KETA EYE DROPS 5 ML

Indications

Approved Uses

Treatment/prevention (relief) of ocular itching associated with allergic conjunctivitis (seasonal and perennial).

Off-Label Uses

Adjunctive use in other allergic ocular conditions (e.g., vernal keratoconjunctivitis) may be used in practice, but it is not a primary labeled indication.

Dosage & Administration

Dosing by Condition

Allergic conjunctivitis (adults and children ≥3 years): instill 1 drop in the affected eye(s) twice daily (every 8-12 hours).

Initial Dose

1 drop in affected eye(s) twice daily

Maintenance Dose

1 drop in affected eye(s) twice daily

Maximum Dose

1 drop in the affected eye(s) twice daily (approximately every 8-12 hours).

Children's Dosage

Children ≥3 years: 1 drop in affected eye(s) twice daily (same as adult dose). Not recommended for children under 3 years.

Dose Adjustment Notes

No dose adjustment is generally required in renal or hepatic impairment for ophthalmic ketotifen due to minimal systemic absorption.

How to Take

Wash hands. Tilt head back, pull down the lower eyelid to form a pocket, instill 1 drop into the conjunctival sac without touching the dropper tip. Close the eye gently for 1-2 minutes and apply nasolacrimal occlusion (press inner corner). If using other ophthalmic products, separate by at least 5 minutes; remove soft contact lenses before use and reinsert after ~15 minutes (especially if preserved with benzalkonium chloride).

Side Effects

Common Side Effects

Transient eye burning/stinging or irritation, conjunctival hyperemia, dry eye, eye pain, eyelid disorders, eye discharge; headache and rhinitis can occur; photophobia is less common.

Side Effect Frequency

Common: transient eye burning/stinging/irritation after instillation; may also include headache and dry eye. Uncommon: blurred vision, photophobia, eyelid edema/disorder, conjunctival reactions (e.g., conjunctivitis/injection), and hypersensitivity reactions (rash/urticaria).

Safety & Warnings

Contraindications

Hypersensitivity to ketotifen or to any excipient in the formulation (e.g., benzalkonium chloride if present).

Warnings & Precautions

Contains preservative (commonly benzalkonium chloride): remove soft contact lenses before use and wait at least 10-15 minutes before reinsertion; do not use to treat contact lens-related irritation; avoid contaminating the dropper tip; for ophthalmic use only (not oral/injectable).

Age Restriction

Not recommended in children <3 years (safety/efficacy not established); may be used ≥3 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

No clinically significant interactions expected with ophthalmic ketotifen due to minimal systemic absorption; if using other eye medicines, separate administrations by at least 5 minutes.

Interaction Severity

No clinically significant systemic drug interactions are expected with ophthalmic ketotifen; key practical interaction is with soft contact lenses (benzalkonium chloride preservative may be absorbed by lenses-remove before use).

Food Interaction

No clinically relevant food interactions (not applicable for ophthalmic use).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children ≥3 years: 1 drop in affected eye(s) twice daily (same as adult dose). Not recommended for children under 3 years.

Elderly

Standard adult dosing.

Kidney Impairment

Not applicable for ophthalmic use; no renal dose adjustment is recommended.

Liver Impairment

Not applicable for ophthalmic use; no hepatic dose adjustment is recommended.

Storage & Patient Advice

Stopping the Medicine

May be stopped when symptoms resolve; no taper is required.

Patient Counseling

For allergic conjunctivitis: instill 1 drop in the affected eye(s) twice daily (about every 8-12 hours) or as directed. Remove contact lenses before use and wait at least 10-15 minutes before reinserting (do not use while lenses are in place if eyes are red/irritated). Avoid touching the dropper tip to the eye/skin/surfaces; recap tightly. Temporary burning/stinging or blurred vision may occur-use caution with driving until vision clears. Seek medical advice/stop and consult if eye pain, marked redness, vision changes, or symptoms worsen or do not improve within ~72 hours. Discard the bottle 4 weeks after opening (standard for multidose ophthalmic drops unless the product leaflet states otherwise).

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Dual-acting antiallergic: H1-receptor antagonist and mast cell stabilizer that inhibits release of mediators (e.g., histamine, leukotrienes) in the conjunctiva.

Onset of Action

Within minutes for itch relief; mast-cell stabilizing benefit is enhanced with regular use over days.

Duration of Effect

Approximately 8-12 hours per dose (often described as up to 12 hours).

Bioavailability

Ophthalmic: low systemic absorption (systemic bioavailability is minimal/clinically insignificant).

Product Information

Available Dosage Forms

Eye drops (ophthalmic solution) only for this product (KETA 5 mL).

Composition per Dose

Each mL: Ketotifen 0.025% (0.25 mg) as ketotifen fumarate

Generic Availability

Yes

OTC Alternatives

Olopatadine ophthalmic, azelastine ophthalmic, levocabastine ophthalmic (availability varies by country/OTC status).

Target Organ

Eye

Preservative Free

No

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