Medication info

Oflotoc Eye Drops (Ofloxacin)

Prescription medicationApproval withdrawn
Ingredient · strength
Ofloxacin›Strength being verified
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
A transparent liquid of pale yellow to light yellow color contained in a clear plastic bottle
Packaging
5mL/bottle
Approval status
Approval withdrawn

MFDS item code 201900055 · Notified 2019.01.08

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of eye infections (conjunctivitis, keratitis, etc.) and prevention of infection before and after ophthalmic surgery
Who uses it
Adults
Adult dosage
Instill (apply) 1 drop per dose, 3 times daily. The dose may be increased or decreased as appropriate according to symptoms.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

Treatment of eye infections (conjunctivitis, keratitis, etc.) and prevention of infection before and after ophthalmic surgery

  • Blepharitis
  • dacryocystitis
  • chalazion
  • conjunctivitis
  • meibomianitis
  • keratitis
  • corneal ulcer
View approved original text

This medication is effective against various types of bacteria, for example, Staphylococcus, Streptococcus, and Pneumococcus, among others. It is used for inflammatory diseases around the eyes such as blepharitis, dacryocystitis, chalazion, conjunctivitis, meibomianitis, keratitis (including corneal ulcers), etc. It is also utilized as antibacterial therapy before and after ophthalmic surgery to prevent infection. This medicine is very effective in treating ocular inflammation and infections, thereby assisting in the management of ocular diseases.

Dosage and Administration

Adult dosage

Instill (apply) 1 drop per dose, 3 times daily. The dose may be increased or decreased as appropriate according to symptoms.

Precautions

This medication should not be used by patients who have hypersensitivity to quinolone antibiotics or have had an allergic reaction to this medication in the past. If symptoms of shock such as nausea, peripheral coldness, or difficulty in breathing occur while using this medication, usage should be immediately discontinued and proper treatment must be sought. Rarely, symptoms such as cardiovascular collapse, loss of consciousness, swelling of the face or neck, difficulty breathing, rash, and itching may occur; if any of these symptoms arise, the medication should be stopped. Transient burning or irritation, discomfort, redness, itching, tearing, dryness, or blurred vision may occur; in severe cases, serious skin conditions such as keratitis or Stevens-Johnson syndrome may develop, necessitating cessation of use upon noticing such symptoms. Hearing impairment or irritation symptoms may also occur, so caution is advised. To prevent the development of resistant bacteria, when using this medication, it is essential to check the sensitivity of the bacteria and administer it only for the minimum necessary duration. Long-term use can lead to excessive growth of fungi or resistant organisms, hence it is advisable not to use it for extended periods, and if other infections coexist, it is recommended to stop this medication and consider alternative treatments. In the treatment of trachoma, a standard duration of 8 weeks is recommended, and prolonged use afterward should be approached with caution. During treatment, the wearing of soft contact lenses should be avoided, as the preservatives in this medication may cause irritation to the eyes. The safety of this medication during pregnancy has not been established; thus, it should only be used when the benefits to the mother outweigh the risks to the fetus for pregnant women or those who may become pregnant. It is recommended for nursing mothers to either stop breastfeeding or discontinue the use of this medication. The safety and efficacy of this medication have not been confirmed for infants under 1 year of age, so its use is not advised. This medication is an eye-only topical solution, and care should be taken to avoid the tip of the container from directly contacting the eye. Concurrent use poses a risk of contamination, thus it should be avoided whenever possible. When storing, keep it out of reach of children, avoid direct sunlight, and store it in a cool and dry place. Additionally, to prevent misuse and maintain the quality of the medication, it is important not to transfer it to another container.

Side effects

  • Nausea
  • limb coldness
  • difficulty breathing
  • cardiovascular collapse
  • loss of consciousness
  • vascular edema
  • airway obstruction
  • rash
  • urticaria
  • itching
Show 25 more
  • eyelid redness
  • eyelid swelling
  • skin redness
  • conjunctival hyperemia
  • burning sensation
  • irritation
  • discomfort
  • pain
  • redness
  • pruritus
  • chemical conjunctivitis
  • keratitis
  • periorbital edema
  • facial swelling
  • foreign body sensation
  • photophobia
  • blurred vision
  • tears
  • dryness
  • eye pain
  • dizziness
  • obesity-associated superficial keratitis
  • Stevens-Johnson syndrome
  • hearing impairment
  • symptoms of irritation

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

Storage

This medication may be sensitive to air or moisture; thus, it should be stored in a sealed container. Additionally, it is best kept at room temperature between 1 to 30 degrees Celsius, avoiding too hot or too cold conditions. By storing it this way, the effectiveness of the medication can be maintained, and it can be used safely.

Appearance and packaging

Appearance

A transparent liquid of pale yellow to light yellow color contained in a clear 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.

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.