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Fluomoline Eye Drops

NAFDAC Reg.-Nr. B4-7862 Medikament

Registriert bei NAFDAC. Registrierung aktivAs of 5 November 2026 · synced automatically from official sources.
Produkt-
Fluomoline Eye Drops
NAFDAC-Nummer
B4-7862
Wirkstoff
Fluorometholone; Tetryzoline Hydrochloride
Stärke
0.1%; 0.025%
Form
Eye drops
VPE:
1 x 5 mL (in plastic bottle)
Hersteller
Nicht aufgeführt
Applicant (holder)
Lin-Kabs Pharmaceutical Limited
Approved
6 Jul 2023
Status
Active View on NAFDAC ↗
Registration valid to
5 Jul 2028
WER WARNT
None found
Community reports
None
Times checked
0

About the medicine: Fluorometholone: uses, dosage and brands worldwide

What we found

  • Fluomoline Eye Drops is on the NAFDAC register with an active registration (B4-7862). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

How to use Fluomoline Eye Drops

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

How to take it and how often
  • Shake well before using
  • Instill one drop into the conjunctival sac two to four times daily
  • During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours
  • Care should be taken not to discontinue therapy prematurely
  • If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS )
  • The dosing of fluorometholone ophthalmic suspension 0.1% may be reduced, but care should be taken not to discontinue therapy prematurely
  • In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications
Children

Safety and effectiveness in infants below the age of two years have not been established.

Older adults

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

While you are taking it
  • If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician
  • This product is sterile when packaged
  • To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface
  • The use of this bottle by more than one person may spread infection
  • Keep bottle tightly closed when not in use
  • Keep out of the reach of children
  • The preservative in fluorometholone ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses. …
Talk to a doctor first if
  • Fluorometholone ophthalmic suspension 0.1% is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures
  • Fluorometholone ophthalmic suspension 0.1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids
Warnings

Prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. …

Possible side effects

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. …

Pregnancy and breastfeeding

Pregnancy Teratogenic effects Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were o …

How to store it

Storage: Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised : 12/20 23 For more information, call 1-800-678-1605 Distributed for: AbbVie Inc. North Chicago, IL 60064 © 2023 AbbVie. All rights reserved. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2023-12-01.

Label for fluorometholone and tetryzoline hydrochloride, the active ingredient registered with NAFDAC.

Check your pack of Fluomoline Eye Drops

Add the expiry date on your pack for a full Trust Score.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

About Fluomoline Eye Drops

What is in Fluomoline Eye Drops?

Fluomoline Eye Drops contains Fluorometholone; Tetryzoline Hydrochloride (0.1%; 0.025%), as eye drops, according to its NAFDAC registration record.

Is Fluomoline Eye Drops registered with NAFDAC?

Yes. Fluomoline Eye Drops is listed on the NAFDAC register under registration number B4-7862, and its registration is active as of 5 November 2026.

Has Fluomoline Eye Drops been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Fluomoline Eye Drops in our automatically synced alert list.

How can I check that my pack of Fluomoline Eye Drops is genuine?

Run a free authenticity scan with the NAFDAC number B4-7862, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

How do I take Fluomoline Eye Drops?

Follow your prescription or the leaflet in your pack. The official label says: Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dos…

What is Fluomoline Eye Drops used for?

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. (Summarised from the official U.S. FDA label for fluorometholone and tetryzoline hydrochloride. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.