CaroSpir Liquid Formulation Approved
August 7, 2017 – The U.S. FDA has approved CaroSpir® (spironolactone oral suspension, 25mg/5mL), manufactured by CMP Pharma. CaroSpir is a new liquid formulation of a potassium-sparing diuretic used to treat patients who have high blood pressure, heart failure, or edema. The new formulation is expected to provide an additional treatment option for patients who are unable to swallow tablets, or have other difficulties swallowing. CaroSpir will be available in 118mL and 473mL bottles; starting dose recommendations vary depending upon the indication. Launch of the new formulation is expected during the fourth quarter of 2017.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.