I-Lube

I-Lube

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Contents
Polyvinyl alcohol, povidone.
Description
10 ml contains: Polyvinyl alcohol 1.4% w/v, Povidone 0.6% w/v and Benzalkonium chloride (as preservative) 0.01% w/v.
10ml solution filled in 10ml labeled LDPE vial provided with spike cap in a carton.
Action
Pharmacology: Pharmacodynamics: The product does not contain any active pharmacological compounds. Due to their physical properties, non-irritant water soluble polymers can be used for moistening and lubrication of the ocular surface.
Pharmacokinetics: The lower molecular weight forms of Povidone are excreted in the urine and 60 to 70% of a dose is excreted in 1 to 3 days; small amounts are excreted in the faeces. Relatively large size of the povidone molecule, penetration through the cornea is unlikely.
Indications/Uses
For the temporary relief of prevention of further discomfort due to minor eye irritations and symptoms related to dry eyes.
Dosage/Direction for Use
Instill one or two drops in the affected eye(s) as needed.
MODE OF USE: Tighten the cap on the nozzle.
The spike in the cap will pierce the tip of the vial.
Dispense drops with gentle pressure.
Replace the cap after every use.
Route of administration: Ocular.
Overdosage
Non Applicable.
Contraindications
Sensitivity to any of the ingredient is a contraindication. Not for use with soft contact lenses.
Special Precautions
The dropper tip should not be allowed to touch any surface. If there is eye pain, changes in vision, continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours, discontinue use & consult a doctor. If color of the solution changes or becomes cloudy, do not use.
Use In Pregnancy & Lactation
There are no adequate data from the use of I lube eye drops in pregnant women. Patients should contact their doctor prior to starting I lube eye drops during pregnancy and lactation.
Side Effects
Common: Mild, transient burning or sticky sensation.
Very rare: Irritation or hypersensitivity reactions.
Drug Interactions
If the patient instill other medication(s) into the eyes (e.g. for the treatment of glaucoma), there must be an interval of at least 5 minutes between medications. I Lube should always be instilled last.
Caution For Usage
Special precautions for disposal and other handling: Discard 1 month after opening.
Incompatibilities:
High salt concentrations, e.g. of sodium sulphate in cold and of sodium chloride in warm conditions, can result in precipitation of povidone. Depending on the ionic strength of the solution methyl- and propylhydroxybenzoates easily form complexes with povidone.
Storage
Store the vial well closed at a temperature below 30°C.
Shelf-Life: 24 months.
ATC Classification
S01XA - Other ophthalmologicals ; Used in ophthalmic preparations.
Presentation/Packing
Eye drops (a clear, colorless solution) 10 mL.
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