Ducressa

Ducressa

Manufacturer:

Tubilux Pharma

Distributor:

Zuellig Pharma

Marketer:

Santen
Concise Prescribing Info
Contents
Per 1 mL Dexamethasone 1 mg, levofloxacin 5 mg
Indications/Uses
Prevention & treatment of inflammation & prevention of infection associated w/ cataract surgery in adults.
Dosage/Direction for Use
1 drop instilled into the conjunctival sac after surgery every 6 hr for 7 days.
Contraindications
Hypersensitivity to levofloxacin or to other quinolones, dexamethasone or other steroids. Herpes simplex keratitis, varicella & other corneal & conjunctival viral disease. Mycobacterial eye infections caused by, but not limited to, acid-fast bacilli (eg, Mycobacterium tuberculosis, Mycobacterium leprae or Mycobacterium avium). Fungal diseases of ocular structures. Untreated purulent eye infection.
Special Precautions
Discontinue use if allergic reaction occurs. For ocular use only. Not to be inj sub-conjunctively; not to be introduced directly into anterior chamber of the eye. Prolonged use may induce antibiotic resistance w/ result of non-susceptible organism overgrowth including fungi. Discontinue if infection develops & use alternative therapy. Prolonged use may result in ocular HTN/glaucoma; frequently check IOP; risk of corticosteroid-induced increased IOP in predisposed patients (eg, diabetes). Consider referral to ophthalmologist if patient presents w/ symptoms eg, blurred vision or other visual disturbances for evaluation of possible causes which may be related to complications to cataract surgery, development of glaucoma or rare diseases eg, central serous chorioretinopathy. May increase potential for healing problems w/ concomitant use of topical ocular NSAIDs & steroids. Possible perforations in diseases causing corneal or scleral thinning. Tendon inflammation & rupture may occur particularly in elderly & those treated concurrently w/ corticosteroids; discontinue at the 1st sign of tendon inflammation. Cushing's syndrome &/or adrenal suppression may occur; progressively discontinue treatment in predisposed patients including childn & those treated w/ CYP3A4 inhibitors (including ritonavir & cobicistat). Prolonged use (w/in 2 wk of treatment) may result in secondary ocular infections (bacterial, viral or fungal). May promote, aggravate or mask signs & symptoms of eye infections caused by opportunistic microorganisms. Dry eye patients & those where the cornea may be compromised; monitor in case of prolonged use. Cataract surgery patients should not wear contact lenses for the whole duration of therapy. Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. Renal & hepatic impairment. Not recommended during pregnancy especially during the 1st 3 mth. Lactation. Not recommended for use in childn & adolescents <18 yr.
Adverse Reactions
Levofloxacin: Ocular burning, decreased vision & mucous strand. Dexamethasone: Increased IOP. Discomfort, irritation, burning, stinging, itching & blurred vision.
Drug Interactions
May increase potential for corneal healing problems w/ topical steroids & NSAIDs. May decrease dexamethasone clearance resulting in increased effects w/ CYP3A4 inhibitors (including ritonavir & cobicistat).
MIMS Class
Eye Anti-Infectives & Antiseptics
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 eye drops
Packing/Price
5 mL x 1's
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