Fucithalmic^® (Drops) Instructions for Use

Marketing Authorization Holder

Amdipharm, Limited (Ireland)

Manufactured By

LEO Laboratories, Limited (Ireland)

ATC Code

S01AA13 (Fusidic acid)

Active Substance

Fusidic acid (Rec.INN registered by WHO)

Dosage Form

Fucithalmic®

Eye drops 1%: 5 g tube with tip

Dosage Form, Packaging, and Composition

Eye drops in the form of a viscous suspension, white or almost white in color.

Excipients: benzalkonium chloride – 0.11 mg, disodium edetate – 0.5 mg, mannitol – 50 mg, carbomer – 5 mg, sodium hydroxide – q.s., purified water – up to 1 g.

5 g – aluminum tubes (1) with a polyethylene tip – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for topical use in ophthalmology

Pharmacotherapeutic Group

Polycyclic structure antibiotic

Pharmacological Action

An antimicrobial drug, an antibiotic of a polycyclic structure, belongs to the fusidines group. The mechanism of action is associated with the disruption of protein synthesis in the bacterial cell. By blocking the elongation factor G, it prevents its binding to ribosomes and guanosine triphosphate, which interrupts the release of energy necessary for protein synthesis and leads to the death of the bacterial cell.

Active against microorganisms most commonly causing eye infections: Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae.

Enterobacteriaceae and Pseudomonas spp. are resistant to the action of fusidic acid.

There are no reports of cross-resistance to fusidic acid.

Pharmacokinetics

Absorption and Distribution

The drug formulation (viscous eye drops) provides prolonged contact with the conjunctiva and sufficient concentration of fusidic acid in the tear fluid when applied twice a day.

At 1, 3, 6, and 12 hours after a single application of Fucithalmic^®, the average concentration of fusidic acid in the tear fluid is 15.7; 15.2; 10.5; and 5.6 µg/ml, respectively. In the intraocular fluid, a concentration of fusidic acid equal to 0.3 µg/ml (after a single application) and 0.8 µg/ml (after repeated application) is achieved within 1 hour after application and is maintained for at least 12 hours, while fusidic acid is not detected in the blood serum.

Elimination

It is eliminated mainly with bile. Urinary excretion is less than 1% of the dose.

Indications

Treatment of bacterial eye infections caused by microorganisms sensitive to the drug

• Conjunctivitis;
• Blepharitis;
• Keratitis;
• Dacryocystitis.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye twice daily.

Administer the drops in the morning and evening for a standard treatment course of seven days.

This regimen applies to both adults and children from 0 years of age.

Ensure the tube is tightly closed after each use to prevent contamination.

Do not allow the tip of the tube to contact the eye, eyelids, or any other surface.

If treating bilateral infection, apply one drop to each eye, maintaining the twice-daily schedule.

Continue treatment for the full prescribed duration, even if symptoms improve earlier.

If no clinical improvement is observed after several days of therapy, re-evaluate the patient.

Do not wear contact lenses during the treatment period.

If vision becomes blurred immediately after instillation, wait until full vision clears before driving or operating machinery.

Adverse Reactions

Definition of the frequency of adverse reactions: very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10,000, < 1/1000), very rare (< 1/10,000, including isolated reports).

Eye disorders frequency unknown – periorbital edema.

Allergic reactions frequency unknown – itching, rash, urticaria, angioedema.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Fucithalmic^® can be used as prescribed by the attending physician if the expected therapeutic effect outweighs the potential risk of side effects in the fetus or child.

Pediatric Use

Can be used according to indications following the dosing regimen.

Special Precautions

Long-term use of an antimicrobial drug may lead to the development of superinfection caused by microorganisms resistant to this drug, including fungi.

The tube must be closed after each use. Do not touch the tip of the tube to the eye.

Therapy with Fucithalmic^® should be discontinued if symptoms of hypersensitivity to the drug appear.

It is not recommended to wear contact lenses during the use of Fucithalmic^®. Microcrystals of fusidic acid may cause scratches on the lenses or cornea.

Effect on the ability to drive vehicles and operate machinery

If blurred vision occurs after instillation, refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions until vision is restored.

Overdose

No cases of drug overdose have been reported.

Drug Interactions

No data on drug interactions are available.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

After opening the tube, the drug should be used within 1 month.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.