Medication info

Tobut Eye Drops

Prescription medicationApproval withdrawn
Ingredient · strength
Tobramycin›Strength being verifiedDexamethasone›Strength being verified
Manufacturer / importer
한국휴텍스제약(주)
Appearance
A white, suspension eye drop in a transparent plastic container
Packaging
6mL/bottle
Approval status
Approval withdrawn

MFDS item code 201803932 · Notified 2018.10.08

This product's status changed to Approval withdrawn on 2023.06.29. 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 (Ocular Diseases) Relief of eye inflammation
Who uses it
Adults
Adult dosage
For adults, 1-2 drops should be instilled into the conjunctival sac every 4-6 hours. During the first 24-48 hours, instill 1-2 drops every 2 hours; as symptoms improve, gradually reduce the dosage. Do not cease administration prematurely.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Infections) Treatment of various bacterial infections and (Ocular Diseases) Relief of eye inflammation

  • Staphylococcal infection
  • β-hemolytic streptococcal infection
  • group A streptococcal infection
  • pneumococcal infection
  • Pseudomonas aeruginosa infection
  • Escherichia coli infection
  • Klebsiella pneumoniae infection
  • aerobic intestinal bacterial infection
  • Proteus mirabilis infection
  • Morganella morganii infection
  • Corynebacterium xerosis infection
  • Haemophilus influenzae infection
View approved original text

This medication is effective for infections caused by various bacteria. It is particularly effective against Staphylococcus aureus, Staphylococcus epidermidis, and penicillin-resistant strains, as well as certain streptococci, pneumococci, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and other gram-negative bacteria. It also treats a broad range of bacterial infections including Haemophilus influenzae and conjunctivitis-causing bacteria, and Acinetobacter species. Furthermore, it is used for eye-related inflammation and ocular conditions, for example, superficial bacterial infections and inflammation of the eyelids, conjunctiva, cornea, and anterior segment of the eye, chronic uveitis, and corneal injuries caused by chemicals or trauma. Therefore, this drug is effectively used to treat various bacterial infections and eye inflammation diseases.

Dosage and Administration

Adult dosage

For adults, 1-2 drops should be instilled into the conjunctival sac every 4-6 hours. During the first 24-48 hours, instill 1-2 drops every 2 hours; as symptoms improve, gradually reduce the dosage. Do not cease administration prematurely.

Precautions

This medication should not be used by patients with viral eye diseases such as epithelial simplex herpes keratitis, vaccinia, or varicella, or by those with fungal eye diseases. Individuals allergic to this drug should avoid taking it, and it should not be used by children or nursing women. During use, local side effects such as eyelid itching, swelling, and conjunctival redness may occur, which should be monitored. Care should be taken while using this drug if there are existing eye diseases such as glaucoma or cataracts, or if symptoms of decreased vision and visual field occur. When used in conjunction with other aminoglycoside antibiotics, blood concentrations should be carefully monitored, and usage should be stopped immediately if adverse reactions occur. Caution is advised as steroid components may mask or worsen an acute eye infection. Long-term use of steroids may result in fungal infections of the cornea or secondary bacterial infections; therefore, if corneal ulcers persist, the possibility of fungal infection should be suspected. Overuse may lead to symptoms such as punctate keratitis, eye redness, swelling, eyelid itching, and increased tearing, so the dosage instructions must be strictly followed. Blurring of vision may rarely occur; if such symptoms arise, immediate consultation with a healthcare professional is necessary. Prolonged use may lead to the proliferation of fungi or resistant pathogens, so regular monitoring of the condition is required. If this medication is used during infections with varicella or measles, serious complications may arise, thus it is important to verify past medical history and vaccination status prior to administration and seek immediate medical attention if infections are suspected. During pregnancy, safety has not been established, and it should only be used when deemed absolutely necessary. Safety and efficacy in pediatric use have not been verified, so it is preferable to avoid use in children. This medication should only be used as eye drops and must not be directly injected into the eye; care should be taken to avoid contact between the container opening and the eye during administration. Avoid sharing this medication and keep it in a clean environment to prevent contamination, storing it in a cool and dry place out of the reach of children. Additionally, avoid direct sunlight and do not transfer it to another container, as this is important for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Optic nerve damage, glaucoma, decreased vision and visual field, cataract formation, eye perforation, delayed wound healing, hypersensitivity, fungal infections of the cornea, and secondary bacterial infections due to long-term steroid use, potential for masking and exacerbating infection, severe swelling (eyelid swelling), worsening of infectious diseases

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 tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

A white, suspension eye drop in a transparent plastic container

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.