Anfenac Eye Drops
Diclofenac Sodium Eye prep
1 mg/ml
Nipa Pharmaceuticals Ltd.
| Pack size | 5 ml drop |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 80.00 AED |
Indications
Anfenac Eye Drops is used for:
Allergic conjunctivitis, Ocular inflammation, Miosis
Adult Dose
Ophthalmic
Diclofenac Sodium 0.1% Eye Prep
Cataract Surgery
1 drop in affected eye(s) four times daily for 2 weeks, beginning 24 hours post-surgery
Corneal Refractive Surgery
1-2 drops in affected eye(s) within 1 hour pre-op & 15 minutes post-op; continue 1-2 drops four times daily for 3 days
Inflammatory conditions
Instill 1 drop in the conjunctival sac 4-5 times daily depending upon the severity of the diseases.
Child Dose
Safety & efficacy not established
Renal Dose
Administration
Contra Indications
Contraindicated to patients hypersensitive to Diclofenac Sodium or any other of its ingredients.
Diclofenac sodium is also contraindicated in patients who may have NSAID induced asthma, urticaria, or acute rhinitis.
Precautions
Contains sodium sulfite which may cause allergic reactions in susceptible individuals NSAIDs
Concomitant use of topical NSAIDs and topical steroids may increase potential for healing problems
There is potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents; use caution should when treating individuals who have previously exhibited sensitivities to these drugs
Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time; use of same bottle for both eyes is not recommended with topical eye drops used in association with surgery
There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery
Use of topical NSAIDs may result in keratitis; in some susceptible patients continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation; these events may be sight-threatening
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health
Remove contact lenses before application, may reinsert 10 minutes after instilling drops
Corneal adverse reactions may occur in patients with keratitis after continued use that may result in loss of vision; discontinue use in patients with evidence of corneal epithelial damage
Use caution in patients with diabetes (may be at risk of corneal adverse effects that may result in loss of vision)
Postmarketing experience with topical NSAIDs suggests that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (eg, dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within short period-of time may be at increased risk for corneal adverse events, which may become sight-threatening; topical NSAIDs should be used with caution in these patients
Postmarketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for occurrence and severity of corneal adverse events
Results from clinical studies indicate that this drug has no significant effect upon ocular pressure; however, elevations in intraocular pressure may occur following cataract surgery
Use caution in patients with rheumatoid arthritis
Pregnancy-Lactation
Pregnancy
Reproduction studies performed in mice at oral doses up to 5,000 times (20 mg/kg/day) and in rats and rabbits at oral doses up to 2,500 times (10 mg/kg/day) human topical dose have revealed no evidence of teratogenicity due to this drug despite induction of maternal toxicity and fetal toxicity
In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival; this drug has been shown to cross the placental barrier in mice and rats
There are, however, no adequate and well-controlled studies in pregnant women; because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed
Because of known effects of prostaglandin biosynthesis inhibiting drugs on fetal cardiovascular system (closure of ductus arteriosus), the use of this drug during late pregnancy should be avoided
Lactation
Not known whether topical ophthalmic administration of this drug could result in sufficient systemic absorption to produce detectable quantities in breast milk
Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account importance of the drug to mother
Interactions
May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids.
Ophthalmic application of diclofenac may reduce the efficacy of ophthalmic acetylcholine and carbachol.
Adverse Effects
Side effects of Diclofenac Sodium Eye prep :
Frequency Not Defined
Mild ocular stinging, irritation
May slow corneal wound healing
Lacrimation
Increased IOP
Keratitis
Dizziness
Insomnia
Pain
Fever
Chills
Nausea/vomiting
Abdominal pain
Corneal deposits
Corneal edema
Conjunctivitis
Irritation
Eyelid swelling
Corneal perforation
Corneal thinning
Mechanism of Action
Inhibits cyclooxygenase (COX)-1 and COX-2, thereby inhibiting prostaglandin synthesis.May also inhibit neutrophil aggregation/activation, inhibit chemotaxis, decrease proinflammatory cytokine level, and alter lymphocyte activity.
Note
Anfenac 1 mg/ml Eye Drops manufactured by Nipa Pharmaceuticals Ltd.. Its generic name is Diclofenac Sodium Eye prep. Anfenac is availble in Bangladesh.
Farmaco BD drug index information on Anfenac Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.