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HSA Approval

DUCRESSA EYE DROPS SOLUTION 1MG/ML + 5MG/ML

SIN16596P

DUCRESSA EYE DROPS SOLUTION 1MG/ML + 5MG/ML

DUCRESSA EYE DROPS SOLUTION 1MG/ML + 5MG/ML

September 7, 2022

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**4.2 Posology and method of administration** Posology One drop instilled into the conjunctival sac after surgery every 6 hours. Duration of treatment is 7 days. Care should be taken not to discontinue therapy prematurely. If one dose is missed, treatment should continue with the next dose as planned. Re-evaluation of the patient to assess the need to continue the administration of corticosteroid eye drops as monotherapy is recommended after the completion of one week of therapy with Ducressa eye drops. The length of this treatment can depend on the patient’s risk factors and outcome of surgery and must be determined by the doctor according to slit-lamp microscopic findings and depending on the severity of the clinical picture. A follow-up treatment with steroid eye drops should not normally exceed 2 weeks. However, care should be taken not to discontinue therapy prematurely. _Paediatric population:_ The safety and efficacy of Ducressa in children and adolescents below the age of 18 years have not been established. No data are available. Ducressa is not recommended for use in children and adolescents below the age of 18 years. _Elderly patients:_ No dosage adjustment in elderly patients is necessary. _Use in renal/hepatic impairment_ Ducressa has not been studied in patients with renal/hepatic impairment and Ducressa should therefore be used with caution in such patients. Method of administration Ocular use. One drop should be administered in the lateral canthus while applying pressure at the medial canthus to prevent drainage of the drops. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Nasolacrimal occlusion by compression of lacrimal ducts may reduce systemic absorption. In case of concomitant treatment with other eye drops solutions, instillations should be spaced out by 15 minutes.

OPHTHALMIC

Medical Information

**4.1 Therapeutic indications** Ducressa eye drops solution is indicated for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

**4.3 Contraindications** - Hypersensitivity to active substance levofloxacin or to other quinolones, to dexamethasone, or to other steroids, or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_; - Herpes simplex keratitis, varicella and other viral disease of the cornea and conjunctiva; - Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium; - Fungal diseases of ocular structures; - Untreated purulent infection of the eye.

S01CA01

dexamethasone and antiinfectives

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

TUBILUX PHARMA S.p.A.

Active Ingredients

Dexamethasone sodium phosphate 1.32mg/mL (eqv to Dexamethasone)

1.00mg/mL

Dexamethasone

Levofloxacin hemihydrate 5.12mg/mL (eqv to Levofloxacin)

5.00mg/mL

Levofloxacin

Documents

Package Inserts

Ducressa PI.pdf

Approved: September 7, 2022

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