CMP Pharma, Inc. Announces Unit Dose Packaging for CaroSpir^®, The First and Only FDA-Approved Spironolactone Oral Suspension

Farmville, NC. Oct., 18, 2021 /PRNewswire/ –CMP Pharma today announced that CaroSpir (Spironolactone Oral Suspension, 25 mg/5 mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone, is now available in a unit dose cup.

CaroSpir ensures that adult patients who have difficulty swallowing or who cannot swallow tablets receive a stable and consistent dose of spironolactone every time without the concerns associated with unapproved compounded formulations. The new unit dose package makes administering CaroSpir even easier and more convenient for health care providers.

The 5 mL cups contain a single pre-measured dose of CaroSpir, helping health care providers save time, minimize product waste, reduce risk associated with handling of medications that should not be crushed and reduce the burden of administration. The single dose package allows for a more efficient use of nursing resources by eliminating the time needed for compounding or pouring at the bedside.

“CaroSpir is a convenient, safe, and approved liquid option for patients who need it, and the new unit dose cup makes administering CaroSpir even easier for busy healthcare workers,” said Gerald Sakowski, CEO of CMP Pharma, Inc.

Unit dose CaroSpir is available in cartons of 10 cups, 5mL per cup. CaroSpir is also available in 118 mL and 473 mL bottles. All formulations have 24-month dating and are manufactured and tested at CMP Pharma’s FDA-inspected GMP manufacturing facility in Farmville, North Carolina.

The new CaroSpir unit dose is now available through normal retail distribution. For more information, contact CMP Pharma at 252-753-7111 or visit CaroSpir.com.

About CaroSpir

CaroSpir (spironolactone oral suspension) is indicated for 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, and is usually administered in conjunction with other therapies. CaroSpir is also indicated for use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents, as part of comprehensive cardiovascular risk management. Lastly, CaroSpir is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.

CaroSpir is contraindicated for patients with the following conditions: hyperkalemia, Addison’s disease, and concomitant use of eplerenone.

About CMP Pharma, Inc.

CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including liquids and semi-solids.  CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.

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.

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.

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.

Please click link for full Important Safety Information and full Prescribing Information: https://www.carospir.com/prescribing-information/

CAR-00226