A change to make a difference


GATIDEX
Eye Drops


Gatifloxacin is a broad-spectrum 8- methoxy fluoroquinolone effective against a wide range of bacterial pathogens and has an increased potency against gram-positive and gram-negative bacteria. Dexamethasone is a long acting synthetic powerful steroid. It has the most potent anti-inflammatory and the most potent anti-allergic action. Thus, the combination will effectively resolve infection and associated inflammation in severe eye conditions.

Gatifloxacin inhibit bacterial DNA gyrase, the enzyme responsible for replication, transcription and repair of bacterial DNA and Topoisomerase IV responsible for partitioning of the chromosomal DNA during bacterial cell division, thus cause death of bacteria. Dexamethasone suppresses the inflammation by decreasing the production of inflammatory mediators through the inhibition of the enzyme Phospholipase A2.


Feature:
Gatidex Eye Drops – there are Benzalkonium Chloride (BAK) as Preservative

Advantage:
* Prevent contamination of solution in the Bottle & Keep the drug stable
* Help to augment antimicrobial activity of Gatifloxacin
* Help penetration of drugs in to the Target Organisms

Benefit:
Increase the speed of killing of Susceptible Pathogens


Feature:
Gatidex Eye Drops – there are Dexamethasone as Active Ingredient

Advantage:
Dexamethasoneis a Powerful steroid, reduces the irritation, redness, burning and swelling caused by chemicals, heat, radiation, infection, allergy or foreign bodies.

Benefit:
Promptly reduces ocular Inflammation


Feature:
There are Gatifloxacin, A new 4th generation Fluoroquinolone

Advantage:
# 8-methoxy group expands the spectrum of activity of the agents to include gram-positive pathogens and
even anaerobes
# Cyclopropyl group maintain gram-negative Activity
# Bactericidal Mechanism of Action, Biocompatibiliy & Bioavailibility with favourable pharmacodynamics
#Start action within 15 minutes of exposure

Benefit:
Cures a wide range of Infections & Ensures patients’ compliance


Composition : Each ml solution contains Gatifloxacin 3 mg as Gatifloxacin Sesquihydrate INN & Dexamethasone Phosphate 1 mg as Dexamethasone Sodium Phosphate BP. Preservative: Benzalkonium Chloride 0.01%

Indications : Steroid responsive inflammatory conditions with involvement of bacteria;
Such as-
¨ Blepharitis, Scleritis, Episcleritis, Iritis, Cyclitis, Iridocyclitis, Choroiditis, Optic neuritis and chronic anterior uveitis.
¨ Disciform and interstitial keratitis
¨ Allergic corneal marginal ulcers
¨ Corneal injury from chemical radiation or thermal burns

Dosage & administration : Instill 1-2 drops into the conjunctival sac 3 to 4 times a day.

Contraindications : Gatidex Eye Drops are contraindicated in fungal disease of ocular structures, viral conjunctivitis and Hypersensitivity to any of the components of the formulation.

Pediatric Use : The safety in Paediatric patients has not been established.

Pregnancy : Gatidex eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactation : Gatifloxacin or Dexamethasone has not been measured in human milk, although it can be presumed to be excreted in human milk following topical administration. Caution should be exercised when the combination is administered to a nursing woman.

Side Effects : Frequently reported reactions related to Gatifloxacin are transient ocular burning or discomfort. Other reported reactions include chemosis, redness, dry eye, pain, itching, swelling of the eyelid & reduced visual acuity. The reactions due to steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent Optic nerve damage, delayed wound healing and posterior subcapsular cataract formation. Secondary infection may develop after use of combination containing steroid & antibacterial. Fungal or viral infections of the cornea are particularly prone to develop coincidently with long-term use of steroids.

Warning & Precaution : If the product is used for 10 days or more, intra ocular pressure should be monitored routinely. Prolonged use of steroid may result in glaucoma, elevated intraocular pressure or other ocular damage. It may exacerbate severity of viral infections. Use cautiously in patients with history of herpes simplex.

Package quantities : Gatidex Eye Drops are supplied in 5 ml Polyethylene bottle

Storage : Keep in a dry & cool place, Protect from light. Keep out of the reach of children.



Ref: Product Management Department, Opso Saline Ltd., Bangladesh