The First and Only FDA-approved Liquid Spironolactone customized care and consistent dosing

A stable, consistent, and ready to use liquid spironolactone for adult patients who have difficulty swallowing.

Interested in CaroSpir®? Contact CMP Pharma at 252-753-7111

Available in: 5mL unit dose cups | 118mL bottle | 473mL bottle

What is CaroSpir?

CaroSpir is the first and only FDA-approved oral suspension of spironolactone that provides a stable, ready to use, and consistent liquid treatment option for adult patients who have difficulty swallowing, or who cannot swallow tablets, and are suffering from heart failure, edema caused by heart failure and cirrhosis, and hypertension.

CaroSpir addresses the complexities and inconsistencies of crushing/compounding by providing patients with an FDA-approved oral liquid suspension of spironolactone. It eliminates the need for additional preparation by a pharmacist or patient and it does not have special storage requirements.

CaroSpir Educational Resources

Dysphagia & The Need For A Liquid Suspension of Spironolactone

Did you know?

69%

of older patients report missing doses of a tablet or capsule due to difficulties swallowing

Dysphagia is the medical term used to describe difficulty swallowing. It can include difficulty starting a swallow (oropharyngeal dysphagia), issues in the throat (pharyngeal dysphagia), and the sensation of food being stuck (esophageal dysphagia).

It’s important to optimize treatment plans for patients with dysphagia given these complications. Dysphagic patients who suffer from chronic heart failure, edema caused by heart or liver failure, and/or hypertension are often prescribed spironolactone that is crushed/
compounded from tablets into a liquid form.

Dysphagic Patients:

Unfortunately, liquids derived from crushed/compounded tablets raise concerns about patient safety and efficacy, and they have come under increasing scrutiny from the FDA.

Patients who may need an oral liquid

  • Stroke
  • Parkinson’s Disease
  • ALS
  • Multiple Sclerosis
  • Cerebral Palsy

“Crushing tablets or opening capsules should be avoided and liquid formulations should be used whenever possible”

NIOSH List of Antineoplastic an Other Hazardous Drugs In Healthcare Settings, 2016

When you crush/compound spironolactone does it behave like the tablet or like the FDA-approved liquid?

Spironolactone Time vs Mean Concentration Plot Linear Scale

Graph showing important pharmacokinetic differences with CaroSpir

An open label, randomized, two treatment, two period, two sequence, crossover, single dose, oral pharmacokinetic and comparative bioavailability study of spironolactone suspension 100 mg (20 mL of 25 mg/ 5 mL) with Aldactone® (spironolactone) tablets USP, 100 mg healthy adult subjects under the fasting condition.

CaroSpir delivers a consistent potency of spironolactone compared to compounded preparations

Dissolution Study Graph on CaroSpir

An in-vitro comparison study using a discriminating dissolution method was performed to show the comparison of 100 mg Spironolactone tablets when compounded and made into a suspension liquid according to USP and pharmacy methods and CaroSpir Oral Suspension, 25 mg/5 mL.

Disparities in dosing potency are dependent upon many variables including the consistency of the preparation and are influenced by the compounding procedure, person compounding, and compounding vehicles.

Results demonstrated that CaroSpir, the first and only FDA approved spironolactone oral suspension, delivered a consistent potency of spironolactone dose to dose, compared to compounded preparations that routinely showed potency inconsistencies.

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EasyPay Program Copay Cards

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.

Healthcare providers can help their patients save up to $75 on each prescription using the EasyPay Card.

Click the links below to print the EasyPay card:

Illustration of a Easypay Program Copay Card

Important Safety Information

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
  • use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
  • the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions

Contraindications

CAROSPIR is contraindicated for patients with the following conditions:

  • Hyperkalemia
  • Addison’s disease
  • Concomitant use of eplerenone

Warnings And Precautions/Adverse Reactions

CAROSPIR may cause the following conditions.

  • Hyperkalemia
  • Hypotension and Worsening Renal Function
  • Electrolyte and Metabolic Abnormalities
  • Gynecomastia
  • Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites

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.

Administration

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.

Drug Interactions

  • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia.
  • Lithium: Increased risk of lithium toxicity.
  • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of CAROSPIR.
  • Digoxin: CAROSPIR can interfere with radioimmunologic assays of digoxin. Spironolactone and its metabolites increase the apparent exposure to digoxin.
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use.
  • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone.

Please see Prescribing Information for additional safety information.

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Indication

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.

Important Safety Information

CAROSPIR is contraindicated for patients with the following conditions: hyperkalemia; Addison’s disease; concomitant use of eplerenone.

Read More about Carospir’s Safety Information