CAROSPIR

For an equivalent dose, CAROSPIR results in 15 to 37% higher serum concentration compared to Aldactone tablets. Information about the dose proportionality of spironolactone tablets is limited and, based on the results of studies comparing the suspension to tablets, doses of suspension higher than 100 mg might result in spironolactone concentrations that could be higher than expected.

AbsorptionThe peak plasma concentration (Cmax) of spironolactone is reached 0.5 to 1.5 hours after dosing in hea...

14.1 Heart failure The Randomized Aldactone Evaluation Study (RALES) was a placebo-controlled, double-blind study of the effect of spironolactone on mortality in patients with highly symptomatic heart failure and reduced ejection fraction. To be eligible to participate, patients had to have an ejection fraction of ≤35%, NYHA Class III-IV symptoms, and a history of NYHA class IV symptoms within the last 6 months before enrollment. Patients with a baseline serum creatinine of >2.5 mg/dL or a recent increase of 25% or with a baseline serum potassium of >5.0 mEq/L were excluded. Follow-up visits a...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2) ] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3) ] Gynecomastia [see Warnings and Precautions (5.4) ] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7) ] The foll...

CAROSPIR is contraindicated for patients with the following conditions: Hyperkalemia Addison’s disease Concomitant use of eplerenone CAROSPIR is contraindicated in patients with ( 4 ) Hyperkalemia Addison’s disease Concomitant use of eplerenone

Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1 ) Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2 ) Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3 ) Gynecomastia: CAROSPIR can cause gynecomastia ( 5.4 ) 5.1 Hyperkalemia CAROSPIR can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassiu...

7 DRUG INTERACTIONS Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ) Lithium: Increased risk of lithium toxicity ( 7.2 ) NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of CAROSPIR ( 7.3 ) Digoxin: CAROSPIR can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ) Cholestyramine: Hyperkalemic metabolic acidos...