Mast Cell Stabilizer; Ophthalmic Agent, Miscellaneous

Prevent itching of the eye due to allergic conjunctivitis

C

There are no adequate and well-controlled studies in pregnant women. Should only be used during pregnancy if the benefit outweighs the risk to the fetus. It is not known if pemirolast potassium is excreted in human milk; caution should be used if administered to a breast-feeding woman.

Hypersensitivity to pemirolast or any component

Safety and efficacy in children <3 years of age have not been established; not for injection or oral use; ophthalmic use only; not indicated to treat contact lens irritation; do not wear contact lens if eye is red. In non-red eyes, soft contact lenses should not be applied for 10 minutes after the instillation of pemirolast potassium to avoid absorption of lauralkonium chloride (a preservative in Alamast™).

>10%:

Central nervous system: Headache (10% to 25%)

Respiratory: Rhinitis (10% to 25%)

Miscellaneous: Cold/flu symptoms (10% to 25%)

<5%:

Central nervous system: Fever

Endocrine & metabolic: Dysmenorrhea

Ocular: Burning eyes, dry eyes, foreign body sensation, ocular discomfort

Neuromuscular & skeletal: Back pain

Respiratory: Bronchitis, cough, sinusitis, sneezing/nasal congestion

No reports of overdose. A 10 mL bottle is equal to 10 mg of pemirolast potassium if ingested orally.

None reported

Store at room temperature, 15°C to 25°C (59°F to 77°F)

Mast cell stabilizer that inhibits the in vivo type I immediate hypersensitivity reaction; in addition, inhibits chemotaxis of eosinophils into the ocular tissue and blocks their release of mediators; also reported to prevent calcium influx into mast cells following antigen stimulation

Onset: Within a few days

Peak effect: 4 weeks

Absorption: Systemically absorbed after ophthalmic administration

Half-life: 4.5 hours

Elimination: 10% to 15% of a topical dose is excreted unchanged in the urine

Children >3 years and Adults: 1-2 drops instilled in affected eye(s) 4 times/day

No information available to require special precautions

No effects or complications reported

Decreased itching may occur within a few days, however, longer treatment (up to 4 weeks) is frequently required. Do not use to treat contact lens irritation; do not wear contact lenses if eyes are red. Soft contact lens wearers using pemirolast in non-red eyes should wait at least 10 minutes after application before inserting contact lenses to avoid absorption of the preservative, lauralkonium chloride. In order to prevent contamination, do not allow the dropper tip to touch the eyelid or surrounding areas. When not in use, keep bottle tightly closed.

Solution, ophthalmic: 0.1% (10 mL)