Medication info

Roteplus Eye Suspension (Loteprednol Etabonate, Tobramycin)

Prescription medicationEye drops
Ingredient · strength
Loteprednol Etabonate›5mg / 1mLTobramycin›3mg / 1mL
Manufacturer / importer
한림제약(주)
Appearance
A suspension in a white to pale yellow solution contained in an opaque white plastic bottle.
Packaging
5mL/bottle
Approval status
Active

MFDS item code 201904465 · Approved 2019.06.28 · Insurance code 645306201

Summary

Main use
Treatment of bacterial eye infections and allergic conjunctivitis inflammation.
Who uses it
Adults
Adult dosage
Shake well before use. Instill 1-2 drops into the conjunctival sac of the infected eye, 4 times a day. The prescribed amount should not exceed 20mL, and the same prescription should not be continued without reevaluation.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Treatment of bacterial eye infections and allergic conjunctivitis inflammation.

  • Bacterial infection of the surface of the eye
  • steroid-responsive inflammation of seasonal allergic conjunctivitis.
View approved original text

This medication is used to treat steroid-responsive inflammation due to bacterial infection or the risk of infection associated with seasonal allergic conjunctivitis on the surface of the eye. Specifically, the antibiotic Tobramycin included in this medication is effective against a variety of pathogens such as Staphylococcus aureus, coagulase-negative staphylococci, some streptococci and pneumococci, Pseudomonas aeruginosa, and Escherichia coli. It also shows good therapeutic effects on strains that cause conjunctivitis, such as Haemophilus influenzae. By treating infections caused by these pathogens, it improves eye inflammation and symptoms.

Dosage and Administration

Adult dosage

Shake well before use. Instill 1-2 drops into the conjunctival sac of the infected eye, 4 times a day. The prescribed amount should not exceed 20mL, and the same prescription should not be continued without reevaluation.

Precautions

This medication is an eye drop containing a combination of corticosteroid and aminoglycoside antibiotic, used to treat inflammation and infections of the eyes. Prolonged use of this medication can lead to severe ophthalmic diseases such as optic nerve damage, glaucoma, and cataracts, so caution is required. If irritation or pain occurs in the eyes, it is important to stop using it immediately and consult a physician. This medication should not be used if there is a viral infection in the eyes or viral diseases such as conjunctivitis or keratitis. Furthermore, it should be avoided if there is a known allergy to any of the components of this drug or if hypersensitivity is suspected. During use, side effects such as increased intraocular pressure, blurred vision, eye redness, itching, etc. may occur; if symptoms persist or worsen, notify a healthcare professional. It is crucial to use this medication according to the accurate dosage and administration as directed by an ophthalmologist. If wearing soft contact lenses, they must be removed before administration, and lenses can be reapplied only after 30 minutes post-instillation. Use during pregnancy or breastfeeding should be done cautiously, considering its impact on the fetus or infant, and should be administered only after consulting a physician. Use is not recommended for children due to insufficient safety and efficacy data. This medication should be stored in a refrigerator, and must be used within 4 weeks after opening, with any remaining medication being discarded. Additionally, this medication should not be injected directly into the eyes, and it should be shaken well before use. Caution is advised when driving or operating machinery, as temporary blurred vision may occur.

Side effects and when to seek care immediately

Serious side effects

Increased intraocular pressure, optic nerve damage, decreased vision and visual field, posterior subcapsular cataract formation, delayed wound healing, secondary eye infections including herpes simplex, corneal or scleral perforation, secondary infections, severe allergic reactions (including hypersensitivity).

Mild side effects

  • Redness
  • superficial punctate keratitis
  • burning sensation after instillation
  • eye pain
  • visual disturbances
  • discharge
  • itching
  • tearing abnormalities
  • photophobia
  • corneal deposits
Show 20 more
  • discomfort in the eyes
  • eyelid abnormalities
  • headache
  • rhinitis
  • pharyngitis
  • conjunctival edema
  • dry eyes
  • tearing syndrome
  • foreign body sensation
  • conjunctivitis
  • keratopathy
  • eyelid erythema
  • keratoconjunctivitis
  • eye irritation/pain/discomfort
  • papillae
  • uveitis
  • local hypersensitivity
  • eyelid itching
  • swelling
  • conjunctival erythema.

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also important to keep it refrigerated at a temperature between 2 to 8 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A suspension in a white to pale yellow solution contained in an opaque white plastic bottle.

Package unit

5mL/bottle

Questions about this medicine

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

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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.