Medication info

Fluorometholone and Tetrahydrozoline Ophthalmic Solution

Prescription medicationSuspension점안Expired
Ingredient · strength
Fluorometholone›1mg / 1mLTetrahydrozoline Hydrochloride›0.25mg / 1mL
Manufacturer / importer
(주)아리제약
Appearance
Colorless to pale yellow suspension in a colorless transparent bottle
Packaging
5 milliliters / bottle, 6 milliliters / bottle
Approval status
Expired

MFDS item code 201908505 · Notified 2019.12.18

This product's status changed to Expired on 2024.12.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of inflammation in acute non-infectious conjunctivitis (edema, hyperemia) and anterior segment inflammation (such as anterior uveitis) and post-surgical inflammation
Who applies the drops
Adults
Adult eye dose
Instill 1 drop into the conjunctival sac 2-3 times a day. In adults, during the first 24-48 hours, 1 drop may be instilled every hour.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Relief of inflammation in acute non-infectious conjunctivitis (edema, hyperemia) and anterior segment inflammation (such as anterior uveitis) and post-surgical inflammation

  • Severe edema
  • hyperemia
  • acute non-infectious conjunctivitis
  • allergic keratitis
  • non-infectious inflammation in the anterior segment
  • anterior uveitis
  • episcleritis
  • scleritis
  • inflammation after strabismus surgery
  • inflammation after cataract surgery
  • inflammation after glaucoma surgery
View approved original text

This medication is used to treat acute non-infectious conjunctivitis with severe edema and hyperemia, allergic keratitis, and non-infectious inflammation in the anterior segment such as anterior uveitis, episcleritis, scleritis, as well as inflammation occurring after strabismus surgery, cataract surgery, and glaucoma surgery.

How to apply drops

Adult eye dose

Instill 1 drop into the conjunctival sac 2-3 times a day. In adults, during the first 24-48 hours, 1 drop may be instilled every hour.

Precautions

This medication is for ophthalmic use only and should not be used by certain patients. For example, those allergic to any of its components, pregnant or breastfeeding women should avoid using it. It is also not recommended for those with infectious keratitis or conjunctivitis, glaucoma patients, and those with dry eye, especially with Sjögren's syndrome. Patients with corneal damage or ulcers, viral, bacterial, or fungal infections, and children under 2 years old should not use this medication. This medication should be used cautiously in individuals with specific conditions. Patients with coronary heart disease, severe hypertension, severe blood circulation disorders, hyperthyroidism, or diabetes need to exercise caution. Patients taking MAO inhibitors or medications that may raise blood pressure should also be careful. It requires cautious administration for people with a history of cataracts, herpes simplex infections, or dry rhinitis, as well as for infants and children. Temporary irritation symptoms may appear in the eyes after using this medication, and prolonged use may lead to increased intraocular pressure, thus regular intraocular pressure testing is necessary. Furthermore, prolonged use could rarely trigger allergic reactions such as ocular hyperemia, dermatitis, and punctate keratitis. There is also a risk of cataract or corneal defects with long-term use of corticosteroids. Fungal infections could develop in the eye tissue, wound healing may be delayed, and other rare complications such as mydriasis, psoriasis, exophthalmos, or nutritional corneal damage may emerge. Serious side effects such as posterior capsule cataracts, corneal thinning, and perforation of the eyeball may also occur. Particularly in children, prolonged use might lead to systemic side effects such as headaches or insomnia, so caution is necessary. While using this medication, it is recommended to avoid wearing soft contact lenses and not to use it for long periods. If used for more than 2-3 days, intraocular pressure, systemic side effects, and signs of secondary infections should be regularly monitored. Persistent corneal ulcers may warrant suspicion of fungal infection. This medication may conceal or exacerbate eye infections and caution is warranted as it may also mask allergic reactions. Temporary blurriness may occur after eye drops are administered; thus, driving or operating hazardous machinery should be avoided until vision becomes clear. It is safest not to use this medication in conjunction with MAO inhibitors or tricyclic antidepressants that may elevate blood pressure. Also, when combined with CYP3A4 inhibitors, increased systemic exposure may elevate the risk of side effects, so it should only be used carefully when absolutely necessary. Safety in infants and children has not been fully established, and there is a risk of systemic side effects, hence it should be administered cautiously. Overdosing may lead to severe symptoms, so immediate emergency treatment is necessary in the case of oral administration. Before use, the solution should be shaken well, and it is for ophthalmic use only; care must be taken to avoid contact between the opening of the container and the eye. Co-use is discouraged due to the risk of contamination. When storing, it should be kept in a tightly sealed container to avoid exposure to air or moisture. Maintaining a storage temperature between 15 degrees and 25 degrees Celsius at room temperature is essential to prolong the efficacy of the medication.

Side effects and when to seek care immediately

Serious side effects

Increased intraocular pressure, allergic reactions in the form of eyelid dermatitis (including hives and severe swelling), secondary infections from fungi, cataracts and corneal defects (corneal damage), eyeball perforation, headaches (potential severe neurological symptoms), elevated blood pressure (possibly accompanied by swelling), severe allergic reactions, serious skin adverse reactions, severe swelling with elevated blood pressure.

Mild side effects

Transient mild irritation symptoms immediately after application, increased intraocular pressure, reactive hyperemia, allergic reaction in the form of eyelid dermatitis, punctate keratitis, periorbital dermatitis, cataracts, corneal defects, secondary infections from fungi, delayed wound healing, mydriasis, psoriasis, exophthalmos, nutritional corneal damage, posterior capsule cataracts, corneal thinning, eyeball perforation, headaches, insomnia, temporary blurred vision

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 15 to 25 degrees Celsius at room temperature. This helps prolong the medication's effectiveness.

Appearance and packaging

Appearance

Colorless to pale yellow suspension in a colorless transparent bottle

Package unit

5 milliliters / bottle, 6 milliliters / 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.

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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.