Farmville, NC. October 30, 2017 – 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. CaroSpir was approved by the FDA on August 4, 2017 and is now available through normal retail distribution.
CaroSpir oral suspension ensures that adult patients who have difficulty swallowing, or who cannot swallow tablets, receive a stable and consistent dose of spironolactone every time. Until now, patients who have required a liquid form of spironolactone have had to rely on unapproved pharmacy compounded formulations, which typically have limited shelf life, are not quality control tested for potency and sterility/bioburden, and are typically not reimbursed by insurance companies.
With FDA approved CaroSpir, the challenges around short-term shelf life and lack of quality control of compounded spironolactone liquids are addressed. CaroSpir is available in 118mL and 473 mL bottles, both of which have 24-month dating and are manufactured and tested at CMP Pharma’s FDA inspected GMP manufacturing facility in North Carolina. CaroSpir comes in banana flavor to improve compliance. It does not have a black box warning, nor does it have any special handling or storage requirements.
“CaroSpir is intended for a subset of the patient population that needs spironolactone, but has difficulty swallowing or inability to swallow. Until today there was no FDA-approved oral suspension of spironolactone to satisfy this unmet need. The availability of CaroSpir now gives healthcare providers and appropriate patients a convenient, safe and approved liquid option,” said Gerald Sakowski, CEO of CMP Pharma, Inc.
CaroSpir oral suspension is now available. For more information, contact CMP Pharma at 252-753-7111 or visit CaroSpir.com.
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.
ADDITIONAL IMPORTANT SAFETY INFORMATION
CAROSPIR is contraindicated for patients with the following conditions:
- Addison’s disease
- Concomitant use of eplerenone
WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS
CAROSPIR may cause the following conditions. The following clinically significant adverse reactions were reported with CAROSPIR:
- Hypotension and Worsening Renal Function
- Electrolyte and Metabolic Abnormalities
- 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.
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, full Prescribing Information and Medication Guide: www.carospir.com/prescribing-information.