Use: Furosemide is used to treat edema associated with a number of disorders, including congestive heart failure, nephrotic syndrome, and
hepatic cirrhosis; it also has been used as an adjunct in the treatment
of acute pulmonary edema.
Packaging: Package in tight, light-resistant containers.1
Labeling: Keep out of reach of children. Shake well. Store in a refrigerator. Discard after ____ [time period].Stability: A beyond-use
date of 14 days when stored in a refrigerator may be used for this
preparation made with SyrSpend SF Alka or syrup NF.1,2
Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic
properties/pourability, physical observation, and physical stability
(discoloration, foreign materials, gas formation, mold growth).3
Discussion: Furosemide (Lasix, Frusemide, C12H11ClN2O5S, MW 330.74) is a sulfonamide-derivative loop diuretic that inhibits the Na-K-2Cl
cotransporter in the thick ascending limb of the loop of Henle.
Furosemide is a fine, white to slightly yellow, odorless, practically
tasteless, crystalline powder with a pKa of 3.9, and it melts at about
203°C-205°C with decomposition. Chemically, furosemide is
4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is
practically insoluble in water or dilute acids. It is freely soluble in
solutions of alkali hydroxides and sparingly soluble in alcohol.
Furosemide is subject to photodegradation by several mechanisms;
consequently, it should be preserved in light-resistant containers. This
photodegradation is minimized at pH 7, and the degradation rate
increases as the pH becomes more acidic or basic. Furosemide should be
packaged in well-closed containers and stored at room temperature, with
excursions permitted between 15°C and 30°C, and it should be protected
from light. The injection has a pH in the range of 8.0 to 9.3 and
contains not more than 3.6 USP EU per mg of furosemide.1
If the source of the active drug is tablets, Lasix tablets for oral administration also contain lactose monohydrate NF, magnesium stearate
NF, starch NF, talc USP, and colloidal silicon dioxide NF. The white
Lasix tablets for oral administration are available in dosage strengths
of 20, 40, and 80 mg. Tablets, if used, must be thoroughly pulverized
before incorporation into the vehicle. To obtain 1 gram of the drug from
tablets, from 12.5 to 50 tablets may be required depending on which
strength is used. The 80-mg strength is preferred; obviously, the use of
fifty 20-mg tablets would yield a large quantity of powder, resulting
in some thickening of the preparation.
SyrSpend SF Alka is a dry powder for reconstitution. SyrSpend SF Alka provides a reasonable solution for preparing oral liquid dosage
forms with acid-labile active pharmaceutical ingredients, including
furosemide. It is preservative-free and alcohol-free and is suitable for
problematic patients, such as neonates. SyrSpend SF Alka also allows
for direct compounding in the dispensing container for maximum
efficiency if the prescription or order requires 100 mL. Smaller or
larger volumes may be feasible with some manipulation. SyrSpend SF Alka
is buffered to pH levels 7 for acid-labile active pharmaceutical
ingredients. It is preservative-free and unflavored, and it is available
in a dispensing container with preweighed powder to make 100 mL
(contains 6.3 g powder) or 200 mL (contains 12.6 g powder).4
Syrup (simple syrup) is a clear, sweet vehicle used as a sweetening agent and as the base for many flavored and medicated syrups. It
contains 85% w/v sucrose in water and has a specific gravity of not less
than 1.30. Syrup is generally self-preserving as long as the sucrose
concentration is maintained sufficiently high. However, syrup NF
contains a preservative unless it is used when freshly prepared. It is
preferable to prepare syrup NF without the use of heat, but it may be
prepared with boiling water. It should be stored in tight containers,
preferably in a cool place. The pH is in the range of 6.5 to 7.5
