Apraclonidine Ophthalmic Solution 0.5% 5mL

NDC: 61314-665-05

Apraclonidine HCl 0.5% Ophthalmic Solution, 5 mL — Sandoz

Active ingredient	Apraclonidine hydrochloride equivalent to 5 mg apraclonidine base per mL (0.5%)
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Sandoz
NDC	61314-665-05

Indications and Usage

Short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional reduction of intraocular pressure.

Dosage and Administration

Instill one to two drops in the affected eye(s) three times daily. Patients using the drug to control intraocular pressure should be monitored for a possible loss of effect over time.

Warnings and Precautions

• For topical ophthalmic use only; not for injection or oral use
• Use caution in patients with severe cardiovascular disease including hypertension
• Use caution in patients with renal or hepatic impairment
• Loss of intraocular-pressure-lowering effect (tachyphylaxis) may occur over time

Contraindications

Contraindicated in patients hypersensitive to apraclonidine or clonidine and in patients receiving monoamine oxidase inhibitors.

Adverse Reactions

The most common adverse reactions are ocular hyperemia, pruritus, discomfort, tearing, and lid edema, along with dry mouth; allergic-like ocular reactions are the most frequent cause of discontinuation.

Storage and Handling

Store at 2°C to 25°C (36°F to 77°F); protect from freezing and from light.

How Supplied

Sterile 0.5% solution in plastic dropper dispenser bottles, supplied in 5 mL and 10 mL sizes.

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.

If you have any questions related to DSCSA compliance, transaction history, regulatory data or quality assurance, please contact our team at compliance@dryeyerescue.com for more information.