Pemirolast Potassium

• Allergic Conjunctivitis:
  For the prevention and treatment of ocular itching associated with seasonal allergic conjunctivitis.
• Off-label Uses:
  Occasionally used for vernal keratoconjunctivitis and other allergic eye conditions.

• Route: Ophthalmic solution (eye drops).
• Adults and children ≥3 years:
  Instill 1 drop into the affected eye(s) 4 times daily.
• Duration: Continue during allergy season or as prescribed by physician.
• Special populations:
  Safety and efficacy in children under 3 years have not been established. No dosage adjustments required for elderly.

Pemirolast potassium is a selective mast cell stabilizer. It inhibits degranulation of sensitized mast cells, thereby preventing the release of histamine and other pro-inflammatory mediators responsible for allergic symptoms such as itching, redness, and swelling in ocular tissues.

• Absorption: Minimal systemic absorption following ocular administration.
• Distribution: Localized primarily to the conjunctival tissues.
• Metabolism: Not significantly metabolized due to negligible systemic absorption.
• Elimination: Any absorbed drug is excreted unchanged via the kidneys.
• Onset: Symptom relief may begin within hours; maximal effect develops after several days.

• Pregnancy: FDA Pregnancy Category C. Animal studies show no direct fetal harm, but human data are insufficient; use only if clearly needed.
• Lactation: Data unavailable; use with caution during breastfeeding.

• Mast cell stabilizer
• Antiallergic ophthalmic agent

• Hypersensitivity to pemirolast potassium or any component of the formulation.

• Avoid use in patients with ocular infections.
• Avoid contamination of the dropper tip to prevent infections.
• Discontinue if eye irritation, pain, or worsening of symptoms occurs and consult a healthcare professional.
• Remove contact lenses before administration; lenses may be reinserted 15 minutes after dosing.

• Common: Mild ocular irritation, burning, stinging, conjunctival hyperemia.
• Rare: Blurred vision, dry eyes, headache, hypersensitivity reactions.
• Most side effects are mild and transient, typically occurring shortly after instillation.

• No clinically significant drug interactions reported due to minimal systemic absorption.
• When used with other ophthalmic drugs, separate administration by at least 5 minutes.

• No major recent changes in labeling or dosing recommendations.
• Continued endorsement as a safe alternative to topical antihistamines for allergic conjunctivitis.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and excessive heat.
• Keep container tightly closed when not in use.
• Do not freeze.
• Discard 4 weeks after opening to prevent contamination.