(Atropine) Homatropaire Homatropine 5% 5mL Ophthalmic Solution

NDC: 59390-192-05

Homatropine Hydrobromide 5% Ophthalmic Solution, 5 mL — Altaire Pharmaceuticals

Indications and Usage

Indicated as a moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. Also used for pre- and postoperative mydriasis and as an optical aid in certain cases of axial lens opacities.

Dosage and Administration

For refraction, instill one or two drops topically in the eye, repeated in five to ten minutes if necessary. In the treatment of uveitis, instill one or two drops up to every three or four hours as needed; heavily pigmented irides may require larger or more frequent doses.

Warnings and Precautions

• For topical ophthalmic use only; not for injection
• Use with caution in infants, young children, and elderly patients due to the risk of systemic atropine-like toxicity
• Use with caution in patients with keratoconus and in individuals with Down syndrome, who may show increased susceptibility
• May cause temporary blurred vision and light sensitivity; patients should avoid driving or hazardous activities until vision clears

Contraindications

Contraindicated in patients with primary glaucoma or a tendency toward glaucoma, in those with narrow anterior chamber angles, and in patients with hypersensitivity to any component of the product.

Adverse Reactions

Transient stinging and burning may occur on instillation. Prolonged use may produce local irritation with follicular conjunctivitis, vascular congestion, edema, exudate, and eczematoid dermatitis, along with dryness and photophobia.

Storage and Handling

Store at 15°C to 30°C (59°F to 86°F).

How Supplied

Supplied as a sterile ophthalmic solution in a 5 mL plastic dropper bottle.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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