Each 1ml parenteral solution contains 50mg Tramadol hydrochloride.
Mechanism of action:
Pharmacotherapeutic Group: Opioid analgesics
Tramadol is a centrally acting analgesic which possesses opioid agonist properties. It is active as an inhibitor of noradrenalin and serotonin uptake thereby modifying the transmission of pain impulses.
Tramadol also has an antitussive action.
Pharmacokinetic properties :
The mean bioavailability after intramuscular administration was found to be 100% and has a high tissue affinity with an apparent volume of distribution. Tramadol undergoes hepatic metabolism and is essentially excreted via the kidneys.
Indications: Dominadol is indicated for treatment of moderate to severe pain
Very common: nausea, dizziness and vomiting.
Common: Headaches, drowsiness, constipation, dry mouth, sweating and fatigue.
Uncommon and rare: allergic reactions, changes in appetite, psychiatric disorders, blurred vision, flushing, effects on cardiovascular regulation, gastrointestinal irritation.
Drug and Food Interactions:
Pregnancy and lactation:
pregnancy category (C) The product should not be used during pregnancy and lactation.
Effects on ability to drive and use machines:
Patients should be warned not to drive or operate machinery.
- The product is indicated for parenteral administration either intramuscularly, by slow intravenous injection or by infusion.
- The dose of tramadol injection should be adjusted to the intensity of the pain and the sensitivity of the individual patients.
50 or 100mg 4-6 hourly (Intravenous injection must be given slowly over 2-3minutes).
In post operative pain, an initial bolus of 100mg is administered. For the 60minutes following this initial bolus, 50mg doses may be given every 10-20minutes up to a total dose of 250mg including the initial bolus.
Subsequent doses should be 50 or 100mg 4-6hourly up to a total daily dose of 600mg.
A total parenteral daily dose of over 600mg should not be exceeded expect in special circumstances.
The dosage intervals should be carefully considered according to the patients requirements.
Creatinine clearance <30ml/min the dosing should be increased to 12hourly intervals
Creatinine clearance <10ml/min tramadol is not recommended
Under 12 years: should not be used
Symptoms of tramadol overdose are typical of opioid analgesics and they may include: vomiting, miosis, sedation, seizures, respiratory depression and hypotension, with circulatory failure and coma. Respiratory failure may also occur.
Treatment requires the maintenance of the airway and cardiovascular functions.