Tramadol hydrochloride has been given in single oral doses of 50, 75, 100, 150 and 200 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars).
In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg.
This medicine duration of action is longer than that of naloxone (1 to 2 hours), therefore repeated doses may be necessary to maintain respiration. In one case report of an HIV positive man who overdosed on a calculated tramadol dose of 5.5 grams, a naloxone infusion lasting 16 hours was required for symptoms of cerebral and respiratory depression in the patient. The package insert states that convulsions have occurred in mice receiving naloxone following toxic doses and warns that it should be used cautiously. Seizures have been suppressed with benzodiazepines or barbiturates. Attempting to increase drug removal by forced diuresis, hemodialysis, or hemoperfusion is not recommended.
A dose of 100 mg tramadol hydrochloride tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. In single-dose models of pain following surgical procedures, 150 mg provided analgesia generally comparable to the combination of acetaminophen 650 mg with propoxyphene napsylate 100 mg, with a tendency toward later peak effect.
It has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving this medicine.
Tramadol hydrochloride conclusions
It appears to be an effective analgesic for moderate, but not severe pain, especially in patients who experience significant adverse reactions to conventional analgesics. Short term use has been associated with the fewest side-effects. Due to its unique mechanism of action and associated toxicities a careful patient history, including current medications, should be conducted before therapy is initiated to avoid adverse effects.
Dependence and drug abuse
Tramadol hydrochloride has a potential to cause psychic and physical dependence of the morphine-type (m-opioid). The drug has been associated with craving, drug-seeking behavior and tolerance development. Cases of abuse and dependence have been reported. Tramadol should not be used in opioid-dependent patients. It can reinitiate physical dependence in patients that have been previously dependent or chronically using other opioids. In patients with a
tendency to drug abuse, a history of drug dependence, or are chronically using opioids, treatment with tramadol is not recommended.
