"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
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DOSAGE AND ADMINISTRATION
The recommended dose is one drop of ALPHAGAN® P (brimonidine tartrate) in the affected eye(s) three times daily, approximately 8 hours apart. ALPHAGAN® P (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.
Dosage Forms And Strengths
Solution containing 1 mg/mL or 1.5 mg/mL brimonidine tartrate.
Storage And Handling
ALPHAGAN® P (brimonidine tartrate) is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle NDC 0023-9321-05
10 mL in 10 mL bottle NDC 0023-9321-10
15 mL in 15 mL bottle NDC 0023-9321-15
5 mL in 10 mL bottle NDC 0023-9177-05
10 mL in 10 mL bottle NDC 0023-9177-10
15 mL in 15 mL bottle NDC 0023-9177-15
Storage: Store at 15° - 25°C (59° - 77°F).
Allergan, Inc. Irvine, CA 92612, U.S.A. Revised: 05/2010
Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Alphagan-P Information
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Report Problems to the Food and Drug Administration
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