Spironolactone Manufacturing Worksheet

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UConn Health - John Dempsey Hospital
Department of Pharmacy
860-679-7627
Drug Compounding Information Sheet
Drug Preparation:
Spironolactone Oral Suspension 5mg/mL (200mL)
(Aldactone) (sugar-free formulation)
1. Compounding procedure if not commercially available: **** Oral
Suspension****
Ingredients: Spironolactone 25mg Tablets # 40
Ora-Sweet sugar free – 100ml
Ora-Plus – 100 ml
 Mix 1:1 ratio of Ora-Sweet Sugar Free and Ora-Plus together.
 Place tablets in mortar and crush to fine powder.
 Add approximately 40mL of vehicle, and mix to a uniform paste.
 Add the vehicle in geometric proportions almost to volume and mix thoroughly after
each dilution.
 Transfer the contents of mortar to the calibrated bottle.
 Add enough vehicle to bring the final volume to 200mL.
2. Compatibility: other compatible levigating agents include: cherry syrup, cologel
(formulation will contain sugar). In addition, small amounts of glycerin can be used
during levigation.
3. Storage/Stability:
Shake well Refrigerate
Expires: 60 days
Protect from Light
4. Clinical Information:
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Dose & Administration: Neonates 1 to 3mg/kg per dose (q24hrs)
Indication: potassium sparing diuretic, used in edema with excessive aldosterone
excretion, HTN, primary hyperaldosteronism, hypokalemia, cirrhosis of liver with
ascites or edema
Contraindications: Hypersensitivity to spironolactone, hyperkalemia, renal failure,
anuria
5. Adverse Effects: hyperkalemia, rash, vomiting, diarrhea, paresthesias, headache,
drowsiness
6. References: Old manufacturing record, Drug Information Handbook 7th edition,
Micromedex-Drugdex, NeoFax
Spironolactone 5mg/mL Suspension (Updated 5/28/2014)
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