Clinical Pharmacology :

 

PHARMACODYNAMICS

Nepasite suspension contains nepafenac,a nonsteroid anti-inflammatory and analgesic penetrates the cornea and its converted by ocular issue hydro lases to fennac a nonsteroidal anti-inflammatory and analgestic prodrug.After topical ocular dosing,nepatenac penetrates the comea and is converted by ocular issue hydro lases to amfenac,a nonsteroid H synthase (cydooxygenase)an enzyme required for prostaglandin production.

PHARMACOKINETICS

Drug-Drug interaction:Nepafenac at concentrations up to 300ng/ml did not inhibit the in vitro metabolism of 6 specific marker subtrates of cytochrome P450 isozyme (CYP1A2,CYP2C9,CYP206,CYP2E1 and CYP3A4)Therefore,drug-drug interactions involving CYP-mediated metabolism of concomitanty administered drugs are ulikely.Drug-drug interactions mediated by protein binding are also unlikely.

INDICATIONS AND USAGE

Nepasite ophthalmic suspens on is indicated for the treatment of pain and inflammation associated with cataract surgery.

CONTRAINDICATIONS

Nepasite ophthalmic suspension is contraindicated in patients with previously demonstrated hypersensitivity to other NSAIS.

WARNING : FOR TOPICAL OPHTHALMIC USE ONLY NOT FOR INJECTION.

There is the potential for cross-senstivity to acetylsalicytic acid,phenylacetic acid derivatives and other nonstatoidal anti-inflammatory agents Therefore,caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.With some non-stereidal anti-inflammatory drugs including Nepasite ophthalmic suspension there exist the potential for increased bleeding time due to interference with thrombocyte aggregation.there have been reports that ocularly tissues(including hyphemas)in conjunction with ocular surgery.

PRECAUTIONS :

General : Topical non-steroidal anti-inflammatory drugs (NSAIDs) including Nepasite ophthalmic suspension,may slow or delay heating.Topical corticosteroids are also known to slow or delay heating.Concomitant use of topical NSAIDs may result in epithening breakdown should immediately discontinue use of topical NSAIDs including Nepasite opthaimic suspension and should be closely monitored for corneal health.

PEDIATRIC USE :

The safety and effectiveness of Nepasite ophthaimic suspension in paediatric patients below the age of 10 years have been established.

ADVERSE REACTION

In controlled clinical studies the most irequntly reported ocular adverse events following cataract surgery were capsular opacity decreased visual acuity.foreign body sensation,Increased intracullar.

DOSAGE AND ADMINISTRATION

One drop of nepasite ophthaimic suspension 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 postoperative period or as directed by the physian.

Storage : Store at 2- 26C

SHAKE WELL BEFORE USE.