Carospir
Generic Name: carospir
Brand Names:
Carospir
11 DESCRIPTION CAROSPIR Oral Suspension contains 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21- carboxylic acid γ-lactone acetate per 5 mL, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Overview
11 DESCRIPTION CAROSPIR Oral Suspension contains 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21- carboxylic acid γ-lactone acetate per 5 mL, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Uses
1 INDICATIONS AND USAGE CAROSPIR is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ) use as an add-on therapy for the treatment of hypertension, to lower blood pressure.
Dosage
2 DOSAGE AND ADMINISTRATION CAROSPIR is not therapeutically equivalent to Aldactone ( 2.1 ) Heart Failure: Initiate treatment at 20 mg once daily. ( 2.2 ) Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses ( 2.3 ) Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses ( 2.4 ) 2.1 General Considerations CAROSPIR is not therapeutically equivalent to Aldactone. Follow dosing instructions given here. In patients requiring a dose greater than 100 mg, use another formulation. Doses of the suspension greater than 100 mg may result in spironolactone concentrations higher than expected [see Clinical Pharmacology (12.3) ] .
Side Effects
6 ADVERSE REACTIONS 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 following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports.
Interactions
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 acidosis has been reported with concomitant use ( 7.5 ) Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone ( 7.6 ) 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of CAROSPIR with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia.
Warnings
5 WARNINGS AND PRECAUTIONS 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 potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . 4 CONTRAINDICATIONS 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
Pregnancy
8.1 Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis [see Clinical Pharmacology (12.1) ] . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING CAROSPIR (spironolactone) Oral Suspension 25 mg/5 mL is a white to off-white, opaque, banana-flavored suspension. It is available in a 118 mL bottle (NDC 46287-020-04), a 473 mL bottle (NDC 46287-020-01), and a 5 mL unit dose cup (NDC 46287-020-20) available in a 10 count carton (NDC 46287-020-50). Store at 20° to 25°C (68° to 77°F).
Frequently Asked Questions
What is Carospir used for?▼
1 INDICATIONS AND USAGE CAROSPIR is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ) use as an add-on therapy for the treatment of hypertension, to lower blood pressure.
What are the side effects of Carospir?▼
6 ADVERSE REACTIONS 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 following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports.
Can I take Carospir during pregnancy?▼
8.1 Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis [see Clinical Pharmacology (12.1) ] . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone.
What are the important warnings for Carospir?▼
5 WARNINGS AND PRECAUTIONS 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 potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . 4 CONTRAINDICATIONS 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
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Purpose Antiseptic
Adenosinum Triphosphoricum Dinatrum, Cinnamic Acid, Colibacillinum Cum Natrum Muriaticum, Streptococcus Bovis Dna, Dysentery Bacillus, Echinacea (angustifolia), Enterococcus Faecalis, Helicobacter Pylori, Helicobacter Pylori Dna, Legionella Pneumophila, Listeria Monocytogenes, Malicum Acidum, Mycoplasma Pneumoniae, Natrum Oxalaceticum, Oroticum Acidum, Petroselinum Sativum, Pneumococcinum, Proteus (mirabilis), Proteus (morgani), Proteus (vulgaris), Riboflavinum, Pseudomonas Aeruginosa,
adenosinum triphosphoricum dinatrum, cinnamic acid, colibacillinum cum natrum muriaticum, streptococcus bovis dna, dysentery bacillus, echinacea (angustifolia), enterococcus faecalis, helicobacter pylori, helicobacter pylori dna, legionella pneumophila, listeria monocytogenes, malicum acidum, mycoplasma pneumoniae, natrum oxalaceticum, oroticum acidum, petroselinum sativum, pneumococcinum, proteus (mirabilis), proteus (morgani), proteus (vulgaris), riboflavinum, pseudomonas aeruginosa,
PURPOSE: Adenosinum Triphosphoricum Dinatrum – Mucus Congestion, Cinnamic Acid – Bladder Discomfort, Colibacillinum Cum Natrum Muriaticum – Stomach Discomfort, DNA Joint Discomfort, Dysentery Bacillus - Fever, Echinacea (Angustifolia) - Headache, Enterococcus Faecalis – Mucus Congestion, Helicobacter Pylori – Stomach Discomfort, Helicobacter Pylori DNA – Stomach Discomfort, Legionella Pneumophila - Cough, Listeria Monocytogenes – Occasional Diarrhea, Malicum Acidum – Joint Discomfort, Mycoplasma
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.