"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 ZIOPTAN in the conjunctival sac of the affected eye(s) once daily in the evening.
Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.
ZIOPTAN may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.
The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Dosage Forms And Strengths
Ophthalmic solution containing tafluprost 0.015 mg/mL.
Storage And Handling
ZIOPTAN (tafluprost ophthalmic solution) 0.0015% is supplied as a sterile solution in translucent low density polyethylene single-use containers packaged in foil pouches (10 single-use containers per pouch). Each single-use container has 0.3 mL solution corresponding to 0.0045 mg tafluprost.
NDC 0006-3931-30; Unit-of-Use Carton of 30.
NDC 0006-3931-54; Unit-of-Use Carton of 90.
Store refrigerated at 2-8°C (36-46°F). Store in the original pouch. After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 28 days at room temperature: 2025°C (68-77°F). Protect from moisture. Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 28 days after first opening the pouch.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Laboratoire Unither ZI de la Guerie F-50211 COUTANCES Cedex France . Revised: 2012
Last reviewed on RxList: 2/27/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Zioptan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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