Fusidic Acid- Ophthalmic

Pharmacologic Category

Antibiotic, Miscellaneous; Antibiotic, Ophthalmic

Dosing: Adult

Ophthalmic infections/conjunctivitis: Ophthalmic: Instill 1 drop into the conjunctival sac of each eye every 12 hours for 7 days; reassess if infection has not resolved after 7 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Ophthalmic infections/conjunctivitis: Children ≥2 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Note: Not approved in the US

Ophthalmic infections/conjunctivitis: Treatment of superficial infections of the eye and conjunctiva caused by susceptible organisms (Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae) in adults and pediatric patients ≥2 years of age.

Administration: Ophthalmic

Tilt head back, pull down lower eyelid and instill drop into eye. Wash hands before and after instillation; avoid touching tip of applicator to eye or other surfaces. Contact lenses should not be worn during therapy.

Administration: Pediatric

Ophthalmic: For ophthalmic use only. Contact lenses should not be worn during therapy. Wash hands before and after instillation. Tilt head back, pull down lower eyelid and instill drop into eye. Avoid touching tip of applicator to eye or other surfaces.

Storage/Stability

Store at 2°C to 25°C (36°F to 77°F). Discard each multi-dose tube 28 days after opening.

Contraindications

Hypersensitivity to fusidic acid or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in superinfection (including fungal infections). Discontinue use if superinfection occurs; evaluate and treat appropriately.

Special populations:

• Neonates: Not indicated for use in neonatal conjunctivitis.

Dosage form specific issues:

• Benzalkonium chloride: Multidose vials contain benzalkonium chloride; may be absorbed by contact lenses.

Other warnings/precautions:

• Appropriate use: For topical use only; do not inject into the eye. Discontinue use if irritation (other than transient stinging upon administration) develops.

• Contact lenses: Contact lenses should not be worn during treatment.

Pregnancy Considerations

Adverse effects were not observed in animal reproduction studies. Fusidic acid crosses the placenta during systemic administration.

Breast-Feeding Considerations

Fusidic acid is present in breast milk following systemic administration. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Adverse Reactions

1% to 10%: Ophthalmic: Eye irritation (3%; transient)

<1%: Abscess (eyelid), asthenopia, blurred vision (temporary), burning sensation of eyes (transient), chest infection, conjunctival abnormalities (cobblestone appearance of the conjunctival sulcus), decreased appetite, exacerbation of eye infection (conjunctivitis), eye pain, eyelid edema, headache, lacrimation (transient), local hypersensitivity reaction, oral candidiasis, skin rash, sticky sensation of eye, tonsillitis, urinary incontinence, urticaria, vomiting

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Product Availability

Not available in the US

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Ophthalmic:

Fucithalmic: 1% ([DSC])

Fucithalmic: 1% (3 g, 5 g) [contains benzalkonium chloride]

Anatomic Therapeutic Chemical (ATC) Classification

• S01AA13

Generic Available (US)

Yes

Mechanism of Action

Inhibits protein synthesis by blocking aminoacyl-tRNA transfer to protein in susceptible bacteria.

Pharmacodynamics/Kinetics

Absorption: Good; lacrimal fluid concentrations range 15.7-40 mcg/mL and 1.4 mcg-5.6 mcg/mL at 1 hour and 12 hours respectively after administration. Median concentrations of 0.3 mcg/mL (single dose) and 0.8 mcg/mL (repeated dosing) were maintained in aqueous humor over 12 hours (Hansen, 1985).

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Fusidate Sodium; Fusidic Acid Hemihydrate; Sodium Fusidate

References

Fucithalmic (fusidic acid) [product monograph]. Brantford, Ontario, Canada: Methapharm; October 2019.

Hansen S. Intraocular penetration of fusidic acid with topical fucithalmic. Eur J Drug Metab Pharmacokinet. 1985;10(4):329-331.[PubMed 3830720]

Brand Names: International

Fucidin (IT); Fucidine (ES); Fucithalmic (AT, BB, BE, BH, CH, CL, CO, DE, DK, EC, EE, EG, ES, FI, HK, IE, IL, JO, KW, LB, LK, LU, MT, MY, NL, NO, NZ, PH, PK, PT, QA, RO, RU, SA, SE, TH, TR, ZA); Fucithalmmic (CZ)

Last Updated 8/28/20