Dexaflox Drops 5 ml
Jamjoom Pharmaceuticals
Jamjoom Pharmaceuticals
Composition
Active Ingredients: Each ml contains
Ofloxacin – 3.0 mg
Dexamethasone – 1.0 mgFor a complete list of excipients, see section 6.1.
Description
Dexaflox Eye Drops is a combined ophthalmic suspension containing Ofloxacin (3.0 mg) and Dexamethasone (1.0 mg). It is used for the treatment of bacterial eye infections, inflammatory conditions of the eye, and post-surgical recovery. Ofloxacin is a fluoroquinolone antibiotic that helps eliminate bacterial infections, while Dexamethasone is a corticosteroid that reduces inflammation and swelling. Dexaflox is prescribed for conjunctivitis, keratitis, uveitis, corneal injuries, and post-operative care. It helps relieve eye discomfort, redness, and irritation while preventing bacterial infections.
Indications
Dexaflox Eye Drops are indicated for the treatment of corticosteroid-responsive inflammatory conditions affecting the conjunctiva, cornea, and anterior segment of the eye where bacterial infections or the risk of bacterial infection exists.
-Chronic anterior uveitis
-Corneal injuries due to chemical, radiation, or thermal burns
-Penetration of foreign bodies
-Post-operative management of cataract, trabeculectomy, and refractive surgeries
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children Over 2 Years
Instill 1–2 drops into the affected eye(s) every 4 to 6 hours for the first 48 hours.
After infection and inflammation are controlled, gradually reduce frequency while continuing treatment for 48 hours after healing.
Method of Administration
For ophthalmic use only.
Shake well before use.
Avoid touching the dropper tip to any surface to prevent contamination.
CONTRAINDICATIONS
Dexaflox is contraindicated in individuals with
-Hypersensitivity to ofloxacin, dexamethasone, quinolones, or any excipient.
-Viral infections of the cornea and conjunctiva, such as varicella or vaccinia (except herpes zoster keratitis)
-Herpes simplex keratitis
-Fungal infections of ocular structures
PRECAUTIONS
-Prolonged use of corticosteroids may lead to increased intraocular pressure (IOP), glaucoma, and optic nerve damage.
-Use in patients with glaucoma requires close monitoring.
-Corticosteroids may mask infections and reduce resistance to bacterial, viral, and fungal infections.
-Topical corticosteroids should not be used for more than one week without ophthalmic supervision.
-Patients should avoid wearing contact lenses during treatment.
-Contains benzalkonium chloride, which may cause eye irritation and discolor soft contact lenses. Contact lenses should be removed before application and reinserted after 15 minutes.
-Hypersensitivity reactions (including anaphylaxis) have been reported. Discontinue use if an allergic reaction occurs.
-Use with caution in patients with QT prolongation risks, including congenital long QT syndrome, electrolyte imbalance, or concurrent use of QT-prolonging drugs.
-Prolonged use may result in bacterial resistance and superinfection.
PREGNANCY AND LACTATION
Pregnancy
There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk.
Lactation
Since ofloxacin and dexamethasone are excreted in breast milk, a decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of treatment for the mother.
SIDE EFFECTS
-Common (≥1/100 to <1/10)
Eye discomfort, Eye irritation
-Uncommon (≥1/1,000 to <1/100)
Conjunctivitis, Keratitis, Blurred vision, Dry eye, Photophobia, Eyelid edema
-Not Known (frequency cannot be estimated from available data):
Endocrine disorders: Cushing's syndrome, adrenal suppression
Nervous system disorders: Dizziness, headache
Eye disorders: Increased intraocular pressure, corneal erosion, mydriasis, visual acuity reduction, ptosis
Cardiac disorders: Ventricular arrhythmia, QT prolongation, torsades de pointes (in predisposed patients)
Gastrointestinal disorders: Nausea
Skin disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
-Prolonged corticosteroid use may lead to optic nerve damage, posterior subcapsular cataract formation, and increased intraocular pressure.
-Patients with thin corneas or sclera are at higher risk of perforation.
-Corticosteroids may slow wound healing and reduce immune resistance, potentially worsening infections.
-Visual disturbances, including central serous chorioretinopathy (CSCR), have been reported. Patients with blurred vision should seek ophthalmologic evaluation.
STORAGE
Store at a temperature not exceeding 25°C.
Keep out of reach of children.
PACKAGE
A carton box containing a plastic dropper bottle 5 ml.