Intravenous administration of tramadol

Abstract

A method of treating pain, e.g., acute post-operative pain, by intravenously administering to a human patient(s) a dose of tramadol of about 45 mg to about 80 mg, based on tramadol hydrochloride, together with an intravenous dose of acetaminophen in an amount from about 500 mg to about 1000 mg, about every 6 hours.

What is claimed is: 
     
         1 . A method of administering tramadol for treating pain via an intravenous dosing regimen, comprising intravenously administering a first dose of tramadol to a human patient in an amount from about 45 mg to about 80 mg; and concurrently administering an intravenous dose of acetaminophen in an amount from about 500 mg to about 1000 mg; and thereafter intravenously administering the doses of tramadol and acetaminophen about every 6 hours until the patient no longer requires treatment with intravenous tramadol, wherein the tramadol is tramadol base or a pharmaceutically acceptable salt of tramadol. 
     
     
         2 . The method of  claim 1 , wherein the intravenous dosing regimen provides a Cmax of tramadol which is similar to the Cmax of an oral dose of 100 mg tramadol HCl given every 6 hours at steady-state. 
     
     
         3 . The method of  claim 1 , wherein each dose of tramadol is about 60 mg tramadol hydrochloride, and each dose of acetaminophen is from about 650 mg to about 750 mg. 
     
     
         4 . The method of  claim 1 , wherein each dose of tramadol is about 60 mg. 
     
     
         5 . The method of  claim 4 , the intravenous dosing regimen of the invention provide a Cmax of tramadol at steady-state that is from about 80% to about 125% of the Cmax provided at steady-state by a 100 mg oral dose of tramadol HCl given every 6 hours. 
     
     
         6 . The method of  claim 4 , wherein the intravenous dosing regimen provides a Cmax of tramadol at steady-state from about 80% to about 125% of about 736 ng/mL. 
     
     
         7 . The method of  claim 1 , further comprising continuing to administer additional doses of tramadol and acetaminophen to the human patient for at least about 42 hours after the first administered dose of tramadol. 
     
     
         8 . The method of  claim 1 , further comprising diluting the dose of tramadol and acetaminophen in from about 50 ml to about 500 ml of a pharmaceutically acceptable fluid for injection, and standardizing the administration of the injection of the dose of tramadol and acetaminophen via the use of a pump. 
     
     
         9 . The method of  claim 8 , wherein the dose is provided in the form of a sterile solution at a concentration of about 60 mg tramadol hydrochloride and from about 650 mg to about 750 acetaminophen contained in one or more ampoules. 
     
     
         10 . The method of  claim 9 , wherein the ampoules contain the dose of tramadol together acetaminophen with a buffering agent in water for injection. 
     
     
         11 . The method of  claim 1 , further comprising diluting the dose of tramadol and acetaminophen into an IV bag for administration to the human patient. 
     
     
         12 . The method of  claim 1  wherein the patient is undergoing surgery, further comprising administering a first dose of tramadol/acetaminophen to the patient intra-operatively at wound closure, or from first demand of analgesia postoperatively, and administering further doses of intravenous tramadol/acetaminophen for at least two days post-surgery. 
     
     
         13 . The method of  claim 1 , wherein the human patient is suffering from acute post-operative pain. 
     
     
         14 . The method of claim13, further comprising switching the human patient after at least three intravenous doses of tramadol/acetaminophen, to oral doses of the same amount of tramadol and acetaminophen previously administered intravenously, such that the Cmax of tramadol at the time the human patient is switched to oral doses is similar to the Cmax provided at steady-state by a dosing regimen of 100 mg tramadol HCl administered orally every 6 hours. 
     
     
         15 . The method of  claim 1 , further comprising administering an opioid analgesic which is not tramadol to the human patient to treat breakthrough pain. 
     
     
         16 . A method of administering tramadol for treating pain via an intravenous dosing regimen, comprising intravenously administering a first dose of tramadol to a human patient in an amount of about 60 mg; and concurrently administering an intravenous dose of acetaminophen in an amount of about 650 mg; and thereafter intravenously administering the doses of tramadol and acetaminophen about every 6 hours until the patient no longer requires treatment with intravenous tramadol, wherein the tramadol is tramadol base or a pharmaceutically acceptable salt of tramadol, such that the intravenous dosing regimen provides a Cmax of tramadol which is similar to the Cmax of an oral dose of 100 mg tramadol HCl given every 6 hours at steady-state. 
     
     
         17 . The method of  claim 16 , the intravenous dosing regimen of the invention provide a Cmax of tramadol at steady-state that is from about 80% to about 125% of the Cmax provided at steady-state by a 100 mg oral dose of tramadol HCl given every 6 hours. 
     
     
         18 . The method of  claim 17 , wherein the intravenous dosing regimen provides a Cmax of tramadol at steady-state from about 80% to about 125% of about 736 ng/mL. 
     
     
         19 . A kit, comprising a vial containing an intravenous dose of tramadol or a pharmaceutically acceptable salt thereof in an amount from about 45 mg to about 80 mg (based on the hydrochloride salt); and a vial containing an intravenous dose of acetaminophen in an amount from about 500 mg to about 1000 mg. 
     
     
         20 . The kit of  claim 19 , which contains additional doses of tramadol and acetaminophen.