Description
NEFEN nepafenac ophthalmic suspension 0.1% is a sterile, topical, nonsteroidal
anti inflammatory (NSAID). After topical ocular dosing, nepafenac penetrates
the cornea and is converted by ocular tissue hydrolases to amfenac, a
nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action
of prostaglandin H synthase (cyclo oxygenase), an enzyme required for
prostaglandin production.
Indications
NEFEN nepafenac ophthalmic suspension is indicated for the treatment of pain
and inflammation associated with cataract surgery.
Dosage
and administration
One drop of Nefen should be applied to
the affected eye(s) three-times-daily beginning 1 day prior to cataract
surgery, continued on the day of surgery and through the first 2 weeks of the
post operative period.
Contraindications
NEFEN is contraindicated in patients with previously demonstrated
hypersensitivity to any of the ingredients in the formula or to other NSAIDs.
Warnings
There is the potential for cross-sensitivity to acetylsalicylic acid,
phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents.
Therefore, caution should be used when treating individuals who have previously
exhibited sensitivities to these drugs
Precautions
Topical
Nonsteroidal anti-inflammatory drugs (NSAIDs) including Nefen , may slow
or delay healing. Topical corticosteroids are also known to slow or delay
healing. Concomitant use of topical NSAIDs and topical steroids may increase
the potential for healing problems.
Pregnancy
Category C
NEFEN should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing
Mothers
NEFEN ophthalmic suspension is excreted in the milk of pregnant rats. It is not
known whether this drug is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when Nefen ophthalmic suspension is administered to a
nursing woman.
Pediatric
Use
The safety and effectiveness of Nefen
in pediatric patients below the age of 10 years have not been
established.
Storage
Store in a cool & dark place
Presentation
NEFEN is available in plastic bottle of 5 ml