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Measure the volume of fluoxetine solution with a graduated cylinder.
Add vehicle to the graduated cylinder to achieve the total volume indicated above.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Alternatives — May substitute vehicle with deionized water, simple syrup BP, aromatic elixir USP, or grape-cranberry drink.
Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).
Labeling Requirements — Extemporaneously compounded preparation. For oral use only. Store at room temperature or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 56 days.
Study Container Type — Amber glass bottle
Referenced Manufacturers — Fluoxetine hydrochloride solution (Eli Lilly and Co); deionized water, simple syrup, aromatic elixir (not specified); grape-cranberry drink (Cran-Grape, Ocean Spray Cranberries).
Stability-Indicating Study — Yes
Commercially available as a 4-mg/mL solution — Use extemporaneously prepared formulation only when a more dilute syrup is desired.
Peterson JA, Risley DS, Anderson PN, et al.Stability of fluoxetine hydrochloride in fluoxetine solution diluted with common pharmaceutical diluents. Am J Hosp Pharm. 1994;51(10):1342–1345.
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