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Carospir Generic Name & Formulations
Legal Class
Rx
General Description
Spironolactone 25mg/5mL; oral susp; banana flavor.
Pharmacological Class
Diuretic (K+ sparing).
How Supplied
Susp—118mL, 473mL
Manufacturer
Generic Availability
NO
Mechanism of Action
Spironolactone and its active metabolites act primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
Carospir Indications
Indications
To increase survival, manage edema, and to reduce hospitalization for heart failure (NYHA class III–IV) and reduced ejection fraction when used in addition to standard of therapy.
Carospir Dosage and Administration
Adult
Not therapeutically equivalent to Aldactone. If serum potassium ≤5.0mEq/L and eGFR >50mL/min/1.73m2: initially 20mg (4mL) once daily; may increase to 37.5mg (7.5mL) daily if tolerant. May decrease to 20mg (4mL) every other day if hyperkalemia develops. If eGFR 30–50mL/min/1.73m2: consider initiating at 10mg (2mL). If dose >100mg required, use another formulation.
Children
Not established.
Carospir Contraindications
Contraindications
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Carospir Boxed Warnings
Not Applicable
Carospir Warnings/Precautions
Warnings/Precautions
Increased hyperkalemia risk with renal impairment; monitor closely. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter; reduce dose or discontinue if hyperkalemia occurs. Monitor volume status, renal function, serum electrolytes, uric acid, and blood glucose periodically. Hepatic impairment. Elderly. Pregnancy: avoid. Nursing mothers.
Carospir Pharmacokinetics
Absorption
Peak plasma concentration is reached 0.5–1.5 hours after dosing.
High fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone by ~90%.
Distribution
Plasma protein bound: >90%.
Elimination
Renal (primarily), bile. Half-life: ~1–2 hours.
Carospir Interactions
Interactions
See Contraindications. Avoid K+-sparing diuretics, K+-supplements, K+-containing salt substitutes. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH, trimethoprim. Monitor for lithium toxicity. May be antagonized by NSAIDs, acetylsalicylic acid; monitor closely. Worsening renal function with concomitant nephrotoxic drugs (eg, aminoglycosides, cisplatin, NSAIDs). Potentiates digoxin; reduce digoxin dose by ~15–30%; monitor. May potentiate CYP2C8/CYP3A substrates (eg, repaglinide, midazolam, sirolimus, tacrolimus); may need to adjust dose of substrates. Caution with cholestyramine.
Carospir Adverse Reactions
Adverse Reactions
Gynecomastia, hyperkalemia, hypotension, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, hypovolemia, hyperglycemia, gastritis, diarrhea, cramping, nausea, vomiting, ataxia, drowsiness, headache, rash; neurologic impairment, coma.
Carospir Clinical Trials
See Literature
Carospir Note
Not Applicable
Carospir Patient Counseling
See Literature
Carospir Generic Name & Formulations
Legal Class
Rx
General Description
Spironolactone 25mg/5mL; oral susp; banana flavor.
Pharmacological Class
Diuretic (K+ sparing).
How Supplied
Susp—118mL, 473mL
Manufacturer
Generic Availability
NO
Mechanism of Action
Spironolactone and its active metabolites act primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
Carospir Indications
Indications
Edema associated with hepatic cirrhosis.
Carospir Dosage and Administration
Adult
Not therapeutically equivalent to Aldactone. Cirrhosis (initiate in hospital setting and titrate slowly): initially 75mg (15mL) daily in single or divided doses. If dose >100mg required, use another formulation. As sole agent for diuresis: administer for 5 days before increasing dose to obtain desired effect.
Children
Not established.
Carospir Contraindications
Contraindications
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Carospir Boxed Warnings
Not Applicable
Carospir Warnings/Precautions
Warnings/Precautions
Increased hyperkalemia risk with renal impairment; monitor closely. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter; reduce dose or discontinue if hyperkalemia occurs. Monitor volume status, renal function, serum electrolytes, uric acid, and blood glucose periodically. Hepatic impairment. Elderly. Pregnancy: avoid. Nursing mothers.
