Indications
Paracetamol 10 mg/mL solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered necessary.
Dosage & Administration
Intravenous route:
Reset solution for infusion should not be mixed with other medicinal products.
Adult >50 kg: 1g/100ml, up to 4 times a day.
Adult 33 to 50 kg: 15 mg/kg body wt, up to 4 times a day
Neonates, Infants and Children: up to 33 kg: 15 mg/kg body wt, up to 4 times a day.
Neonates, Infants and Children: Less than 10 kg: 7.5 mg/kg body wt, up to 4 times a day.
The minimum interval between each administration must be 4 hours in patients without hepatic or renal impairment. In patients with renal and/or hepatic impairment the minimum interval between doses must not be less than 6 hours. For adults weighing from 33 to 50 kg, the maximum daily dose from all sources of paracetamol must not exceed 60mg/kg. In patients with chronic or active hepatic disease, especially those with hepatocelluar insufficiency, chronic alcoholism, chronic malnutrition and dehydration the dose should not exceed 3 g/day.
Method of administration
The paracetamol solution is administered as a 15-minutes intravenous infusion. Paracetamol solution for infusion can be diluted in a 0.9% Sodium Chloride or 5% Glucose solution up to one tenth. In this case, use the diluted solution within the hour following its preparation (infusion time included).
Side Effects
Injection site pain and burning sensation, nausea, vomiting, constipation. Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Isolated reports of thrombocytopenia have been observed.
Precautions
Paracetamol infusion should be used with caution in cases of:
• Hepatocelluar insufficiency
• Severe renal insufficiency (creatinine clearance <30 mL/min)
• Glucose-6-Phosphate Dehyrogenase (G6PD) deficiency
• Chronic alcoholism
• Anorexia, cachexia, chronic malnutrition
• Dehydration, hypovolemia
The total dose of paracetamol should not exceed 4 gm per day.
Do not use if the bottle leaks. Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. The product should be used immediately after opening and any unused solution should be discarded.
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Contraindications
Paracetamol solution for infusion is contraindicated:
In cases of hypersensitivity to paracetamol or to any of the excipients
In cases of severe hepatocellular insufficiency
In patients with hepatic failure or active liver disease.
Use in Pregnancy & Lactation
Paracetamol is not contraindicated during pregnancy and in breast-feeding women.
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