Drug Catalog - Product Detail
APRACLONIDINE HCL OPHTH. SOLUTION SOL 0.005 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 61314-0665-05 | SANDOZ | 5 | 0.5% | NA |
PACKAGE FILES
Generic Name
APRACLONIDINE
Substance Name
APRACLONIDINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
NDA020258
Description
DESCRIPTION Apraclonidine ophthalmic solution 0.5% 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 g/mol. The chemical structure of apraclonidine hydrochloride is: Each mL of apraclonidine ophthalmic solution 0.5% contains: Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, sodium acetate, and sodium chloride. image
How Supplied
HOW SUPPLIED Apraclonidine ophthalmic solution 0.5% as base in a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied in plastic ophthalmic dispenser as follows: 5 mL NDC 61314-665-05 10 mL NDC 61314-665-10 Storage: Store between 2° to 25°C (36° to 77°F). Protect from freezing and light. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indications & Usage
INDICATIONS AND USAGE Apraclonidine ophthalmic solution 0.5% 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 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% 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 0.5% 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 0.5% 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 0.5% should be instilled in the affected eye(s) three times daily. Since apraclonidine ophthalmic solution 0.5% 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.