Ducressa

Ducressa

Manufacturer:

Tubilux Pharma

Distributor:

Santen
Concise Prescribing Info
Contents
Per mL Levofloxacin hemihydrate 5 mg, dexamethasone Na phosphate 1 mg
Indications/Uses
Prevention & treatment of inflammation; prevention of infection associated w/ cataract surgery in adults.
Dosage/Direction for Use
Instill 1 drop into the conjunctival sac after surgery every 6 hr for 7 days. Instillation should be spaced out by 15 min in case of concomitant treatment w/ other eye drops soln.
Contraindications
Hypersensitivity to levofloxacin, other quinolones, dexamethasone or other steroids. Herpes simplex keratitis, varicella & other viral disease of the cornea & conjunctiva. Mycobacterial infections of the eye caused by but not limited to acid-fast bacilli eg, Mycobacterium tuberculosis, Mycobacterium leprae or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye.
Special Precautions
Discontinue use if infection develops; if allergic reaction occurs; at 1st sign of tendon inflammation; in cases of Cushing's syndrome &/or adrenal suppression. Do not prematurely discontinue use. Not to be inj sub-conjunctively. Not to be introduced directly into the anterior chamber of the eye. Do not wear contact lenses after surgery for whole duration of therapy. Dry eye patients & patients whose cornea may be compromised. Prolonged use may induce antibiotic resistance w/ result of overgrowth of nonsusceptible organisms including fungi. Prolonged use (w/in 2 wk of treatment) may result in secondary ocular infections (bacterial, viral, or fungal). Examine patient w/ aid of magnification (eg, slit-lamp biomicroscopy) & fluorescein staining. Monitor patients during prolonged use. Systemic absorption may be reduced w/ nasolacrimal occlusion by compression of lacrimal ducts. Contains benzalkonium Cl. Temporarily blurred vision or other visual disturbances may affect ability to drive or use machines. Renal/hepatic impairment. Not recommended during pregnancy & especially during 1st 3 mth. No data are available to whether relevant amounts of dexamethasone are transferred into human milk. Not recommended in childn & adolescents <18 yr. Dexamethasone: Increased risk of corticosteroid-induced IOP in predisposed patients eg, diabetes. May slow corneal wound healing. Perforations in diseases causing thinning of the cornea or sclera. May promote, aggravate or mask signs & symptoms of eye infections caused by opportunistic microorganisms. Frequently check IOP. Consider referral to an ophthalmologist if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Concomitant use w/ topical ocular NSAIDs may increase potential for healing problems.
Adverse Reactions
Headache, dysgeusia, eye irritation, abnormal sensation in eye, ocular HTN, pruritus & increase IOP.
Drug Interactions
May increase potential for corneal healing problems w/ topical NSAIDs. Clearance may be decreased w/ CYP3A4 inhibitors (including ritonavir & cobicistat).
MIMS Class
Eye Antiseptics with Corticosteroids
ATC Classification
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Form
Ducressa ophth soln
Packing/Price
5 mL x 1's
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