Medication info

Ketotifen Ophthalmic Solution (Ketotifen Fumarate)

OTC medicationApproval withdrawn
Ingredient · strength
Ketotifen Fumarate›Strength being verified
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
A clear, colorless or pale yellow transparent eye drop solution in a clear plastic container.
Packaging
5mL/bottle
Approval status
Approval withdrawn

MFDS item code 201901317 · Notified 2019.03.04

This product's status changed to Approval withdrawn on 2023.07.19.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 allergic conjunctivitis
Who uses it
Adults · Children
Adult dosage
Adults: Instill 1 drop at a time, 2-4 times daily, or as appropriate depending on the condition.
Children's dosage
Infants and children: Follow the physician's prescription.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

Treatment of allergic conjunctivitis

  • Allergic conjunctivitis
View approved original text

This medication is used for allergic conjunctivitis.

Dosage and Administration

Adult dosage

Adults: Instill 1 drop at a time, 2-4 times daily, or as appropriate depending on the condition.

Children's dosage

Infants and children: Follow the physician's prescription.

Precautions

This medication should not be used by individuals who are allergic to any of its components, or by children under 1 year of age. It is advisable not to use this medication concurrently with other eye drops, especially those that depress the central nervous system, antihistamines, or alcohol, as their effects may be enhanced. Caution is advised when taken with oral diet medications, as there is a risk of reducing platelet count. Since this medication may cause blurred vision after application, it is safe to avoid driving or operating machinery until vision clears. Rarely, drowsiness or sedation may occur; if these symptoms manifest, driving or hazardous tasks should also be avoided. Do not use this medication without consulting a doctor, dentist, or pharmacist, especially if currently undergoing treatment or allergy therapy, if there is a history of drug allergies, or if pregnant or breastfeeding, as it is essential to seek professional advice. If redness, irritation, or itching persists in the eyes or if eyelid inflammation occurs, discontinue use immediately and consult a professional. If symptoms do not improve or worsen, stop using this medication and consult with a doctor or pharmacist. Temporary burning, redness, swelling, or itching may occur upon using this medication, so caution is required if these symptoms arise. The prescribed dosage and frequency must be strictly followed, and this medication is for ocular use only. Be careful not to let the tip of the container touch the eyelids or eyelashes, and do not use if the solution appears contaminated or cloudy. Avoid sharing this medication as it may increase the risk of contamination. When using with other eye drops, a minimum interval of more than 5 minutes should be maintained between applications. If this medication is accidentally swallowed, the amount is much less than the usual oral dosage, so there is little concern for overdose. The preservatives contained in this medication may adhere to soft contact lenses, so it should not be used while wearing lenses; wear lenses only after at least 15 minutes post-application. This medication should be stored between 15 to 25 degrees Celsius and used within 4 weeks after opening. Store out of reach of children in the original container with the lid tightly closed. Transferring to another container may reduce the quality of the medication or risk misuse, so caution is advised.

Side effects

  • blurred vision
  • drowsiness
  • sedative effects
  • redness of the eyes
  • irritation
  • itching
  • blepharitis
  • eyelid dermatitis
  • burning sensation
  • swelling
Show 1 more
  • local irritation

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, preferably at room temperature between 15 to 25 degrees Celsius. This storage helps maintain the efficacy of the medication for a longer duration and prevents degradation.

Appearance and packaging

Appearance

A clear, colorless or pale yellow transparent eye drop solution in a clear plastic container.

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

No questions yet.

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.