Pharmaceutical compositions and methods of using the same
View Patent ↗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 subject with hepatic or renal impairment comprising:
soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising:
about 3.6% to about 4.4% cocaine hydrochloride;
about 0.07% to about 0.20% sodium benzoate;
an acidulant;
optionally, at least one coloring additive; and
water,
contacting each pledget on a nasal mucous membrane of the subject for up to 20 minutes, and
removing each pledget.
2. The method of claim 1 , wherein the subject has hepatic impairment.
3. The method of claim 2 , wherein the hepatic impairment leads to increased systemic exposure of the cocaine hydrochloride.
4. The method of claim 2 , wherein the subject has a Child-Pugh Grade of Grade B.
5. The method of claim 2 , wherein the subject has a Child-Pugh Grade of Grade C.
6. The method of claim 1 , wherein the subject has renal impairment.
7. The method of claim 6 , wherein the renal impairment leads to increased systemic exposure of the cocaine hydrochloride.
8. The method of claim 6 , wherein the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 15 mL/min/1.73 m 2 to about 29 mL/min/1.73 m 2 .
9. The method of claim 1 , wherein, the procedure is a nasal endoscopy.
10. The method of claim 1 , wherein the acidulant is citric acid.
11. A method of administering a local anesthetic prior to performing a diagnostic or surgical procedure on a subject with hepatic or renal impairment comprising:
soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising:
about 3.6% to about 4.4% cocaine hydrochloride;
a preservative;
about 0.01% to about 1.0% citric acid;
optionally, at least one coloring additive; and
water,
contacting each pledget on a nasal mucous membrane of the subject for up to 20 minutes, and
removing each pledget.
12. The method of claim 11 , wherein the subject has hepatic impairment.
13. The method of claim 11 , wherein the hepatic impairment leads to increased systemic exposure of the cocaine hydrochloride.
14. The method of claim 12 , wherein the subject has a Child-Pugh Grade of Grade B.
15. The method of claim 12 , wherein the subject has a Child-Pugh Grade of Grade C.
16. The method of claim 11 , wherein the subject has renal impairment.
17. The method of claim 11 , wherein the renal impairment leads to increased systemic exposure of the cocaine hydrochloride.
18. The method of claim 16 , wherein, the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 15 mL/min/1.73 m 2 to about 29 mL/min/1.73 m 2 .
19. The method of claim 11 , wherein, the procedure is a nasal endoscopy.
20. The method of claim 11 , wherein the preservative is sodium benzoate.