RESTASIS 0.05% EYE DROPS 30/UNIDOSE

Indications

Approved Uses

To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye).

Off-Label Uses

Off-label ophthalmic uses include vernal/atopic keratoconjunctivitis, ocular graft-versus-host disease, and prevention/treatment of corneal graft rejection (e.g., post-keratoplasty) in selected patients under specialist care.

Dosage & Administration

Dosing by Condition

Keratoconjunctivitis sicca (dry eye disease): Instill 1 drop in each affected eye twice daily, approximately 12 hours apart, continued as directed for chronic disease control.

Initial Dose

Instill one drop in each affected eye twice daily, approximately 12 hours apart.

Maintenance Dose

Instill one drop in each affected eye twice daily, approximately 12 hours apart.

Maximum Dose

1 drop in each affected eye twice daily (about 12 hours apart).

Dose Adjustment Notes

No dose adjustment is recommended for renal or hepatic impairment because systemic exposure after ophthalmic use is minimal; if concomitant artificial tears/other eye drops are used, administer at least 15 minutes apart.

How to Take

For single-use (unidose) RESTASIS 0.05% ophthalmic emulsion: Wash hands; invert the vial a few times to obtain a uniform white emulsion (do not vigorously shake); twist off tab; instill 1 drop into the affected eye(s) twice daily about 12 hours apart; avoid touching tip to eye/skin; if using other ophthalmic products, separate by at least 15 minutes; remove contact lenses before dosing and reinsert after 15 minutes; discard the vial immediately after use (do not save остатки). Nasolacrimal occlusion for 1-2 minutes may be used to reduce systemic absorption.

How to Prepare

Invert the single-use vial a few times (gentle inversion) to obtain a uniform, white, opaque emulsion before use; no reconstitution is required.

Side Effects

Common Side Effects

Ocular burning sensation, eye pain, stinging on instillation, conjunctival hyperemia, ocular discharge, epiphora, foreign body sensation, pruritus, visual disturbance (blurring)

Side Effect Frequency

Very common (>10%): ocular burning/stinging on instillation (commonly reported around ~17%). Common (1-10%): conjunctival hyperemia, eye pain, foreign body sensation, pruritus, epiphora, blurred vision/visual disturbance, ocular discharge.

Safety & Warnings

Contraindications

Known hypersensitivity to ciclosporin or any component of the formulation; avoid use in patients with active ocular infection.

Warnings & Precautions

Ophthalmic use only; avoid contamination (do not touch vial tip); remove contact lenses before use and reinsert after 15 minutes; discard each single-use vial after opening; avoid/use caution in active ocular infection; onset of benefit may take weeks to months (often 3-6 months).

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically meaningful systemic drug interactions expected (minimal systemic absorption); if using other ophthalmic products, separate administration by at least 15 minutes.

Interaction Severity

Clinically significant systemic drug interactions are not expected due to minimal systemic absorption; practical interaction is with other ophthalmic products (including artificial tears/NSAID drops) where separation by ≥15 minutes is advised to prevent dilution/washout rather than a true pharmacokinetic interaction.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Preparation Instructions

Invert the single-use vial a few times (gentle inversion) to obtain a uniform, white, opaque emulsion before use; no reconstitution is required.

Stopping the Medicine

May be discontinued without taper; dry eye symptoms may recur-discuss with prescriber if stopping long-term therapy or if symptoms worsen.

Patient Counseling

Use 1 drop in each affected eye twice daily ~12 hours apart; invert vial a few times to mix; avoid touching the tip; remove contact lenses and reinsert after 15 minutes; separate from other eye drops by ≥15 minutes; expect transient burning/stinging; improvement may take 3-6 months; discard each unidose vial immediately after use; store below 30°C in original packaging.

Monitoring Requirements

No routine systemic monitoring is required; monitor clinically with periodic ophthalmic assessment of symptom response, ocular surface status, and tolerability (e.g., burning, redness).

Pharmacology

Mechanism of Action

Calcineurin inhibitor: binds cyclophilin and inhibits calcineurin, reducing T-cell activation and inflammatory cytokine signaling on the ocular surface, thereby increasing tear production in dry eye disease.

Onset of Action

Clinical improvement may begin after several weeks but commonly requires ~3 months; maximal tear-production benefit often takes 3-6 months of continuous twice-daily use.

Duration of Effect

Benefit is maintained only with continued twice-daily use; symptoms/tear production improvements may diminish after discontinuation.

Half-Life

Not applicable / not established for ophthalmic ciclosporin (Restasis) because systemic absorption is negligible and blood levels are typically undetectable; therefore a meaningful systemic half-life cannot be determined.

Bioavailability

Systemic absorption is minimal/negligible after ophthalmic administration; blood levels are typically below quantitation (around ≤0.1 ng/mL in studies).

Metabolism

For the ophthalmic product: not clinically relevant (negligible systemic absorption); if any drug is systemically absorbed, ciclosporin is primarily metabolized by hepatic CYP3A4 (and is a P-gp substrate/inhibitor).

Excretion

Not clinically relevant because systemic exposure is negligible; if any fraction is absorbed systemically, cyclosporine is primarily eliminated via biliary/fecal excretion with minimal renal excretion.

Protein Binding

Not clinically relevant for ophthalmic Restasis due to negligible systemic absorption; for systemic ciclosporin, protein binding is high (approximately >90%).

Product Information

Available Dosage Forms

Eye drops, emulsion (ophthalmic emulsion) in single-use unidose vials (0.4 mL) - for this SFDA-registered product/pack.

Composition per Dose

Each 0.4 mL unidose vial: ciclosporin 0.2 mg (as 0.05% w/v emulsion) in castor oil/polysorbate 80 emulsion base

OTC Alternatives

Preservative-free artificial tears/lubricants (e.g., carboxymethylcellulose, hypromellose, sodium hyaluronate) and lubricating ointments/gels for symptomatic relief.

Target Organ

Eye

Preservative Free

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 16-05-2026