Icaft0.25%

Icaft 0.25% ophthalmic solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis, in patients 2 years of age and older.

Icaft 0.25% is not indicated for, and should not be used to treat, eye irritation caused by contact lenses.

Contains Icaft 0.25% 0.25% (2.5 mg/mL) as the active ingredient in a sterile ophthalmic solution.

Icaft 0.25% is a once-daily antihistamine eye drop used to prevent the itching associated with allergic conjunctivitis (allergic eye reactions to pollen, ragweed, grass, dust, or animal dander). Beyond simply blocking histamine receptors, it also has mast-cell-stabilizing properties, giving it a broader preventive effect against the allergic reaction. Because it is a preventive treatment, it works best when used consistently, once daily, rather than only when symptoms are already present, and it should not be used for eye irritation caused by contact lenses, which is a different problem requiring different management.

Therapeutic Class: Ophthalmic Antihistamine

Icaft 0.25% has affinity for both histamine H1 and H2 receptors, with weaker affinity for H4 receptors, and also affects immune cell recruitment and has mast-cell-stabilizing effects, giving it a broader mechanism than a simple antihistamine. Its main circulating metabolite is a carboxylic acid derivative with minimal systemic activity, consistent with the drug's largely localized effect at the eye when used as directed.

• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill 1 drop into each eye
• Avoid touching the dropper tip to the eye, eyelids, or any surface, to prevent contamination and reduce the risk of eye injury
• Keep the bottle tightly closed when not in use
• Remove contact lenses before instillation; they may be reinserted approximately 10-15 minutes after the drop is given
• Do not wear a contact lens if the eye is red, and do not use this product to treat contact lens-related irritation

Systemic absorption from topical ophthalmic use is generally minimal, so significant systemic drug interactions are uncommon. If using additional ophthalmic products, space each one at least 5 minutes apart from Icaft 0.25%.

Common side effects

• Eye irritation, burning, or stinging on instillation
• Eye redness
• Blurred vision (temporary)

Less common effects

• Somnolence (drowsiness) - rare but reported
• Allergic contact dermatitis of the eyelids has been reported in isolated cases with repeated use, presenting as swelling and redness of the eyelids appearing after one or more applications

Serious effects (seek medical attention)

• Signs of a hypersensitivity reaction: swelling of the face or eyelids, widespread rash, difficulty breathing
• Symptoms that worsen instead of improving with use, or new/unusual eye symptoms, which should prompt medical reassessment

Pregnancy

There are no adequate, well-controlled studies of Icaft 0.25% in pregnant women; animal studies with oral administration during organogenesis did not show maternal or embryofetal toxicity at clinically relevant doses, but a potential risk to the fetus and mother cannot be ruled out. Icaft 0.25% should only be used during pregnancy if the potential benefit justifies the potential risk.

Breastfeeding

It is not known whether Icaft 0.25% passes into human milk; use during breastfeeding should be discussed with a healthcare professional.

• Not for contact lens-related irritation: Icaft 0.25% should not be used to treat eye irritation caused by contact lenses; remove lenses before use and do not wear them if the eye is red.
• Eye injury and contamination prevention: avoid touching the dropper tip to the eye, eyelids, or any surface, and keep the bottle tightly closed when not in use.
• May cause temporary blurred vision or drowsiness; use caution with driving or operating machinery if these effects occur.
• If eye symptoms fail to improve, or appear to worsen, with continued use, seek medical reassessment, since an allergic reaction to the product itself (contact dermatitis) has been reported in rare cases.

Topical ophthalmic overdose is unlikely with normal use, given minimal systemic absorption. If accidentally swallowed, contact a doctor or poison control center for advice. Excessive or more frequent use than directed does not improve effectiveness and may increase local irritation.

Store at 15°C to 25°C (59°F to 77°F). Once opened, the product can generally be used until the expiration date printed on the bottle, per the manufacturer's specific instructions.

• Children under 2 years: Safety and efficacy have not been established, and use is not recommended in this age group.
• Children 2 years and older: Established for use at the same dose (1 drop once daily in each eye) as adults.
• Elderly: No specific dose adjustment is generally required.

Icaft 0.25% is generally used throughout the period of expected allergen exposure (such as a pollen season) or on an ongoing basis for perennial (year-round) allergic conjunctivitis, given its preventive rather than purely symptomatic mode of action. If symptoms do not improve within a few days, or worsen, medical reassessment is recommended.

Drug Class: H1 histamine receptor antagonist with mast cell-stabilizing activity

Icaft 0.25% works primarily by blocking histamine H1 receptors in the conjunctiva, preventing histamine (released during an allergic reaction) from producing the characteristic itching, redness, and swelling of allergic conjunctivitis. It also has additional mast-cell-stabilizing activity, helping to reduce the release of histamine and other allergy-triggering substances in the first place, which contributes to its preventive effect when used regularly.

Icaft 0.25% is established for use in children 2 years of age and older, at the same dose (1 drop once daily in each eye) as adults, for prevention of itching associated with allergic conjunctivitis. Safety and efficacy have not been established in children younger than 2 years.