Overdose : מינון יתר

11      OVERDOSAGE
Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving ALPHAGAN® P as part of medical treatment of congenital glaucoma or by accidental oral ingestion (see USE IN SPECIFIC POPULATIONS, 10.3). Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

12      DESCRIPTION
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) , sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent).

The structural formula of brimonidine tartrate is:



5- Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 
In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 6.9-7.4

Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.

ALPHAGAN® P contains the active ingredient brimonidine tartrate 0.15% w/v with the inactive ingredients sodium chloride; sodium carboxymethylcellulose; boric acid; potassium chloride; sodium borate decahydrate; calcium chloride dihydrate; magnesium chloride hexahydrate; Purite® (stabilized oxychloro complex, 2% sol) 0.005% (0.05mg/mL) as a preservative; hydrochloric acid and/or sodium hydroxide to adjust pH and purified water.