ARTELAC ADVANCED EYE DROPS 30/UNIDOSE

Indications

Approved Uses

Symptomatic treatment/relief of dry eye disease (dry eye syndrome) and associated ocular discomfort due to tear film instability (e.g., burning, irritation, foreign-body sensation).

Off-Label Uses

Adjunctive lubrication for contact lens-related dryness (only if compatible with lens wear per labeling), screen-associated dryness/visual display terminal symptoms, and supportive care in evaporative dry eye/meibomian gland dysfunction alongside primary therapies.

Dosage & Administration

Dosing by Condition

Dry eye disease: Instill 1 drop into the affected eye(s) as needed; typical use is 3-5 times daily, and may be used more frequently based on symptoms. Each unidose vial is single-use only.

Initial Dose

Instill one drop into the affected eye(s) as needed.

Maintenance Dose

1 drop into affected eye(s) 1-6 times daily based on symptom severity

Maximum Dose

No strict maximum dose is defined; use as needed according to symptoms (within labeled directions).

Children's Dosage

Suitable for use in children, but consult a physician before use. [14, 18]

Dose Adjustment Notes

No dose adjustment is required in renal or hepatic impairment.

How to Take

Wash hands. Open the single-dose unit (twist off cap). Tilt head back, pull down lower eyelid, instill 1 drop into the conjunctival sac without touching the tip to the eye/skin. Close the eye gently for ~1 minute. Discard the single-dose unit immediately after use (do not reuse).

Side Effects

Common Side Effects

Transient blurred vision after instillation; mild, short-lived eye irritation such as stinging/burning; foreign-body sensation; increased tearing or mild redness may occur.

Side Effect Frequency

Common: transient blurred vision and mild instillation-site discomfort (stinging/burning/irritation). Rare/very rare: hypersensitivity reactions; corneal calcification has been reported very rarely in patients with severely damaged corneas (class warning for phosphate-containing eye drops-verify excipients if present).

Safety & Warnings

Contraindications

Hypersensitivity to sodium hyaluronate, carbomer, medium-chain triglycerides, or any other ingredient in the formulation. [2, 18]

Warnings & Precautions

For ophthalmic use only; avoid touching the tip to prevent contamination; single-dose unit is single-use-discard after use; remove contact lenses before instillation and wait at least 15 minutes before reinsertion; transient blurred vision may occur-avoid driving/machinery until clear; discontinue and seek medical advice if pain, vision changes, or persistent/worsening redness/irritation occur.

Age Restriction

No specific age restriction is defined in the verified API data; pediatric use should be under clinician supervision.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant systemic drug interactions are expected; if used with other ophthalmic products, separate administrations by at least 15 minutes and use this viscous lubricant last.

Interaction Severity

MINOR: When using other ophthalmic products, separate administrations by at least 10-15 minutes; apply gels/ointments last.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Suitable for use in children, but consult a physician before use. [14, 18]

Elderly

Standard adult dosing

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Storage Conditions

Store below 25°C and keep in the original packaging/protect from light. Single-dose unit: use immediately after opening and discard any remaining solution; do not use an opened unit later.

Missed Dose

If using on a schedule, instill when remembered; if it is close to the next dose, skip and resume the usual schedule-do not double. If using PRN, use when symptoms occur.

Stopping the Medicine

Safe to stop anytime

Overdose

Overdose is unlikely with ophthalmic use; if excessive instillation causes irritation, rinse/flush the eye with clean water; accidental ingestion is expected to be low toxicity-provide supportive care and seek medical advice if symptoms occur.

Patient Counseling

For ophthalmic use only. Instill 1 drop into the affected eye(s) as needed for dry-eye symptoms. Wash hands before use; avoid touching the tip to the eye/skin/surfaces to prevent contamination. If using contact lenses, remove them before instillation and wait at least 15 minutes before reinsertion. Temporary blurred vision may occur-avoid driving/operating machinery until vision clears. If eye pain, persistent/worsening redness/irritation, or visual changes occur, stop use and seek medical advice. Store below 25°C; keep in original packaging. Single-dose unit: use immediately after opening and discard any remaining solution.

Monitoring Requirements

No routine monitoring required

Pharmacology

Mechanism of Action

Sodium hyaluronate provides viscoelastic lubrication and water retention on the ocular surface; carbomer increases viscosity and mucoadhesion to prolong residence time; medium-chain triglycerides supplement the lipid layer to reduce tear evaporation and stabilize the tear film.

Onset of Action

Immediate (within minutes) symptomatic relief after instillation.

Duration of Effect

Provides symptomatic relief for minutes to several hours; duration varies by severity of dry eye and environmental factors and may require repeat dosing.

Half-Life

Not clinically applicable; no meaningful systemic half-life, and local ocular residence time/half-life is not well established and depends on tear film dynamics.

Bioavailability

Not clinically applicable; systemic bioavailability is negligible/minimal after ophthalmic administration.

Metabolism

Not clinically applicable systemically; any absorbed fraction is minimal. Locally, sodium hyaluronate may be degraded by ocular surface enzymes/tear turnover; carbomer and medium-chain triglycerides primarily act locally with minimal systemic metabolism expected.

Excretion

Primarily cleared from the eye by tear turnover and nasolacrimal drainage; systemic excretion is not clinically relevant due to negligible absorption.

Protein Binding

Not applicable/clinically relevant due to negligible systemic absorption.

Product Information

Available Dosage Forms

Eye drops, solution (single-dose unit/unidose) for ophthalmic use.

Composition per Dose

Each 0.5 ml unit dose: Sodium hyaluronate 2.4 mg/g + Triglycerides medium chain 2 mg/g + Carbomer 0.625 mg/g

OTC Alternatives

Other artificial tears/lubricants (availability varies by country): carboxymethylcellulose, hypromellose, polyethylene glycol/propylene glycol, or sodium hyaluronate-based drops (including preservative-free options).

Target Organ

Eye

Preservative Free

Yes

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