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
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