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Diclogenta Eye Drop

Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Email: altinezvisions@gmail.com
Tel: 01-7418609, 08296588658, 0708900917

Brand Name

Diclogenta Eye Drop

Manufacturer

Centaur Pharmaceuticals Pvt. Ltd. Plant-1, Plot No. 3, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403526, India.

Therapeutic Class

Anti-infective/Non-steroidal anti-inflammatory drug combinations, Eye

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Eye drops (A4-4187): Diclofenac sodium 1 mg, Gentamicin sulphate equivalent to Gentamicin 3 mg, Benzalkonium chloride solution 0.01% (w/v).

Pack size: Plastic dropper bottle of 5 mL

Diclogenta

Pharmacology

Diclogenta Eye drops contain diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) with demonstrated anti-inflammatory and analgesic properties. It acts by inhibiting the enzyme cyclooxygenase, which is responsible for the biosynthesis of prostaglandins. Prostaglandins are the mediators of intra-ocular inflammation.

They have been shown to cause disruption of the blood-aqueous humor barrier, cause vasodilatation, increase vascular permeability, leukocytosis and increase intra-ocular pressure. Being a NSAID, diclofenac is devoid of the side effects of steroids such as reduced immune response, raised intra-ocular pressure and cataract formation. Clinical studies demonstrate it to be equipotent to steroids in treating ocular conditions.

Gentamicin, in Diclogenta Eye drops, is an aminoglycoside antibiotic active against common ocular pathogens including coagulase-positive and coagulase-negative Staphylococci, Group A betahemolytic and non-hemolytic Streptococci and Streptococcus pneumoniae, P. aeruginosa, indole-positive and lndole-negative Proteus, E. coli, Citrobacter, Moraxella, Providencia and Neisseria.

Indications

Diclogenta Eye drops is indicated for the postoperative management of patients undergoing extracapsular cataract surgery and lens implantation.

Diclogenta Eye drops can also be used for the treatment of superficial bacterial infections, for prevention of ocular infection if injury makes the eye or adjacent area vulnerable and after removal of foreign bodies.

Contra-indications

Hypersensitivity to any ingredient of the formulation. As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft contact lenses during treatment with this drug.

Precautions/Warnings

Patients who are allergic to aspirin or other NSAIDs should be prescribed this drug with caution. Use of topical antibiotics occasionally allows overgrowth of non-susceptible microorganisms such as fungi.

If this occurs or if irritation or sensitation to any of the components of this preparation develops, treatment should be discontinued. This formulation is not to be used as an one preparation.

PREGNANCY & LACTATION:

The safe use of this preparation during pregnancy has not been established. At the same time, it is not known whether its components are secreted in human milk. Therefore, caution should be exercised when prescribed to a pregnant or a nursing woman.

Interactions

There are no major drug-drug interactions with the use of Diclogenta Eye Drops.

It may be concurrently used with cycloplegics, mydriatics, beta-blockers, antibacterials and carbonic anhydrase inhibitors.

This preparation should be used with caution along with oral anticoagulants.

Adverse Effects

The most frequently reported adverse reactions with Diclogenta Eye Drops include burning sensation, irritation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctiva/ hyperemia.

PATIENT INFORMATION:

To prevent contaminating the dropper tip and solution, advise patients to take care not to touch any surface, the eye lids, or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. This product is sterile when packaged.

The preservative benzalkonium chloride may be absorbed by son contact lenses. Instruct patients who wear soft contact lenses to wait at least 10 minutes after instilling before they insert their contact lenses.

Dosage & Administration

The usual recommended dose of Diclogenta Eye Drops for control of post surgery inflammation is 1-drop to the affected eye 4-times daily beginning 24 - hours after surgery and continuing throughout the first 2- weeks of the postoperative period.

Storage/Handling Recommendations

Store at temperature between 15 - 30°C in a dark place.

Do not freeze.

Keep medicines out of the reach of children.

Review Date

2016-05-10 12:16:37