Dexamethasone and levofloxacin ocular
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Eye drops containing dexamethasone and levofloxacin.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of infection following cataract surgery
Topical prophylaxis and treatment of inflammation after cataract surgery
Dosage
Adults
Instil 1 drop into the conjunctival sac (lateral canthus) after surgery every 6 hours.
Treatment duration is 7 days. Care should be taken to not discontinue therapy prematurely.
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 dexamethasone and levofloxacin eye drops. The length of treatment can depend on the patient's risk factors and outcome of surgery and must be determined by the doctor according to slip-lamp microscopic findings and depending on the severity of the clinical picture. A follow-up treatment with steroid eye drops should not exceed 2 weeks.
Additional Dosage Information
Missed dose
If one dose is missed, treatment should continue with the next dose as planned.
Administration
For ocular use only.
Contraindications
Children under 18 years
Varicella
Breastfeeding
Herpes simplex keratitis
Mycobacterial eye infection
Ocular herpes simplex infection
Ocular infection
Pregnancy
Precautions and Warnings
Hepatic impairment
Renal impairment
Advise patient blurred vision may affect ability to drive/operate machinery
Consult national/regional policy on the use of anti-infectives
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Contains benzalkonium chloride
Administer other ophthalmic products at least 15 minutes apart
To reduce systemic absorption compress lacrimal sac during administration
If visual disturbances occur, perform ophthalmic evaluation
Monitor intra-ocular pressure
Contains phosphate: Risk of calcification in existing notable cornea damage
Discontinue at the first sign of tendon inflammation
Discontinue if active infection develops
Prolonged use may result in ocular infections
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if hypersensitivity reactions occur
Advise patient to avoid touching the eye/other surfaces with container tip
Advise patient to wash hands before and after use
Contact lenses should not be worn during treatment
Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension/glaucoma but this is unlikely when dexamethasone and levofloxacin is used for the recommended treatment period.
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 dexamethasone and levofloxacin.
Treatment should be progressively discontinued if Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone occur after intensive or continuous use in predisposed patients. These patients include children and patients treated with CYP3A4 inhibitors.
Pregnancy and Lactation
Pregnancy
Dexamethasone and levofloxacin is contraindicated during pregnancy.
The manufacturer advises that dexamethasone and levofloxacin is not recommended during pregnancy and especially during the first three months. Animal studies of corticosteroids have shown reproductive toxicity and teratogenic effects. At the time of writing there are no or limited data from the use of dexamethasone and levofloxacin in pregnant women. Corticosteroids cross the placenta. Prolonged or repeated corticosteroid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation, lower birth weight and risk for high blood pressure, vascular disorders and insulin resistance in the adulthood. Infants should be carefully observed for signs of hypoadrenalism.
Lactation
Dexamethasone and levofloxacin is contraindicated during breastfeeding.
The manufacturer recommends a decision must be made whether to discontinue breastfeeding or to discontinue dexamethasone and levofloxacin treatment taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women. Systemic corticosteroids and levofloxacin are excreted into human milk. No data is available, to indicate whether relevant amounts of dexamethasone are transferred into human breast milk and which are capable of producing clinical effects in the infant. A risk to the suckling child cannot be excluded.
Side Effects
Abnormal sensation in eye
Adrenal suppression
Anaphylaxis
Blurred vision
Burning and stinging of the eyes
Conjunctival chemosis
Conjunctival follicles
Conjunctival hyperaemia
Conjunctival papillae
Conjunctivitis
Corneal changes
Corneal deposits
Corneal oedema
Corneal perforation
Corneal ulcer
Cushing's syndrome
Dryness of eyes
Dysgeusia
Eye irritation
Eyelid erythema
Eyelid oedema
Facial oedema
Glaucoma
Headache
Hypersensitivity reactions
Impaired vision
Increased intra-ocular pressure
Keratopathy
Laryngeal oedema
Mucous strand
Mydriasis
Ocular allergy
Ocular burning
Ocular discomfort
Ocular hypertension
Ocular itching
Ocular pain
Opportunistic infections
Photophobia
Posterior subcapsular cataracts
Pruritus
Ptosis
Rash
Rhinitis
Sticky eyelid
Tendon inflammation
Tendon rupture
Uveitis
Wound healing retarded
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2022
Reference Sources
Summary of Product Characteristics: Ducressa 1mg/ml and 5mg/ml eye drops. Santen UK Limited. Revised February 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.