Gatiflox ES0.5%

Gatiflox ES ophthalmic solution is a fluoroquinolone antibiotic eye drop used for the topical treatment of bacterial infections of the eye.

Established / FDA-Approved Use

• Treatment of bacterial conjunctivitis caused by susceptible strains of gram-positive organisms (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans group) and gram-negative organisms (e.g., Haemophilus influenzae, Pseudomonas aeruginosa).

Off-Label / Other Uses (physician discretion only)

• Peri-operative prophylaxis against ocular infection before or after eye surgery, used off-label by some ophthalmologists.
• Other external ocular infections (e.g., select cases of bacterial keratitis) under specialist supervision; not a first-line, formally approved indication.

Note: In Bangladesh, Gatiflox ES is marketed only as an ophthalmic (eye drop) preparation. Oral/systemic forms of Gatiflox ES are not available here and have been withdrawn or restricted in several countries due to safety concerns (see Precautions and Warnings).

Each mL of Gatifloxacin ophthalmic solution contains Gatifloxacin (as sesquihydrate) equivalent to 3 mg (0.3% w/v) or 5 mg (0.5% w/v) of Gatifloxacin, formulated as a sterile, buffered, isotonic solution for ophthalmic use, with benzalkonium chloride commonly used as a preservative.

Gatiflox ES is a fourth-generation, 8-methoxyfluoroquinolone antibacterial agent. In Bangladesh it is available exclusively as a sterile ophthalmic (eye drop) solution for topical use in the eye, in 0.3% and 0.5% strengths.

Systemic (oral/injectable) formulations of Gatiflox ES were previously marketed in some countries for respiratory and other infections, but were withdrawn or restricted after they were linked to a risk of significant blood glucose disturbances (dysglycemia). These systemic forms are not marketed in Bangladesh; only the topical ophthalmic form of Gatiflox ES is available and used here, which has a much more favorable local safety profile.

Ophthalmic anti-infective agent; Fluoroquinolone antibiotic for topical/ocular use.

Gatifloxacin is a broad-spectrum fluoroquinolone antibacterial that acts by inhibiting two bacterial topoisomerase enzymes, DNA gyrase (topoisomerase II) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. Inhibition of these enzymes is bactericidal.

When applied topically to the eye, systemic absorption of Gatifloxacin is minimal; plasma concentrations following ocular administration are typically very low or undetectable.

• Wash hands before use.
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed number of drops of Gatiflox ES into the affected eye(s).
• Avoid letting the dropper tip touch the eye, eyelid, fingers, or any other surface, to prevent contamination of the solution.
• Close the eye gently for 1–2 minutes after instillation.
• Do not wear contact lenses while signs or symptoms of bacterial conjunctivitis are present.
• If using more than one ophthalmic product, wait at least 5 minutes between different eye drops.

Because Gatiflox ES is applied topically to the eye with minimal systemic absorption, clinically significant drug-drug interactions are unlikely.

• Other topical ophthalmic products: if using more than one eye drop, separate administration by at least 5 minutes so that one product does not wash out another.
• No well-established, clinically significant systemic drug interactions have been documented for ophthalmic Gatiflox ES.

The most common side effects of Gatiflox ES eye drops are local and generally mild:

• Conjunctival irritation and increased lacrimation (most frequently reported)
• Eye pain or discomfort
• Blurred vision
• Dysgeusia (unpleasant/bitter taste after instillation)
• Papillary conjunctivitis
• Ocular pruritus (itching)
• Headache

Less commonly, keratitis, decreased visual acuity, or hypersensitivity reactions (eyelid swelling, redness) may occur. Seek medical attention if symptoms worsen, or if a rash, severe eye pain, or vision changes develop.

Gatiflox ES ophthalmic solution should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Although systemic absorption from eye drops is minimal, systemic fluoroquinolones have been associated with joint/cartilage effects in animal studies, so a physician should be consulted before use during pregnancy.

It is not established whether topically applied Gatiflox ES is excreted in human milk in clinically relevant amounts. Caution is advised, and a physician should be consulted before using Gatiflox ES while breastfeeding.

Gatiflox ES eye drops are for topical ophthalmic use only; they must not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

• Hypersensitivity reactions: discontinue at the first sign of a rash, allergic reaction, or other hypersensitivity symptoms (see Contraindications).
• Contact lenses: patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
• Prolonged use: may result in overgrowth of non-susceptible organisms, including fungi; if superinfection occurs, discontinue Gatiflox ES and start alternative therapy.
• Corneal healing: topical fluoroquinolones have rarely been associated with delayed corneal healing.
• Systemic fluoroquinolone-class risks (context): oral/systemic fluoroquinolones carry boxed warnings for tendinitis/tendon rupture, peripheral neuropathy (which can be irreversible), central nervous system effects, and exacerbation of myasthenia gravis, plus a risk of significant blood glucose disturbances (dysglycemia) that led to withdrawal of oral Gatiflox ES from several markets. Systemic absorption after ophthalmic use of Gatiflox ES is minimal, so these effects are not expected with the eye drop form, but patients with a history of these conditions should inform their physician before use.
• Antibiotic stewardship: take Gatiflox ES exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Topical overdose of Gatiflox ES eye drops is unlikely to cause systemic toxicity. Excess solution may be flushed from the eye with lukewarm water. If Gatiflox ES ophthalmic solution is accidentally swallowed, contact a physician, hospital emergency department, or poison control center immediately, or seek urgent medical attention. Do not attempt specific home treatment for a suspected significant overdose.

Store at room temperature (below 30°C), protected from light and moisture. Keep the bottle tightly closed and out of reach of children. Do not use Gatiflox ES after the printed expiry date, and discard any unused solution once the prescribed course is completed or as advised by your pharmacist.

Renal and Hepatic Impairment

No dose adjustment of ophthalmic Gatiflox ES is expected to be necessary in renal or hepatic impairment, since systemic absorption from topical ocular use is minimal.

Elderly

No specific dose adjustment of Gatiflox ES is required in elderly patients.

Pregnancy and Lactation

See the Pregnancy and Lactation section above.

Pediatric Use

See the Pediatric Uses section below.

The usual course of treatment with Gatiflox ES for bacterial conjunctivitis is 7 days. Even if eye symptoms improve earlier, the full prescribed course of Gatiflox ES should be completed to reduce the risk of recurrence and antibiotic resistance, unless a physician advises otherwise.

Fluoroquinolone antibiotic (8-methoxyfluoroquinolone); ophthalmic anti-infective agent.

Gatifloxacin kills susceptible bacteria by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA supercoiling, replication, and repair, resulting in bactericidal activity.

C

Gatiflox ES ophthalmic solution is approved for the treatment of bacterial conjunctivitis in children 1 year of age and older, using the same dosing regimen as adults.

The safety and efficacy of Gatiflox ES ophthalmic solution in infants younger than 1 year of age have not been established.