( For the use of a Registered Medical Practitioner or a Hospital or Laboratory Only)
LOCFRESH Eye Drops
Composition:
Sodium Carboxymethyl-Cellulose IP……………………………..0.5% w/v
Stabilized Oxychloro Complex (as preservative)…………0.0075% w/v
Sterile Aquaeous base………………………...........................q.s.
Therapeutic Indications
Carboxymethyl-Cellulose Sodium 0.5% eye drops are used as a lubricant to relieve irritation and discomfort due to dryness of the eyes or due to exposure of the eyes to wind or sun, for the treatment of the symptoms of dry eye and as a protectant against further irritation.
Posology and Method of Administration
Recommended Dosing: Instill one to two drops in the affected eye(s) as needed.
Paediatric population
The safety and efficacy of carboxymethyl cellulose 0.5% eye drops in children and adolescents have been established by clinical experience, but no clinical trial data are available. The dosage recommended in adults is recommended in the paediatric population.
Contraindications
Hypersensitivity to sodium carboxymethyl cellulose or to any of the excipients.
Special Warnings and Precautions for Use
To avoid contamination do not touch tip of container to any surface. Replace cap after using. If you experience eye pain, changes in vision, continued redness or irritation of the eye and if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. If solution changes colour or becomes cloudy, do not use. Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or consult your physician.
Drug Interactions
None known.
Use in Special Population
Pregnancy: Due to the negligible systemic exposure and the lack of pharmacological activity carboxymethyl cellulose 0.5% eye drops can be used during pregnancy.
Lactation: Due to the negligible systemic exposure and the lack of pharmacological activity carboxymethyl cellulose 0.5% eye drops can be used during breast-feeding.
Undesirable Effects
Common Eye disorders: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.
Immune System Disorders: Hypersensitivity including eye allergy.
Eye Disorders: Blurred vision, eye discharge, lacrimation increased, ocular hyperemia.
Injury, Poisons and Procedural Complications: Superficial injury of eye (from the vial tip touching the eye
during administration) and/or corneal abrasion.
Overdose
Accidental overdose will present no hazard.
Pharmacological Properties
Pharmacodynamic Properties
Carboxymethylcellulose Sodium has no pharmacological effect. Carboxymethylcellulose Sodium has a high viscosity, resulting in an increased retention time on the eye.
The excipients in Carboxymethylcellulose Sodium 0.5% eye drops were chosen to mimic the electrolyte constitution of tears.
Pharmacokinetic Properties
Due to the high molecular weight (approximately 90,000 Daltons), Carboxymethylcellulose Sodium is unlikely to penetrate the cornea.
Storage and handling instructions
Do not store above 25°C.