Tramadol is indicated for relief of moderate to severe pain both acute and chronic in nature. Tramadol was compared with prolonged action morphine in patients with chronic cancer pain. Treatment was for 1-3 month with variable doses. Excellent or good results were obtained in 89% of patients with morphine. However side effects occurred in the morphine group necessitating drug withdrawal in 6/26 patients, respiratory depression was seen with morphine but not with tramadol. In another study, tramadol and pethidine were equally in controlling post-operative pain. It is well known that not all types of pain respond well to opioid analgesics. For example, cancer pain is opioid-sensitive and long term use of opioids is justifiable. In opioid-sensitive pain respiratory depression and addiction occur rarely. Long term use of tramadol in non-cancer pain is justified if the pain are pain due to nerve compression and destruction, trigeminal post-herpetic pain and central pain.
One capsule once daily to twice daily.
In patients with renal or hepatic impairment dose reduction may be necessary. Or as prescribed by the physician.
Hypersensitivity. Patients under the influence of alcohol, hypnotics and other CNS acting drugs.
Patients should be cautioned against driving vehicles or operating complicated machinery. Serious and sometimes fatal reactions have occurred when opioids and MAO inhibitors are used concomitantly.
Tramadol should be used with caution in patients with reduced respiratory reverse, elevated intracranial pressure, history of seizures, and history of hypersensitivity to opioids, myasthenia gravis and renal and hepatic dysfunction.
Though there have been no reports of dependence caused by tramadol, this cannot be ruled out. The duration of treatment should be carefully assessed and tramadol should not be continued beyond its usefulness. Intravenous administration should be slow.
Tramadol is usually well tolerated. There have not been reports of dependence even after long term therapy.
Use in Pregnancy & Lactation: It is not clear whether tramadol crosses the placenta or is excreted into the breast milk. This drug should be used during pregnancy and in nursing mothers only if it is considered necessary.
It is not clear whether tramadol crosses the placenta or is excreted into the breast milk. This drug should be used during pregnancy and in nursing mothers only if it is considered necessary.
Tramadol injection was administered to 550 patients during the double blind or open label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions are felt to be probably related to tramadol injection administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these were similar for tramadol injection with codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg.
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials and for which the possibility of a causal relationship with tramadol injection exists.
Side effects observed with Tramadol are sedation, dizziness, sweating, nausea and vomiting, dry mouth, loss of appetite, constipation, and fatigue. Rarely tramadol use may be associated with palpitation and
hypotension especially postural.
May cause serious and fatal reactions with opioids and MAOIs.
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Gesitram cap 50 mg
100's (P685/box)
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