Drug Catalog - Product Detail
APRACLONIDINE HCL OPHTH. SOLUTION SOL 0.005 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0716-11 | AKORN | 10 | 0.5% | SOLUTION |
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Description
DESCRIPTION Apraclonidine Ophthalmic Solution, USP 0.5% as base contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4-amino-2,6 dichlorophenyl) imino]imidazolidine monohydrochloride with an empirical formula of C 9 H 11 Cl 3 N 4 and a molecular weight of 281.57. The chemical structure of apraclonidine hydrochloride is: Each mL of Apraclonidine Ophthalmic Solution, USP 0.5% as base contains: Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg; Inactives: sodium acetate, sodium chloride, sodium hydroxide and/or hydrochloric acid may be added to adjust pH (4.4 to 7.8) and water for injection; Preservative: benzalkonium chloride 0.01%. Chemical Structure
How Supplied
HOW SUPPLIED Apraclonidine Ophthalmic Solution, USP 0.5% as base in a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied in a white plastic LDPE ophthalmic bottle with a natural LDPE controlled dropper tip and a purple polypropylene cap as follows: 5 mL NDC 17478-716-10 10 mL NDC 17478-716-11 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and light. Retain in carton until time of use. Rx Only AKORN Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 AC00N Rev. 01/22
Indications & Usage
INDICATIONS AND USAGE Apraclonidine Ophthalmic Solution, USP 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. Patients on maximally tolerated medical therapy who are treated with Apraclonidine Ophthalmic Solution, USP 0.5% as base to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The addition of Apraclonidine Ophthalmic Solution, USP 0.5% as base to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because Apraclonidine Ophthalmic Solution, USP 0.5% as base is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of Apraclonidine Ophthalmic Solution, USP 0.5% as base diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.
Dosage and Administration
DOSAGE AND ADMINISTRATION One to two drops of apraclonidine ophthalmic solution should be instilled in the affected eye(s) three times daily. Since apraclonidine ophthalmic solution will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. NOT FOR INJECTION INTO THE EYE. NOT FOR ORAL INGESTION.