Carospir Pharmacokinetics
Absorption
Peak plasma concentration is reached 0.5–1.5 hours after dosing.
High fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone by ~90%.
Distribution
Plasma protein bound: >90%.
Elimination
Renal (primarily), bile. Half-life: ~1–2 hours.
Carospir Interactions
Interactions
See Contraindications. Avoid K+-sparing diuretics, K+-supplements, K+-containing salt substitutes. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH, trimethoprim. Monitor for lithium toxicity. May be antagonized by NSAIDs, acetylsalicylic acid; monitor closely. Worsening renal function with concomitant nephrotoxic drugs (eg, aminoglycosides, cisplatin, NSAIDs). Potentiates digoxin; reduce digoxin dose by ~15–30%; monitor. May potentiate CYP2C8/CYP3A substrates (eg, repaglinide, midazolam, sirolimus, tacrolimus); may need to adjust dose of substrates. Caution with cholestyramine.
Carospir Adverse Reactions
Adverse Reactions
Gynecomastia, hyperkalemia, hypotension, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, hypovolemia, hyperglycemia, gastritis, diarrhea, cramping, nausea, vomiting, ataxia, drowsiness, headache, rash; neurologic impairment, coma.
Carospir Clinical Trials
See Literature
Carospir Note
Not Applicable
Carospir Patient Counseling
See Literature
Carospir Generic Name & Formulations
Legal Class
Rx
General Description
Spironolactone 25mg/5mL; oral susp; banana flavor.
Pharmacological Class
Diuretic (K+ sparing).
How Supplied
Susp—118mL, 473mL
Manufacturer
Generic Availability
NO
Mechanism of Action
Spironolactone and its active metabolites act primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
Carospir Indications
Indications
Adjunct in hypertension.
Carospir Dosage and Administration
Adult
Not therapeutically equivalent to Aldactone. Initially 20–75mg (4–15mL) daily in single or divided doses. Titrate at 2 week intervals. If dose >100mg required, use another formulation.
Children
Not established.
Carospir Contraindications
Contraindications
Hyperkalemia. Addison's disease. Concomitant eplerenone.
Carospir Boxed Warnings
Not Applicable
Carospir Warnings/Precautions
Warnings/Precautions
Increased hyperkalemia risk with renal impairment; monitor closely. Monitor serum potassium within 1 week of initiation or titration and periodically thereafter; reduce dose or discontinue if hyperkalemia occurs. Monitor volume status, renal function, serum electrolytes, uric acid, and blood glucose periodically. Hepatic impairment. Elderly. Pregnancy: avoid. Nursing mothers.
Carospir Pharmacokinetics
Absorption
Peak plasma concentration is reached 0.5–1.5 hours after dosing.
High fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone by ~90%.
Distribution
Plasma protein bound: >90%.
Elimination
Renal (primarily), bile. Half-life: ~1–2 hours.
Carospir Interactions
Interactions
See Contraindications. Avoid K+-sparing diuretics, K+-supplements, K+-containing salt substitutes. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH, trimethoprim. Monitor for lithium toxicity. May be antagonized by NSAIDs, acetylsalicylic acid; monitor closely. Worsening renal function with concomitant nephrotoxic drugs (eg, aminoglycosides, cisplatin, NSAIDs). Potentiates digoxin; reduce digoxin dose by ~15–30%; monitor. May potentiate CYP2C8/CYP3A substrates (eg, repaglinide, midazolam, sirolimus, tacrolimus); may need to adjust dose of substrates. Caution with cholestyramine.
Carospir Adverse Reactions
Adverse Reactions
Gynecomastia, hyperkalemia, hypotension, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, hypovolemia, hyperglycemia, gastritis, diarrhea, cramping, nausea, vomiting, ataxia, drowsiness, headache, rash; neurologic impairment, coma.
Carospir Clinical Trials
See Literature
Carospir Note
Not Applicable
Carospir Patient Counseling
See Literature
