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DOSAGE AND ADMINISTRATION
The recommended dose is one drop instilled into each affected eye twice a day.
OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is supplied as follows:
OPTIVAR (azelastine hydrochloride) ® 6 mL (NDC#0037-7025-60) solution in a translucent 10 mL HDPE container with a LDPE dropper tip and a white HDPE screw cap.
OPTIVAR (azelastine hydrochloride) ® 0.2 mL (NDC#0037-7025-01) solution in a translucent 1 mL HDPE single-use container, packaged as 4 single-use containers in a foil pouch in a carton.
Once OPTIVAR (azelastine hydrochloride) ® 0.2 mL unit dose foil pouch is open, unopened containers can be used for one month, not to exceed the expiration date imprinted on the container. After one month they should be discarded. Use only if foil pouch is sealed and single container is intact. Discard each container immediately after use.
OPTIVAR (azelastine hydrochloride) ® 6 mL container: Store UPRIGHT between 2° and 25°C (36°
OPTIVAR (azelastine hydrochloride) ® 0.2 mL container: Store at controlled room temperature 20°-25°C (68° -77°F).
OPTIVAR (azelastine hydrochloride) ® 6 mL container Manufactured by: Patheon UK Ltd., Swindon, United Kingdom. OPTIVAR (azelastine hydrochloride) ® 0.2 mL container Manufactured by: Catalent Pharma Solutions, Woodstock, Illinois, USA. Distributed by: Meda Pharmaceuticals™, Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120. OPTIVAR (azelastine hydrochloride) ® 6 ml container Made in United Kingdom. OPTIVAR (azelastine hydrochloride) ® 0.2 mL Made in United States. Issued 06/2008. FDA revision date: 07/02/08
Last reviewed on RxList: 8/5/2008
This monograph has been modified to include the generic and brand name in many instances.
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