Pharmaceutical compositions and methods of using the same
Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
1. A method of administering a local anesthetic prior to performing a diagnostic or surgical procedure on a renally impaired subject comprising:
soaking one or more pledgets in up to about 4 mL of a ready-to-use composition comprising
about 3.6% to about 4.4% cocaine hydrochloride, by weight,
a preservative,
an acidulant, and
optionally, at least one coloring additive;
contacting each pledget on a nasal mucous membrane of the subject up to about 20 minutes; and
removing each pledget from contact with a mucous membrane.
2. The method of claim 1 , wherein, the renally impaired subject has an estimated glomerular filtration rate (eGFR) in the range of about 15 mL/min./1.73 m 2 to less than 60 mL/min./1.73 m 2 .
3. The method of claim 1 , wherein, the renally impaired subject has an estimated glomerular filtration rate (eGFR) in the range of about 15 mL/min./1.73 m 2 to less than about 29 mL/min./1.73 m 2 .
4. The method of claim 1 , wherein the procedure comprises nasal endoscopy.
5. The method of claim 1 , wherein the procedure comprises nasal laryngoscopy.
6. The method of claim 1 , wherein the procedure comprises nasal debridement.
7. The method of claim 1 , wherein the procedure comprises nasopharyngeal laryngoscopy.
8. The method of claim 1 , wherein the procedure comprises laryngoscopy.
9. The method of claim 1 , wherein the method achieves an absorptivity factor for cocaine in the subject in the range of 0.640 h −1 to 0.687 h −1 .
10. The method of claim 1 , wherein the method achieves an absorptivity factor for cocaine in the subject in the range of 0.483 h −1 to 0.789 h −1 .