INDICATIONS
For the management of moderate to severe pain.
DOSAGE AND ADMINISTRATION
Adult
The recommended dose is 1 or 2 tablets every 4 to 6 hours for 5 days or less.. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.
Children
The effective and safe use of FASTDOL has not been established in children below the age of 16 years. Treatment is therefore not recommended in this population.
OR AS DIRECTED BY THE PHYSICIAN.
SIDE EFFECTS
The most commonly reported undesirable effects during the clinical trials performed with the Paracetamol/Tramadol Hydrochloride combination were nausea, dizziness and somnolence.
CONTRAINDICATIONS
Hypersensitivity to Tramadol Hydrochloride, paracetamol or to any of the ingredient of the medicinal product. FASTDOL should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.
PRECAUTIONS
Should be used with caution in opioid dependent patients, or in patients with cranial trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness for unknown reasons, with problems affecting the respiratory center or the respiratory function, or with an increased intracranial pressure. Paracetamol in over dosage may cause hepatic toxicity in some patients.
PREGNANCY AND LACTATION
Pregnancy category C. Since it is a fixed combination of active ingredients including Tramadol Hydrochloride, it should not be used during pregnancy & lactation.
DRUG INTERACTIONS
Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors such as quinidine, fluoxetine, paroxetine. and amitriptyline (CYP2D6 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of tramadol, increasing the risk for serious adverse events including seizures and serotonin syndrome.
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