OPTIFUCIN FUSIDIC ACID 1% EYE DROPS VISCOUS 5GM

Indications

Approved Uses

Bacterial conjunctivitis (acute bacterial conjunctivitis) caused by susceptible organisms.

Off-Label Uses

No well-established off-label uses to routinely recommend; use should be limited to clinician-directed indications (e.g., other superficial ocular infections only if specifically prescribed).

Dosage & Administration

Dosing by Condition

Bacterial conjunctivitis: Instill 1 drop into the affected eye(s) twice daily (approximately every 12 hours) for 7 days (or as prescribed).

Initial Dose

1 drop into affected eye(s) twice daily

Maintenance Dose

1 drop into affected eye(s) twice daily for 7 days

Maximum Dose

1 drop into the affected eye(s) twice daily; do not extend beyond 7 days without reassessment.

Children's Dosage

Children ≥2 years: same as adult dosing - 1 drop twice daily. Not recommended in children under 2 years due to insufficient data

Dose Adjustment Notes

No dose adjustment required for renal or hepatic impairment due to negligible systemic absorption

How to Take

Wash hands. Tilt head back and pull down the lower eyelid to form a pocket. Instill 1 drop into the conjunctival sac without touching the dropper tip to the eye/skin/any surface. Close the eye gently for 1-2 minutes; optional nasolacrimal occlusion (press inner corner near the nose) to reduce systemic absorption. Recap immediately.

How to Prepare

N/A - ready-to-use viscous eye drops (no reconstitution or dilution required).

Side Effects

Common Side Effects

Transient burning/stinging or pain on instillation, eye irritation/discomfort/itching, watering (lacrimation), and temporary blurred vision.

Side Effect Frequency

Common (≥1% to <10%): transient blurred vision after instillation; burning/stinging/eye irritation or discomfort; pruritus; increased lacrimation. Uncommon (≥0.1% to <1%): eyelid oedema/dermatitis; hypersensitivity reactions such as rash/urticaria. Rare: angioedema or more severe allergic reactions.

Safety & Warnings

Contraindications

Hypersensitivity to fusidic acid or to any excipients in the formulation.

Warnings & Precautions

Ophthalmic use only; avoid contaminating the dropper tip; do not wear contact lenses during treatment; transient blurred vision may occur; prolonged/recurrent use may cause overgrowth/resistance-stop and seek advice if hypersensitivity occurs.

Age Restriction

Use in children ≥2 years is established; for <2 years use only if prescribed/clinically indicated (not routinely recommended due to limited data).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

No clinically significant drug interactions expected with ophthalmic use.

Interaction Severity

No clinically significant drug interactions expected with ophthalmic fusidic acid.

Food Interaction

No known food interactions (ophthalmic use; minimal systemic absorption).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children ≥2 years: same as adult dosing - 1 drop twice daily. Not recommended in children under 2 years due to insufficient data

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Preparation Instructions

N/A - ready-to-use viscous eye drops (no reconstitution or dilution required).

Missed Dose

Instill the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and continue the regular schedule. Do not double doses.

Stopping the Medicine

Complete the prescribed course; typically 1 drop twice daily for 7 days, and do not stop early even if symptoms improve unless advised by a clinician.

Overdose

Overdose is unlikely; if excessive instillation causes irritation, rinse with water/saline; if accidentally ingested, significant toxicity is unlikely but seek medical advice/supportive care as needed.

Patient Counseling

Use exactly as prescribed (typically 1 drop BID) and complete the course. Expect temporary blurred vision after instillation; avoid driving until vision clears. Do not touch the dropper tip; wash hands before/after. Avoid contact lenses during active infection and treatment unless the prescriber advises otherwise. Seek medical advice if symptoms worsen or do not improve within 2-3 days. Follow local product instructions for in-use discard period after opening.

Monitoring Requirements

No routine monitoring required; reassess if no clinical improvement after 3-5 days

Pharmacology

Mechanism of Action

Inhibits bacterial protein synthesis by interfering with elongation factor G (EF-G)-mediated translocation on the ribosome, leading mainly to bacteriostatic activity against susceptible organisms (notably many Gram-positive bacteria).

Onset of Action

Symptomatic improvement is often seen within 48-72 hours; reassess if no improvement or worsening by ~2-3 days.

Duration of Effect

Prolonged ocular surface residence from the viscous formulation supports sustained local levels allowing twice-daily dosing.

Half-Life

Systemic half-life is not clinically relevant for ophthalmic use; the viscous formulation prolongs ocular surface residence time.

Bioavailability

Systemic bioavailability is negligible after ophthalmic administration.

Metabolism

Minimal systemic absorption; if absorbed, fusidic acid undergoes hepatic metabolism (with subsequent biliary elimination).

Excretion

If systemically absorbed, fusidic acid is eliminated mainly via biliary excretion into feces (minor renal excretion).

Protein Binding

High plasma protein binding (~95-97%) based on systemic data (not clinically relevant for ophthalmic use).

Product Information

Available Dosage Forms

Eye drops, viscous (ophthalmic).

Composition per Dose

Each gram of viscous eye drops: 10 mg fusidic acid (as hemihydrate) in a carbomer gel base

OTC Alternatives

No OTC alternative - prescription required in Saudi Arabia

Target Organ

Eye

Preservative Free

No

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