Floxalone-DX
Generic Name
Gatifloxacin 0.5% + Dexamethasone 0.1% Eye Drop
Manufacturer
Generic Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| floxalone dx 05 01 eye drop | ৳ 230.00 | N/A |
Description
Overview of the medicine
Floxalone-DX 0.5/0.1 eye drop is a combination medication containing an antibiotic (gatifloxacin) and a corticosteroid (dexamethasone) used to treat bacterial eye infections where inflammation is also present or anticipated.
Uses & Indications
Dosage
Adults
Instill one drop into the affected eye(s) 3-4 times daily for up to 7 days, or as directed by a physician. In severe cases, dosage may be increased initially.
Elderly
No specific dosage adjustment required for elderly patients.
Renal_impairment
No specific dosage adjustment required for patients with renal impairment with topical ophthalmic use.
How to Take
For ophthalmic use only. Wash hands before use. Tilt head back, pull down lower eyelid to form a pouch. Instill one drop, then close eye gently. Do not touch the dropper tip to any surface. If using other eye drops, wait at least 5 minutes between applications.
Mechanism of Action
Gatifloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication, transcription, repair, and recombination, leading to bacterial cell death. Dexamethasone is a potent corticosteroid that suppresses inflammation by inhibiting phospholipase A2 and reducing the release of inflammatory mediators.
Pharmacokinetics
Onset
Antibacterial effect within hours; anti-inflammatory effect within hours to days.
Excretion
Gatifloxacin is primarily excreted unchanged in urine. Dexamethasone metabolites are excreted in urine.
Half life
Systemic half-life of gatifloxacin is approximately 5-8 hours. Ocular half-life is shorter due to tear turnover. Dexamethasone systemic half-life 3-4.5 hours.
Absorption
Systemic absorption is minimal following ophthalmic administration. Gatifloxacin and Dexamethasone achieve therapeutic concentrations in ocular tissues.
Metabolism
Gatifloxacin is minimally metabolized. Dexamethasone is metabolized primarily in the liver.
Side Effects
Contraindications
- Hypersensitivity to gatifloxacin, dexamethasone, or any component of the formulation
- Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis, vaccinia, varicella)
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
Drug Interactions
Systemic corticosteroids
Concomitant use of systemic corticosteroids may increase the risk of systemic side effects, although minimal with ophthalmic use.
Other topical ophthalmic medications
If more than one topical ophthalmic medication is being used, they should be administered at least 5 minutes apart.
Storage
Store at room temperature (below 30°C). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
An acute overdose is unlikely to cause systemic toxicity due to limited systemic absorption. If accidentally ingested, drink fluids to dilute. Ocular overdose can be flushed with warm tap water.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone is excreted in human milk; caution should be exercised when administered to a nursing mother. Consult a physician.
Side Effects
Contraindications
- Hypersensitivity to gatifloxacin, dexamethasone, or any component of the formulation
- Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis, vaccinia, varicella)
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
Drug Interactions
Systemic corticosteroids
Concomitant use of systemic corticosteroids may increase the risk of systemic side effects, although minimal with ophthalmic use.
Other topical ophthalmic medications
If more than one topical ophthalmic medication is being used, they should be administered at least 5 minutes apart.
Storage
Store at room temperature (below 30°C). Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
An acute overdose is unlikely to cause systemic toxicity due to limited systemic absorption. If accidentally ingested, drink fluids to dilute. Ocular overdose can be flushed with warm tap water.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone is excreted in human milk; caution should be exercised when administered to a nursing mother. Consult a physician.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months (unopened). Discard 28 days after opening.
Availability
Pharmacies, Hospitals
Approval Status
Approved by health authorities in various countries
Patent Status
Patent expired for generic components
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of gatifloxacin and dexamethasone in treating bacterial conjunctivitis and ocular inflammation. Specific trials for this combination confirm superior outcomes compared to monotherapy for certain conditions.
Lab Monitoring
- Intraocular pressure (IOP) monitoring with prolonged corticosteroid use (more than 10 days).
Doctor Notes
- Emphasize the importance of completing the full course of antibiotic therapy even if symptoms improve.
- Advise patients about potential for elevated IOP with prolonged use and the need for regular monitoring.
- Educate on the potential for secondary infections, especially fungal, with corticosteroid use.
- Contraindicated in suspected viral or fungal infections.
Patient Guidelines
- Use exactly as prescribed by your doctor.
- Do not wear contact lenses during treatment of eye infection.
- Avoid touching the dropper tip to prevent contamination.
- Do not share your eye drops with others.
Missed Dose Advice
If a dose is missed, apply it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose.
Driving Precautions
May cause temporary blurred vision. Avoid driving or operating machinery until vision is clear.
Lifestyle Advice
- Maintain good hand hygiene.
- Avoid rubbing eyes excessively.
- Protect eyes from dust and irritants.
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Global Brand Names
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