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Ultram Tablet (Tramadol Hydrochloride + Paracetamol )

  • Tramadol Hydrochloride 37.5 mg + Paracetamol 325 mg Tablets
  • For short term (five days or less) management of moderate to severe acute pain in adults
  • Tramadol is a centrally acting synthetic opioid analgesic. It inhibits reuptake of norepinephrine and serotonin. Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties. It weakly inhibits prostaglandin synthesis in the central nervous system (specifically cyclooxygenase (COX)-2).
  • Initiate treatment with two tablets every 4 to 6 hours as needed for pain relief; maximum of 8 tablets per day.
  • Hypersensitivity to tramadol, acetaminophen, any other active ingredients of this formulation and in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. Ultram may worsen central nervous system and respiratory depression in these patients.
  • In acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. It may worsen central nervous system and respiratory depression in these patients. Use cautiously in patients with hepatotoxicity, respiratory and history of seizure. Ultram carries the potential of being misused or abused. The possibility of illegal or illicit use should be considered when prescribing or dispensing Ultram.
  • Safety and efficacy of this combination has not been studied in this population. Hence, not recommended.
  • The concomitant use of the combination of tramadol and acetaminophen with CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1 metabolite, concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
  • Asthenia, hot flush, dizziness, headache, somnolence, abdominal pain, constipation, dyspepsia, flatulence, nausea, vomiting.
  • Analgesics & Antipyretics