Active Ingredient: Tramadol
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, between 50 milligrams tramadol and 100 milligrams tramadol, once every 4 to 6 hours.
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:
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.
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.
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.
To be taken with or without food.
For:
Intravenous, between 50 milligrams tramadol and 100 milligrams tramadol, once every 4 to 6 hours.
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome.
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.
Unless otherwise prescribed, tramadol hydrochloride should be administered as follows: the usual dose is 50 or 100 mg 4-6 hourly by the intravenous route. Dosage should be adjusted according to pain severity and response.
Intravenous injections must be given slowly over 2-3 minutes.
For post-operative pain administer an initial bolus of 100 mg. 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 400mg.
A dose adjustment is not usually necessary in elderly 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 regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
Tramadol may be administered by slow intravenous injection, or diluted in solution for administration by infusion or patient controlled analgesia.
For:
Intramuscular, between 50 milligrams tramadol and 100 milligrams tramadol, once every 4 to 6 hours.
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome.
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.
Unless otherwise prescribed, tramadol should be administered as follows: the usual dose is 50 or 100 mg 4-6 hourly by the intramuscular route. Dosage should be adjusted according to pain severity and response.
A dose adjustment is not usually necessary in elderly 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 regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
For:
Rectal, 100 milligrams tramadol, once every 4 to 6 hours.
For:
In case that patient age in years is ≥ 3, oral, between 1 milligrams tramadol per kilogram of body weight and 2 milligrams tramadol per kilogram of body weight, 3 to 4 times daily. The maximum allowed total dose is 8 milligrams tramadol per kilogram of body weight daily.
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