Active Ingredient: Tapentadol
Tapentadol is indicated for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
200 - 700 mg
From 50 To 175 mg 4 time(s) per day every day
The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient.
Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements.
On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved. The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended.
The film-coated tablets are intended for acute pain situations. If longer term treatment is anticipated or becomes necessary and effective pain relief in the absence of intolerable adverse events was achieved with tapentadol, the possibility of switching the patient to therapy with tapentadol prolonged release tablets should be considered.
As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis.
Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol. When a patient no longer requires therapy with tapentadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Tapentadol can be taken with or without food.
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