98.3F

Paracetamol IV-1.0g

Antipyretic/Analgesic & Surgical procedures

Paracetamol has been one of the most recognizable drugs, both on- and off-prescription, and it is likely to remain so in the future. As global aging, painful and disabling conditions are increasing, paracetamol has a favorable safety profile that will be of utmost importance across all ages and especially in the elderly. Several reports support the equivalent safety and efficacy profile of both oral and intravenous administrations. This conclusion is particularly relevant, suggesting that paracetamol may be used equally through both administration routes in several clinical cases in the emergency setting in chronic pain conditions.

Therapeutic indications

Paracetamol 10 mg/ml solution for infusion is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever. When administered by the intravenous route is clinically justified by an urgent need to treat pain or hyperthermia or when other routes of administration are not possible. The 100 ml vial is only for adults, adolescents, and children weighing more than 33 kg.

Dosage based on patient weight
Patient weight Dose per administration Volume per administration Maximum volume of paracetamol, solution for infusion (10 mg/ml) per administration based on upper weight limits of the group (ml)** Maximum Daily Dose ***
≤ 10 kg * 7.5 mg/kg 0.75 ml/kg 7.5ml 30 mg/kg
> 10 kg to ≤ 33kg 15 mg/kg 1.5ml/kg 49.5ml 60mg/kg not exceeding 2g
> 33 kg to ≤ 50kg 15 mg/kg 1.5ml/kg 75 ml 60mg/kg not exceeding 3g
>50kg (with additional risk factors for hepatotoxicity) 1g 100ml 100ml 3g
> 50 kg and no additional risk factors for hepatotoxicity 1 g 100ml 100ml 4g
The minimum interval between each administration must be at least 4 hours. No more than 4 doses are to be given within 24 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

Severe renal insufficiency:

It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤30 mL/min) to increase the minimum interval between each administration to 6 hours