COMPOSITION :
Paramol® Infusion 1 g/100 ml, each 100 ml contains : Paracetamol 1 g.
DESCRIPTIONS :
Paramol® Infusion with Paracetamol as its active ingredient is available in 1 g/100 ml.
INDICATIONS :
Paramol® is 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.
DOSAGE AND ADMINISTRATIONS :
- Intravenous route : The 100 ml glass infusion bottle is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old).
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- Adolescents and adults weighing more than 50 kg : Paracetamol 1 g per administration, i.e. one bottle of 100 ml, up to 4 times a day. The minimum interval between each administration must be 4 hours. The maximum daily dose must not exceed 4 g.
- Children weighing more than 33 kg (approximately 11 years old), adolescents and adults weighing less than 50 kg : Paracetamol 15 mg/kg per administration, i.e. 1.5 ml solution per kg up to 4 times a day. The minimum interval between each administration must be 4 hours. The maximum daily dose must not exceed 60 mg/kg (without exceeding 3 g).
- Severe renal insufficiency : It is recommended when giving Paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/minute) to increase the minimum interval between each administration to 6 hours.
- Method of administration : The Paracetamol solution is administered as a 15 minutes intravenous infusion.
OVERDOSAGE :
There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Overdosing may be fatal in these cases.
Symptoms generally appear within the first 24 hours and comprise : Nausea, vomiting, anorexia, pallor, abdominal pain. Overdose 7.5 g or more of Paracetamol in a single administration in adult and 140 mg/kgBW in a single administration in children, causes hepatic cytolysis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephatolopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and billirubin are observed together with decreased prothrombin levels that may appear 12 – 48 hours after administration.
Clinical symptoms of liver damage are usually evident initially after 2 days and reach a maximum after 4 – 6 days.
Emergency measures :
- Immediate hospitalization.
- Before beginning treatment, take a tube of blood for plasma Paracetamol assay, as soon as possible after overdose.
- The treatment includes administration of the antidote, N-acetylcystein (NAC), by the IV or oral route, if possible before the 10 hours. NAC can, however give some degree protection even after 10 hours, but in these cases prolonged treatment is given.
- Symptomatic treatment.
- Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in 1 – 2 weeks with full return of normal liver function. In very severe cases, however, liver transplantation may be necessary.
CONTRAINDICATIONS :
- In patient with hypersensitivity to Paracetamol or to Propacetamol hydrochloride (prodrug of Paracetamol) or to any of the excipients.
- In cases of severe hepatocellular insufficiency.
WARNINGS AND PRECAUTIONS :
Warnings
- It is recommended to use a suitable analgesic oral treatment as soon as this route of administration possible.
- In order to avoid the risk of overdose, check that other medicines administered do not contain Paracetamol. Doses higher than the recommended entails the risk for very serious liver damage. Clinical signs and symptoms on liver damage are usually seen until 2 days, and up to a maximum of 4 – 6 days after administration. Treatment with antidote should be given as soon as possible (see OVERDOSAGE).
Precautions
Paracetamol should be used with caution in cases of :
- Hepatocellular insufficiency
- Severe renal insufficiency (creatinine clearance ≤ 30 ml/minute), the minimum interval between each administration should be increased to 6 hours
- Chronic alcoholism
- Chronic malnutrition (low reserves of hepatic glutathione)
- Dehydration
- Pregnancy : Paracetamol infusion should only be used during pregnancy after a careful benefit-risk assessment. In this case, the recommended posology and duration must be strictly observed.
- Lactation : After oral administration, Paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol may be used in breast-feeding woman.
PRESENTATION :
Paramol® Infusion 1 g/100 ml Box, 1 bottle @ 100 ml Reg. No. DKL1202346249A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
