Generic Name

Ketotifen Fumarate

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Classification

FDA Approved Indications

• Relief of allergic conjunctivitis symptoms such as itching, redness, and swelling

Mechanism of Action

Ketotifen Fumarate inhibits the release of allergic mediators from mast cells and blocks H1 histamine receptors, reducing allergic symptoms.

Dosage and Administration

Adult: 1 drop in affected eye(s) twice daily, approximately 8-12 hours apart

Pediatric: Age 3 years and older: 1 drop in affected eye(s) twice daily; not recommended for children under 3 years

Geriatric: No specific dose adjustments necessary, use with caution as with other medications

Renal Impairment: No specific dosing adjustments established; use cautiously

Hepatic Impairment: No specific dosing adjustments established

Pharmacokinetics

Absorption: Limited systemic absorption when used topically

Distribution: Primarily local in eye tissues

Metabolism: Metabolized minimally; mostly remains localized

Excretion: Excreted in urine; systemic absorption is minimal

Half Life: Approximately 3 hours systemically, but topical ocular half-life not well-defined

Contraindications

• Hypersensitivity to ketotifen or other components

Precautions

• Use with caution in patients with active ocular infections or recent ocular surgery; for use in children only if above 3 years

Adverse Reactions - Common

• Ocular irritation or stinging (Common)
• Redness (Common)

Adverse Reactions - Serious

• Eye pain or sensitivity to light (Rare)
• Visual disturbances (Rare)
• Allergic reactions such as swelling or rash (Rare)

Drug-Drug Interactions

• No significant interactions reported with ocular use

Drug-Food Interactions

• No known interactions

Drug-Herb Interactions

• No known interactions

Nursing Implications

Patient/Family Teaching

• Use medication exactly as prescribed.
• Do not touch dropper tip to eye or skin to avoid contamination.
• Report any eye pain, changes in vision, or persistent irritation.

Special Considerations

Black Box Warnings:

• None

Genetic Factors: None specific

Lab Test Interference: No known interference

Overdose Management

Signs/Symptoms: If ingested in large amounts, systemic effects such as drowsiness or agitation may occur

Treatment: Supportive care; activated charcoal if ingestion is recent; seek immediate medical attention

Storage and Handling

Storage: Store at room temperature, away from light and moisture

Stability: Stable until printed expiration date when stored properly