Active Ingredient: Paracetamol
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 33 kg and patient weight is ≤ 50 kg, intravenous, 15 milligrams paracetamol per kilogram of body weight, 1 to 4 times daily. The maximum allowed total dose is 60 milligrams paracetamol per kilogram of body weight daily.
Regimen B: In case that patient weight is ≥ 50 kg, intravenous, 1,000 milligrams paracetamol, 1 to 4 times daily.
Indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.
Dosing based on patient weight (please see the dosing table here below).
| Patient weight | Dose per administration | Volume per administration | Maximum volume per administration** | Maximum Daily Dose*** |
|---|---|---|---|---|
| >33 kg to ≤50 kg | 15 mg/kg | 1.5 mL/kg | 75 mL | 60 mg/kg not exceeding 3g |
| >50 kg with additional risk factors for hepatotoxicity | 1 g | 100 mL | 100 mL | 3 g |
| >50 kg and no additional risk factors for hepatotoxicity | 1 g | 100 mL | 100 mL | 4 g |
** Patients weighing less will require smaller volumes. The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours. The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
*** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.
No dose adjustment is usually required in geriatric patients.
For:
Oral, between 0.5 grams paracetamol and 1 grams paracetamol, 4 to 6 times daily. The maximum allowed total dose is 4 grams paracetamol daily.
1 g every 4 hours to a maximum of 4 g in 24 hours.
For:
In case that patient age in months is ≥ 3, rectal, 15 milligrams paracetamol per kilogram of body weight, once every 6 hours.
For:
Regimen A: In case that patient age in months is ≥ 3, oral, between 10 milligrams paracetamol per kilogram of body weight and 15 milligrams paracetamol per kilogram of body weight, 3 to 4 times daily.
Regimen B: In case that patient age in months is ≤ 3, oral, between 5 milligrams paracetamol per kilogram of body weight and 10 milligrams paracetamol per kilogram of body weight, 3 to 4 times daily.
For:
Regimen A: In case that patient weight is ≤ 10 kg, intravenous, 7.5 milligrams paracetamol per kilogram of body weight, 1 to 4 times daily. The maximum allowed total dose is 30 milligrams paracetamol per kilogram of body weight daily.
Regimen B: In case that patient weight is ≥ 10 kg and patient weight is ≤ 33 kg, intravenous, 15 milligrams paracetamol per kilogram of body weight, 1 to 4 times daily. The maximum allowed total dose is 60 milligrams paracetamol per kilogram of body weight daily.
Indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.
Dosing based on patient weight (please see the dosing table here below).
| Patient weight | Dose per administration | Volume per administration | Maximum volume of paracetamol (10 mg/mL) per administration based on upper weight limits of group (mL)** | Maximum Daily Dose*** |
|---|---|---|---|---|
| ≤10 kg* | 7.5 mg/kg | 0.75 mL/kg | 7.5mL | 30 mg/kg |
| >10 kg to ≤33 kg | 15 mg/kg | 1.5 mL/kg | 49.5mL | 60 mg/kg not exceeding 2g |
| >33 kg to ≤50 kg | 15 mg/kg | 1.5 mL/kg | 75 mL | 60 mg/kg not exceeding 3g |
* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.
** Patients weighing less will require smaller volumes. The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours. The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.
*** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.
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