Fluocinolone acetonide (ophthalmic)

FDA label, ANI Pharmaceuticals, Inc., intravitreal, effective 2026-02-19. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Corticosteroid

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Your numbers for fluocinolone acetonide (ophthalmic). Take vial strength, diluent, and limits from the label below.

Basis

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Administer 2-3 drops of a broad-spectrum microbicide into the lower fornix. The lids may be scrubbed with cotton-tipped applicators soaked with a broad-spectrum microbicide. Place a sterile lid speculum. Have the patient look up and apply additional microbicide solution to the injection site. Allow 30-60 seconds for the topical antiseptic to dry prior to injection of YUTIQ.

Contraindications

4. CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1. Ocular or Periocular Infections YUTIQ is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. 4.2. Hypersensitivity YUTIQ is contraindicated in patients with known hypersensitivity to any components of this product.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with YUTIQ have not been conducted in pregnant women to inform drug associated risk. Animal reproduction studies have not been conducted with YUTIQ. It is not known whether YUTIQ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. YUTIQ should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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