FOR TOPICAL OPHTHALMIC USE ONLY – NOT FOR INJECTION. Risk-benefit should be considered when the following medical problems exist: keratoconus (homatropine may produce fixed dilated pupil); Down’s syndrome, children with brain damage and the elderly (increased susceptibility). In infants and small children, use with extreme caution.
There is currently no manufacturer warning information available for this drug.
A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. For pre- and postoperative states when mydriasis is required. Use as an optical aid in some cases of axial lens opacities.
ISOPTO® Homatropine (homatropine hydrobromide ophthalmic solution) is an anticholinergic prepared as a sterile topical ophthalmic solution supplied in two strengths. The active ingredient is represented by the chemical structure:
Established name: Homatropine Hydrobromide
Chemical name: Benzeneacetic acid, α-hydroxy-, 8-methyl-8-azabicyclo[3.2.1]-oct-3-yl ester, hydrobromide, endo-(±)-.
Each mL contains: Active: homatropine hydrobromide 2.0% or 5.0%. Preservatives: benzalkonium chloride 0.01% in 2% strength, benzethonium chloride 0.005% in 5% strength. Vehicle: hypromellose 0.5%. Inactives: sodium chloride, polysorbate 80 (in 2% strength), sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
