Intravenous administration of tramadol

Abstract

A method of treating pain, e.g., acute post-operative pain, by administering to a human patient(s) a therapeutically effective dose of tramadol intravenously in a dosing regimen which includes one or more loading doses administered at shortened intervals as compared to dosing at steady-state is disclosed. In preferred embodiments, the intravenous dosing regimen provides a Cmax and AUC of tramadol is similar to the Cmax and AUC of an oral dose of 100 mg tramadol HCl given every 6 hours.

1 - 15 . (canceled) 
     
     
         16 . A method of administering tramadol for treating acute pain in a human patient via an intravenous dosing regimen, comprising
 intravenously administering a first dose of tramadol to a human patient experiencing acute pain in an amount of about 50 mg;   and thereafter intravenously administering additional doses of tramadol to the human patient(s) in an amount of about 50 mg tramadol at dosage intervals of about 4 hours, except that a second dose is intravenously administered as a loading dose at a shortened interval as compared to the dosage interval of about 4 hours, and   administering another analgesic selected from the group consisting of an NSAID, acetaminophen, and another opioid analgesic before, concurrently with, or after administration of the tramadol, such that the human patient is treated for acute pain and wherein the tramadol is tramadol base or a pharmaceutically acceptable salt of tramadol.   
     
     
         17 . The method of claim  1 , wherein a total of 7 doses of 50 mg tramadol are intravenously administered on the first day of treatment and the intravenous tramadol is administered on subsequent days of treatment on a basis of a total of 6 doses of 50 mg tramadol per day until the intravenous tramadol administration is terminated. 
     
     
         18 . The method of  claim 16 , further comprising continuing to administer additional doses of tramadol to the human patient in an amount of about 50 mg tramadol at dosage intervals of about 4 hours for at least about 44 hours after the first administered dose of tramadol. 
     
     
         19 . The method of  claim 16 , wherein the second dose is administered at from about 2 to about 3 hours after the first dose. 
     
     
         20 . The method of  claim 16 , wherein the another analgesic is acetaminophen. 
     
     
         21 . The method of  claim 16 , wherein the another analgesic is an NSAID. 
     
     
         22 . The method of  claim 16 , wherein the another analgesic is another opioid analgesic. 
     
     
         23 . A method of administering tramadol for treating acute postoperative pain in a human patient via an intravenous dosing regimen, consisting of
 intravenously administering a first dose of tramadol to a human patient experiencing acute postoperative pain in an amount of about 50 mg;   thereafter intravenously administering additional doses of tramadol to the human patient in an amount of about 50 mg tramadol at dosage intervals of about 4 hours, except that a second dose is intravenously administered as a loading dose at a shortened interval as compared to the dosage interval of about 4 hours, and   administering another analgesic selected from the group consisting of an NSAID, acetaminophen, and another opioid analgesic before, concurrently with, or after administration of the tramadol, such that the human patient is treated for acute pain and wherein the tramadol is tramadol base or a pharmaceutically acceptable salt of tramadol.   
     
     
         24 . The method of  claim 23 , further comprising continuing to administer additional doses of tramadol to the human patient in an amount of about 50 mg tramadol at dosage intervals of about 4 hours for at least about 44 hours after the first administered dose of tramadol. 
     
     
         25 . The method of  claim 23 , wherein the another analgesic is acetaminophen. 
     
     
         26 . The method of  claim 23 , wherein the another analgesic is an NSAID. 
     
     
         27 . The method of  claim 23 , wherein the another analgesic is another opioid analgesic. 
     
     
         28 . The method of  claim 23 , further comprising administering the first dose of intravenous tramadol to the patient intraoperatively at wound closure. 
     
     
         29 . The method of  claim 23 , further comprising administering the first dose of intravenous tramadol to the patient on first demand of analgesia postoperatively. 
     
     
         30 . The method of  claim 23 , wherein the second dose is administered at from about 2 to about 3 hours after the first dose.