C Fenac Eye Drops

Diclofenac Sodium Eye prep
1 mg/ml
Chemist Laboratories Ltd.
Pack size 5 ml drop
Dispensing mode
Source
Agent
Retail Price 65 AED

Indications

C Fenac 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

C Fenac 1 mg/ml Eye Drops manufactured by Chemist Laboratories Ltd.. Its generic name is Diclofenac Sodium Eye prep. C Fenac is availble in Bangladesh. Farmaco BD drug index information on C Fenac Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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