴온스메디텍
Appearance
A colorless, translucent ophthalmic solution in a white suspension contained in a plastic bottle.
Packaging
6mL/bottle
Approval status
Approval withdrawn

MFDS item code 201402404 · Notified 2014.05.27

This product's status changed to Approval withdrawn on 2023.03.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(Infectious Disease) Treatment of various bacterial infections, (Ophthalmic Conditions) Improvement of eye inflammation and damage.
Who uses it
Adults
Adult dosage
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 as symptoms improve, gradually reduce the dosage but do not stop administration prematurely.

Ingredients

Manufacturer
(주)휴온스메디텍

Efficacy & effects

(Infectious Disease) Treatment of various bacterial infections, (Ophthalmic Conditions) Improvement of eye inflammation and damage.

  • Staphylococcal infections
  • beta-hemolytic Streptococcus infections
  • group C Streptococcus infections
  • Streptococcus pneumoniae infections
  • Pseudomonas aeruginosa infections
  • Escherichia coli infections
  • Klebsiella pneumoniae infections
  • aerobic intestinal bacteria infections
  • Proteus mirabilis infections
  • Morganelia morganii infections
  • Moraxella species infections
  • Haemophilus influenzae infections
View approved original text

This medication is used to treat various infections caused by Tobramycin-sensitive bacteria. This includes several strains of Staphylococcus, such as Staphylococcus aureus, coagulase-negative Staphylococci, as well as certain beta-hemolytic Streptococci, Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and various other bacteria. It is also effective against infections caused by aerobic intestinal bacteria, Proteus mirabilis, Haemophilus influenzae, and Acinetobacter calcoaceticus, among others. Additionally, it is used in the treatment of ocular diseases such as steroid-responsive eye inflammation and inflammation of the eyelids, conjunctiva, cornea, and anterior chamber of the eye, chronic anterior uveitis, and corneal injuries due to various traumas. This drug improves bacterial infections and various symptoms of eye inflammation.

Dosage and Administration

Adult dosage

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 as symptoms improve, gradually reduce the dosage but do not stop administration prematurely.

Precautions

This drug should not be used in patients with simple herpes keratitis of the epithelium, vaccinia, varicella, and viral diseases of the cornea and conjunctiva, ocular tuberculosis, or fungal infections of the eye. Additionally, it is not safe to administer this medication to patients who have allergic reactions to it, to children, or to breastfeeding women. Local side effects such as itching or swelling of the eyelids, conjunctival redness may occur; rare but serious side effects include optic nerve damage, glaucoma, and vision impairment. When using this drug together with other systemic aminoglycoside antibiotics, careful monitoring of blood concentrations is necessary, and administration should be stopped immediately if adverse reactions occur. In cases of acute purulent infection of the eye, it is important to note that the steroid components may worsen or mask the infection. Long-term use may lead to fungal infections of the cornea; thus, if corneal ulcers persist after treatment, the possibility of fungal infection should be considered, and secondary bacterial infections may occur due to immune suppression. Overuse may result in punctate keratitis, erythema, eyelid itching, and increased tearing, and, in rare cases, blurred vision. Prolonged use can lead to an increase in fungi or resistant pathogens, requiring caution, and cross-resistance with other aminoglycoside antibiotics may occur. Adequate treatment should be received during reinfection. In particular, if infected with varicella or measles during the use of this drug, it can have serious consequences, so the patient's history of varicella or measles and vaccination status should be checked before administration, and if infection is suspected or occurs, medical attention should be sought immediately. The safety of this drug during pregnancy has not been established; therefore, it should only be used by pregnant women or those who could become pregnant if the benefits outweigh the risks. The safety and efficacy in pediatric patients have not been sufficiently established. This drug is for ophthalmic use only and should not be injected into the eye. Care should be taken to avoid direct contact between the container opening and the eye during administration, and it is advisable not to share the product to prevent contamination. When storing, keep it out of reach of children, avoid direct sunlight, and store in a cool, dry place. Additionally, to avoid misuse and maintain quality, do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

  • Optic nerve damage
  • vision and field impairment
  • cataract formation
  • perforation of the eye
  • delayed wound healing
  • hypersensitivity
  • fungal infections of the cornea
  • secondary bacterial infections.

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 drug is sensitive to air and moisture and must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A colorless, translucent ophthalmic solution in a white suspension contained in a 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.

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.