"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
VIRA-A (vidarabine) Ophthalmic Ointment, 3%, is indicated for the treatment of acute keratoconjunctivitis and recurrent epithelial keratitis due to Herpes simplex virus types l and 2. The clinical diagnosis of keratitis caused by Herpes simplex virus is usually established by the presence of typical dendritic or geographic lesions on slit-lamp examination. It is also effective in superficial keratitis caused by Herpes simplex virus which has not responded to topical idoxuridine or when toxic or hypersensitivity reactions due to idoxuridine have occurred. The effectiveness of VIRA-A (vidarabine) Ophthalmic Ointment, 3%, against stromal keratitis and uveitis due to Herpes simplex virus has not been established.
DOSAGE AND ADMINISTRATION
Administer approximately one-half inch of VIRA-A (vidarabine) Ophthalmic Ointment, 3%, into the lower conjunctival sac five times daily at three-hour intervals.
If there are no signs of improvement after 7 days, or complete re-epithelialization has not occurred by 21 days, other forms of therapy should be considered. Some severe cases may require longer treatment.
Too frequent administration should be avoided.
After re-epithelialization has occurred, treatment for an additional 7 days at a reduced dosage (such as twice daily) is recommended in order to prevent recurrence.
The following topical antibiotics: gentamicin, erythromycin, chloramphenicol; or topical steroids: prednisolone or dexamethasone have been administered concurrently with VIRA-A (vidarabine) Ophthalmic Ointment, 3%.
VIRA-A (vidarabine) Ophthalmic Ointment, 3%, is supplied sterile in ophthalmic ointment tubes of 3.5 g. The base is a 60:40 mixture of solid and liquid petrolatum.
Store at room temperature 15°–30°C (59°F–86°F).
Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/8/2009
Additional Vira-A Information
Report Problems to the Food and Drug Administration
Find out what women really need.