Tuzistra Approved for Cough and Cold
May 1, 2015 – The U.S. Food and Drug Administration (FDA) approved Tuzistra XR (codeine polistirex and chlorpheniramine polistirex), manufactured by Vernalis. Tuzistra XR is an extended-release, cherry-flavored oral suspension indicated for treating adults with coughs and other symptoms of colds or upper respiratory allergies. Recommended dosing of Tuzistra XR is 10mL once every 12 hours with a limit of 20mL in any 24-hour period. Tuzistra XR is a C-III controlled substance and it is not approved for use by patients under the age of 18 years. It carries a boxed warning, cautioning that respiratory depression and death have occurred after administering codeine to children who were ultra-rapid metabolizers of the drug. Vernalis plans to launch Tuzistra XR before the next cold season begins in late fall.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.