CaroSpir provides a stable and consistent treatment option for adult patients who have difficulty swallowing and are suffering from heart failure, edema caused by heart failure and cirrhosis, and hypertension. In clinical studies, spironolactone has demonstrated significant mortality benefits and reduced the risk of hospitalization for cardiac causes.
CaroSpir does not carry a black box warning.
CaroSpir oral suspension is now available. For more information, contact CMP Pharma at 252-753-7111.
CaroSpir is not therapeutically equivalent to Aldactone tablets. For an equivalent dose, CaroSpir results in 15 to 37% higher serum concentration compared to Aldactone tablets.
A high fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone (as measured by AUC) by approximately 90%. Patients should establish a routine pattern for taking CAROSPIR with regard to meals.
See Prescribing Information for important dosage information.
Spironolactone is on the NIOSH List of Hazardous Drugs in Healthcare Settings, and is subject to legally enforceable regulatory guidelines such as USP-797 and the upcoming USP-800.
These protocols include double chemotherapy gloves, protective gowns, ventilated engineering control, and—if not compounded in a control device—eye/face and respiratory protection.³ But there’s an alternative: CaroSpir, an FDA-approved oral suspension of spironolactone. Unlike all other spironolactone dosage forms on the market, CaroSpir does not have a black box warning. There are no special handling and storage requirements with CaroSpir.
USP <800> guidelines for handling a NIOSH listed drug such as spironolactone tablets being crushed or compounded do not apply to CaroSpir. The USP <800> guidelines for administering any liquid form of a NIOSH drug would apply, based on the facility’s Assessment of Risk (AoR) of the drug.
The pharmacy board of several states have conducted inspections to ensure compliance with USP-797 standards in hospitals. It is expected that USP-800 will result in pharmacy inspections by both state boards and the FDA.
3 NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138).
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We want every patient who needs CaroSpir to have access to it. That’s why we’ve created the EasyPay Program so patients can lower the out-of-pocket costs associated with a CaroSpir prescription.
Patients can save up to $75 on each prescription using their EasyPay Card.
CAROSPIR is an antagonist of aldosterone indicated for:
CAROSPIR is contraindicated for patients with the following conditions:
CAROSPIR may cause the following conditions.
The most common adverse reaction (incidence > 5%) with CAROSPIR treatment is the increased occurrence of gynecomastia in men.
Talk to your healthcare provider about other possible side effects with CAROSPIR. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, INC. at 1-844-321-1443 , or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
CAROSPIR oral suspension, 25 mg/5 mL, is not therapeutically equivalent to tablet forms of spironolactone. Follow dosing instructions for CAROSPIR. In patients requiring a dose greater than 100 mg, use another formulation of spironolactone. Doses of CAROSPIR suspension greater than 100 mg may result in spironolactone concentrations higher than expected.
Please see Prescribing Information for additional safety information.
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; use as an add-on therapy for the treatment of hypertension, to lower blood pressure; the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions.
CAROSPIR is contraindicated for patients with the following conditions: hyperkalemia; Addison’s disease; concomitant use of eplerenone.
