DailyMed Label: HOMATROPINE HYDROBROMIDE OPHTHALMIC

DailyMed Label: HOMATROPINE HYDROBROMIDE OPHTHALMIC

2022

DailyMed Prescription

HOMATROPINE HYDROBROMIDE OPHTHALMIC

Homatropine Hydrobromide

Altaire Pharmaceuticals Inc.

NDC: 59390-192

NDC: 59390-192

Homatropine hydrobromide is an anticholinergic prepared as a sterile topical ophthalmic solution.

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.

For refraction, instill one or two drops topically in the eye(s). May be repeated in five or ten minutes if necessary. For uveitis, instill one or two drops topically up to every three to four hours. Individuals with heavily pigmented irides may require larger doses.

Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.

To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after installation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Excessive topical use of this drug can potentially lead to a confusional state characterized by delirium, agitation, and rarely coma. This state is more apt to occur in the pediatric and geriatric age groups. The specific anti-dote for this systemic anticholinergic syndrome is injectable physostigmine salicylate. Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child’s mouth and to wash their own hands and the child’s hands following administration. Do not touch dropper tip to any surface, as this may contaminate the solution.

Transient symptoms of stinging and burning may occur. Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudates, and an eczematoid dermatitis. Thirst or dryness of mouth, eye irritation not present before therapy, or increased sensitivity of eyes to light may occur.

5mL size in a white plastic bottle 5mL - NDC 59390-192-05 Store at 15° - 30°C (59°- 86°F). Caution: Federal (USA) law prohibits dispensing without prescription. Mfd. by: Altaire Pharmaceuticals, Inc Aquebogue, NY 11931                                                                   R05/13 F# 16545

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). There have been no long-term studies done using homatropine hydrobromide in animals to evaluate carcinogenic potential.

PRINCIPAL DISPLAY PANEL NDC 59390-192-05 Homatropaire Homatropine Hydrobromide Ophthalmic Solution, USP 5% 5 mL- Sterile Rx Only NDC 59390-192-05 Homatropaire Homatropine Hydrobromide Ophthalmic Solution, USP 5% 5 mL- Sterile Rx Only