- 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.
- 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.
- risk of seizures
- risk of abuse, dependence and tolerance
- relatively high incidence of nausea and vomiting
- withdrawal symptoms following abrupt discontinuation
- short half-life necessitates dosing of immediate-release formulation every 4 to 6 hours
