Active Ingredient: Tramadol
Management (treatment and prevention) of moderate to severe pain.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
50 - 400 mg
From 12.5 To 100 mg 4 time(s) per day every day
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances.
Unless otherwise prescribed tramadol should be administered as follows:
Adults and adolescents aged 12 years and over:
Acute pain: An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 mg or 100 mg at 4-6 hourly intervals, and duration of therapy should be matched to clinical need.
Pain associated with chronic conditions: Use an initial dose of 50 mg and then titrate dose according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported, although rarely.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
Intravenous
50 - 400 mg
From 12.5 To 100 mg 4 time(s) per day every day
Tramadol solution for injection should not be administered for longer than absolutely necessary. If long-term pain treatment with tramadol solution for injection is necessary in view of the nature and severity of the illness, then careful regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.
The tramadol solution is for parenteral injection either intramuscularly, by slow intravenous injection or diluted in solution for administration by infusion or patient controlled analgesia.
The usual dose is 50 mg or 100 mg 4 to 6 hourly by either intramuscular or intravenous routes. Intravenous injections must be given slowly over 2–3 minutes. The dose should be adjusted according to the severity of the pain and the response.
For post-operative pain, an initial bolus of 100 mg is administered. During the 60 minutes following the initial bolus, further doses of 50 mg may be given every 10-20 minutes, up to a total dose of 250 mg including the initial bolus. Subsequent doses should be 50 mg or 100 mg 4-6 hourly up to a total daily dose of 400 mg.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
Intramuscular
50 - 400 mg
From 12.5 To 100 mg 4 time(s) per day every day
Tramadol solution for injection should not be administered for longer than absolutely necessary. If long-term pain treatment with tramadol solution for injection is necessary in view of the nature and severity of the illness, then careful regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances.
The tramadol solution is for parenteral injection either intramuscularly, by slow intravenous injection or diluted in solution for administration by infusion or patient controlled analgesia.
The usual dose is 50 mg or 100 mg 4 to 6 hourly by either intramuscular or intravenous routes. Intravenous injections must be given slowly over 2–3 minutes. The dose should be adjusted according to the severity of the pain and the response.
For post-operative pain, an initial bolus of 100 mg is administered. During the 60 minutes following the initial bolus, further doses of 50 mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50 mg or 100 mg 4-6 hourly up to a total daily dose of 400 mg.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
Rectal
100 - 400 mg
From 25 To 100 mg 4 time(s) per day every day
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