How should amphotericin B be reconstituted and prepared as 0.15% (1.5 mg/mL) eye drops for treating fungal keratitis?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 25, 2026View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Reconstitution of Amphotericin B Eye Drops for Fungal Keratitis

Reconstitute amphotericin B deoxycholate to 0.15% (1.5 mg/mL) by diluting the parenteral formulation (typically Fungizone®) with sterile water, though this extemporaneous preparation is stable for only 7 days refrigerated and causes significant ocular irritation. 1, 2

Standard Reconstitution Protocol

Using Amphotericin B Deoxycholate (Fungizone®)

  • Start with the parenteral formulation containing 50 mg amphotericin B deoxycholate per vial 2

  • Reconstitute the vial with 10 mL sterile water for injection (not saline, as it causes precipitation) to create a 5 mg/mL stock solution 2

  • Further dilute to 0.15% (1.5 mg/mL) by taking 3 mL of the 5 mg/mL stock and adding 7 mL sterile water to achieve a final 10 mL volume at the target concentration 1, 2

  • Store refrigerated at 2-8°C and discard after 7 days, as stability beyond this period is not guaranteed 2

  • Administer hourly for the first 24-48 hours if there is no response to initial empirical therapy (econazole 1%), then taper based on clinical response 1

Critical Limitations of Standard Preparation

  • Deoxycholate causes significant corneal irritation and reduces patient compliance, which is a major drawback of extemporaneous preparations from Fungizone® 3

  • Short shelf-life of only 1 week refrigerated limits practical use in outpatient settings 3

  • Particle aggregation can occur, reducing drug availability and potentially causing mechanical irritation 2

Superior Alternative Formulations (When Available)

Gamma-Cyclodextrin Complex

  • Mix 0.1% amphotericin B with 10% γ-cyclodextrin in sterile water to create a true solution rather than suspension 2

  • This formulation maintains sterility, acceptable osmolarity, pH, and particle size for ophthalmic use over 30 days at room temperature 2

  • Antifungal activity is 35% higher against Candida albicans compared to Fungizone®-based preparations 2

  • Chemical stability is superior to the reference suspension, making this the preferred formulation when cyclodextrin is available 2

Liposomal Amphotericin B (AmBisome®)

  • Reconstitute AmBisome® to 0.5% (5 mg/mL) by adding sterile water to the vial per manufacturer instructions 3

  • This preparation remains stable for 6 months at room temperature or refrigerated, with hydrodynamic diameter maintained at 108 ± 30 nm and drug content between 94-107% 3

  • Liposomal formulation eliminates deoxycholate-related irritation and improves patient tolerance 3

  • Note: This is a higher concentration (0.5%) than standard (0.15%) but may be diluted if needed, though the 0.5% concentration has been validated for stability 3

Dosing and Administration

  • Apply 1-2 drops to affected eye(s) every hour around the clock for severe fungal keratitis until clinical improvement, then taper to every 2-4 hours 1, 4

  • Continue treatment for at least 4-6 weeks with duration dependent on resolution of lesions determined by repeated ophthalmological examinations 5

  • For severe cases unresponsive to topical therapy alone, consider adjunctive subconjunctival amphotericin B injections (0.5-1.0 mg in 0.5 mL sterile water) to ensure adequate drug penetration 4

Common Pitfalls to Avoid

  • Never use normal saline as diluent for amphotericin B deoxycholate, as it causes immediate precipitation; only sterile water should be used 2

  • Do not confuse intravitreal dosing (5-10 μg/0.1 mL) with topical eye drop concentrations (1.5 mg/mL), as intravitreal overdosing causes severe retinal toxicity 5

  • Warn patients about expected pain and irritation with deoxycholate-based preparations to improve compliance 3, 4

  • Ensure proper storage and dating of extemporaneous preparations, as expired formulations lose potency and may harbor microbial contamination 2, 3

  • Consider ophthalmology consultation for all cases of fungal keratitis, as these infections can rapidly progress to corneal perforation and require close monitoring 5

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.