Drug Catalog - Product Detail
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOL 0.002 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 61314-0143-10 | SANDOZ | 10 | 0.2% | SOLUTION |
PACKAGE FILES
Generic Name
BRIMONIDINE TARTRATE
Substance Name
BRIMONIDINE TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA076254
Description
11 DESCRIPTION Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5. The structural formula is: In solution, brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. Each mL of brimonidine tartrate ophthalmic solution, 0.2% contains: Active ingredient: brimonidine tartrate: 0.2% (2 mg/mL). Preservative: benzalkonium chloride (0.05 mg). Inactives: citric acid; polyvinyl alcohol; sodium chloride; sodium citrate; and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. chemical
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution, 0.2% is supplied sterile in white opaque LDPE plastic dropper bottles with tips with purple polypropylene caps as follows: 5 mL in 8 mL bottle NDC 61314-143-05 10 mL in 10 mL bottle NDC 61314-143-10 15 mL in 15 mL bottle NDC 61314-143-15 NOTE: Store between 15° to 25°C (59° to 77°F).
Indications & Usage
1 INDICATIONS AND USAGE Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored. Brimonidine tartrate ophthalmic solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of brimonidine tartrate ophthalmic solution, 0.2% in the affected eye(s) three times daily, approximately 8 hours apart. Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s), three times daily, approximately 8 hours apart. ( 2 )