INDIVIDUALIZATON OF TRAMADOL DOSAGE

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

• In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of       tramadol be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis 

• The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.

• In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

TRAMADOL - ADVICE TO PATIENTS

• Potential for seizures and/or serotonin syndrome with concomitant use of serotonergic drugs or drugs that substantially decrease the metabolism of tramadol.
  
• Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.
  
• Importance of women informing their clinician if they are or plan to become pregnant or plan to breastfeed.
  
• Importance of the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, and death.
  
• Importance of swallowing extended-release tablets whole; do not crush, chew, or split the tablets.
  
• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.
  
• Importance of avoiding alcohol-containing beverages or products.
  
• Importance of informing patients of other important precautionary information.
  

TRAMADOL DESCRIPTION

• Ultram (tramadol hydrochloride) is a centrally acting analgesic. 
• The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl cyclohexanol hydrochloride. 
• The molecular weight of tramadol hydrochloride is 299.8.  
• Tramadol hydrochloride is a white, bitter, crystalline and odorless powder.  
• It is readily soluble in water and ethanol and has a pKa of 9.41.  
• The water/n-octanol partition coefficient is 1.35 at pH 7.  
• Ultram tablets contain 50 mg of tramadol hydrochloride and are white in color.
• Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax.