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DUCRESSA is a brand name for Levofloxacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Summary of the safety profile In clinical studies, 438 patients have been treated with Ducressa. No serious adverse reactions occurred. The most commonly reported non-serious adverse reactions are eye irritation, ocular hypertension and headache.
Tabulated list of adverse reactions The following adverse reactions have been reported with Ducressa during clinical trials that enrolled patients after cataract surgery (within each frequency grouping, adverse reactions are presented in order of decreasing frequency).
The frequency of possible adverse reactions listed below is defined using the following convention: very common ≥ 1/10 common ≥ 1/100 to <1/10 uncommon ≥1/1,000 to <1/100 rare ≥1/10,000 to <1/1,000 very rare ≤1/10,000 not known Frequency cannot be estimated from the available data Ducressa (levofloxacin/dexamethasone combination) System Organ Class Frequency Adverse reactions Nervous system disorders Uncommon Headache, dysgeusia.
Eye disorders Uncommon Eye irritation, abnormal sensation in eye, ocular hypertension. Skin and subcutaneous tissue disorders Uncommon Pruritus. Investigations Uncommon Intraocular pressure increased (*). (*) > 6 mmHg that means significant intraocular pressure increase Adverse reactions that have been seen with either of the ophthalmic active substances (levofloxacin or dexamethasone), and may potentially occur also with Ducressa are listed below: Levofloxacin System Organ Class Frequency Adverse reactions Immune system disorders Rare Extra-ocular allergic reactions, including skin rash.
Very rare Anaphylaxis. Nervous system disorders Uncommon Headache. Common Ocular burning, decreased vision and mucous strand. Eye disorders Uncommon Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival hyperaemia, conjunctival follicles, ocular dryness, lid erythema, and photophobia.
Ocular effects Ducressa is for ocular use only. Ducressa must not be injected sub- conjunctively. The solution should not be introduced directly into the anterior chamber of the eye. Prolonged use may induce antibiotic resistance with result of overgrowth of non-susceptible organisms, including fungi.
If infection develops, the treatment should be discontinued and alternative therapy used. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension/glaucoma but this is unlikely when Ducressa is used for the recommended treatment period (7 days). In any case, it is advisable that the intraocular pressure be checked frequently.
g. diabetes). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may be related to complications to cataract surgery, development of glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical ocular NSAIDs are also known to slow or delay healing. Concomitant use of topical ocular NSAIDs and steroids may increase the potential for healing problems. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
Deleted: , Systemic effects Fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids.
1; • 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Respiratory, thoracic and mediastinal disorders Very rare Laryngeal oedema. * Eye disorders Very rare Conjunctivitis, mydriasis, ptosis, corticosteroid-induced uveitis, corneal calcifications, crystalline keratopathy, changes in corneal thickness*, corneal oedema, corneal ulceration and corneal perforation.
Skin and subcutaneous tissue disorders Very rare Face oedema. Endocrine disorders Not known Cushing’s syndrome, adrenal suppression. * see section Description of selected adverse reactions Description of selected adverse reactions Increase of intraocular pressure Increase of the intra-ocular pressure (IOP) and glaucoma may occur.
Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous high IOP induced by steroids or with pre-existing high IOP or glaucoma). 4). Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration.
g. corneal oedema, eye irritation, abnormal sensation in the eye, lacrimation increased, asthenopia, corneal disorder, dry eye, eye pain, ocular discomfort, uveitis, blurred vision, visual brightness, conjunctivitis) and nausea have been reported during clinical trials.
These reactions are usually mild and transient and are assessed to be related to the cataract surgery itself. 4). Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Additional adverse reactions that have been observed with prolonged use of the active substance levofloxacin and may potentially occur also with Ducressa Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
8). Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat).
In these cases, treatment should be progressively discontinued. Effects on Immune System Prolonged use (generally observed within 2 weeks of treatment) may also result in secondary ocular infections (bacterial, viral, or fungal) due to suppression of host response or to the delay of their healing.
In addition, topical ocular corticosteroids may promote, aggravate or mask signs and symptoms of eye infections caused by opportunistic microorganisms. Occurrence of these conditions is limited in case of short term corticosteroid treatment such as the one suggested for Ducressa.
Excipients Benzalkonium chloride Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use. After cataract surgery patients should not wear contact lenses for the whole duration of therapy with Ducressa.