Grünenthal GmbH

TV Pharmaceutical and Investment Promotion Company Limited

Paracetamol; Tramadol hydrochloride

325 mg; 37.5 mg

36 months

Film-coated tablet

Box of 3 blisters x 10 tablets; Box of 6 blisters x 10 tablets

400110772724

12/08/2024

12/08/2029

Analgesics; opioids in combination with non-opioid analgesics

Tracedol is indicated for the symptomatic treatment of moderate to severe pain.
The use of Tracedol should be restricted to patients with moderate to severe pain requiring a combination of paracetamol and tramadol (see Pharmacodynamic properties).

The use of Tracedol should be restricted to patients whose moderate to severe pain requires a combination of paracetamol and tramadol.
The dose should be individually adjusted according to the intensity of the pain and the sensitivity of the patient. The lowest effective analgesic dose should generally be selected. The total dose must not exceed 8 tablets per day (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol). The dosing interval should not be less than 6 hours.
Adults and adolescents (12 years of age and older):
+ The recommended starting dose is 2 tablets of Tracedol. Additional doses can be taken as needed, up to a maximum of 8 tablets per day.
+ The dosing interval must not be less than 6 hours.
Duration of treatment:
+ Under no circumstances should Tracedol be administered for longer than absolutely necessary. If repeated use or long-term treatment is required due to the nature and severity of the illness, careful, regular monitoring should be conducted to assess whether continued treatment is necessary.
Special Populations:
- Paediatric population: The safety and efficacy of Tracedol in children under 12 years of age have not been established. Therefore, treatment is not recommended in this population.
- Elderly patients: A dose adjustment is not usually necessary in patients up to 75 years old with no clinically manifest hepatic or renal impairment. In patients over 75 years of age, elimination may be prolonged. Therefore, the dosage intervals may be extended according to the patient's requirements.
- Renal impairment/dialysis: The elimination of tramadol is delayed. In these patients, prolongation of the dosage intervals should be carefully considered according to the patient's clinical response.
- Hepatic impairment: The elimination of tramadol is delayed in patients with hepatic impairment. In these patients, extension of the dosing intervals should be carefully considered according to individual response. Due to the presence of paracetamol, Tracedol must not be used in patients with severe hepatic impairment.
In adults, the following dosage recommendations may serve as a general guide for endotracheal intubation and muscle relaxation for short- to long-lasting surgical procedures, as well as for use in the intensive care unit.
Surgical Procedures:
- Tracheal intubation: The standard intubation dose of rocuronium bromide for routine anesthesia is 0.6 mg/kg, which provides adequate intubation conditions within 60 seconds in nearly all patients. A dose of 1.0 mg/kg rocuronium bromide is recommended to facilitate endotracheal intubation during rapid sequence induction of anesthesia, which also provides adequate intubation conditions within 60 seconds in nearly all patients. If a dose of 0.6 mg/kg rocuronium bromide is used for rapid sequence induction, intubation of the patient should be performed 90 seconds after administration.
- Cesarean section: A dose of 0.6 mg/kg rocuronium bromide does not affect the Apgar score, fetal muscle tone, or cardiorespiratory adaptation. Umbilical cord blood sampling indicates only limited placental transfer of rocuronium bromide, with no clinically observable adverse effects in the newborn. The 1.0 mg/kg dose has been investigated during rapid sequence induction, but not specifically in patients undergoing Cesarean section.
- Higher doses: Should there be a reason for selection of higher doses, initial doses of up to 2 mg/kg rocuronium bromide have been administered without adverse cardiovascular effects. Using higher doses decreases the onset time and increases the duration of action.
- Maintenance Dosing: The recommended maintenance dose of rocuronium bromide is 0.15 mg/kg; during long-term inhalational anesthesia, it should be reduced to 0.075–0.1 mg/kg. The maintenance dose should ideally be administered when the twitch height recovers to 25% of baseline control twitch height, or when 2 to 3 responses to train-of-four (TOF) stimulation are present.
- Continuous Infusion: If rocuronium bromide is administered by continuous infusion, an initial loading dose of 0.6 mg/kg is recommended. Once neuromuscular blockade begins to recover, continuous infusion should be initiated. The infusion rate should be titrated to maintain twitch response at 10% of baseline control twitch height or to maintain 1 to 2 responses to train-of-four (TOF) stimulation. In adult patients under intravenous anesthesia, this corresponds to an infusion rate of 0.3–0.6 mg/kg/h, and under inhalational anesthesia, the rate ranges from 0.3–0.4 mg/kg/h. Continuous neuromuscular monitoring is recommended, as dosage requirements vary with individual patients and anesthetic methods used.
- Pediatric Patients: For neonates (0–27 days), infants (28 days–2 months), young children (3–23 months), children (2–11 years), and adolescents (12–17 years), the recommended intubation dose during routine anesthesia and the maintenance dose are similar to those in adults. However, the duration of action of a single intubating dose is longer in neonates and infants compared to children. For continuous infusion in pediatrics, infusion rates—with the exception of children aged 2 to 11 years—are comparable to adult rates. Children aged 2 to 11 years may require higher infusion rates. Thus, an initial infusion rate similar to that in adults is recommended for children (2–11 years), which should subsequently be adjusted to maintain twitch tension at 10% of baseline twitch height, or 1 to 2 responses to train-of-four stimulation throughout the procedure. Clinical experience with rocuronium bromide during rapid sequence induction (RSI) in pediatric patients is limited; therefore, it is not recommended to facilitate tracheal intubation during rapid sequence induction in this population.
- Geriatric Patients and Patients with Hepatic, Biliary Disorders, and/or Renal Impairment: The standard intubation dose of rocuronium bromide for elderly patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anesthesia is 0.6 mg/kg. A dose of 0.6 mg/kg should be considered for rapid sequence induction in patients anticipated to have a prolonged duration of action. Regardless of the anesthetic technique employed, the recommended maintenance dose for these patients is 0.075–0.1 mg/kg, and the recommended infusion rate is 0.3–0.4 mg/kg/h.
- Overweight and Obese Patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight), doses should be reduced and calculated on the basis of ideal body weight (IBW).
Use in Intensive Care Units:
- Tracheal Intubation:
For tracheal intubation, the dosage recommendations are the same as described for surgical procedures.
- Maintenance Dosing:
An initial loading dose of rocuronium bromide 0.6 mg/kg is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train-of-four (TOF) stimulation. The dosage should always be titrated to individual patient response. In adult patients, the recommended initial infusion rate to maintain neuromuscular block at 80% to 90% (1 to 2 twitches to TOF stimulation) is 0.3–0.6 mg/kg/h during the first hour of administration. The infusion rate should be decreased over the following 6–12 hours, according to the individual response. Thereafter, dose requirements remain relatively constant. High inter-patient variability in hourly infusion rates has been observed in clinical studies. The mean infusion rate ranges from 0.2–0.5 mg/kg/h depending on the nature and extent of organ failure, concomitant medication, and individual patient status. To ensure optimal individualized control, continuous neuromuscular transmission monitoring is strongly recommended. Administration of rocuronium bromide for up to 7 days has been investigated.
- Special Populations:
Rocuronium bromide is not recommended to facilitate mechanical ventilation in pediatric and geriatric patients due to the lack of safety and efficacy data.