Propacetamol hydrochloride.
Each vial contains: Propacetamol HCl 1 g.
Pharmacology: Pharmacodynamics/Pharmacokinetics: Propacetamol is a bioprecursor of Paracetamol. It is rapidly hydrolyzed by plasma esterases and releases its constituent paracetamol by the end of its intravenous or intramuscular administration. Its metabolism is identical to that of paracetamol.
Propacetamol provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours.
Symptomatic relief of mild to moderate pain and fever.
Propacetamol is delivered by I.V. and I.M.: Adult and children over 15 years old: 1-2 g as needed, maximum of 4 times per day if necessary. The time between each treatment should not be less than 4 hours and the daily dosage shall not exceed 8 g.
Children between the age of 3 and 15 years: 30 mg/kg as needed, maximum 4 times per day. The time between each treatment should not be less than 4 hours and the daily dosage shall not exceed 120 mg.
There is a risk of liver damage, particularly in elderly, young children, patients with liver disease, chronic alcoholism, chronic malnutrition and in patients receiving enzyme inducers. Overdose may be fatal in these cases.
Acute toxicity symptoms generally appear within 24 hours and include: nausea, vomiting, anorexia, pallor, and abdominal pain. When administered in excessive dose, patients experience liver failure, metabolic acidosis, encephalopathy which may lead to coma and death. In particular, liver necrosis is caused by activating liver's transaminase, lactose dehydrogenase, and bilirubin.
Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12 to 48 hours after administration. Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days.
Treatment for an overdose includes the oral or intravenous administration of the antidote N-acetylcysteine (NAC), if possible before the 10 hours. However, NAC may give some degree of protection even after 10 hours, and prolonged treatment should be given in this case.
Allergy and hypersensitivity to Propacetamol, Paracetamol, Diethylglycine or similar compounds. Suspected allergy to propacetamol in any person handling propacetamol in any person handling propacetamol, especially healthcare personnel, and having presented with contact eczema. Severe liver disease. Concomitant anticoagulant treatment (risk of hematoma as with all drugs injectable by intramuscular route). As a general rule, this drug should not be used during the first trimester months of pregnancy.
Propacetamol should not be given together with other pain relievers containing Paracetamol, e.g. combined medication. Higher dosages than the recommended one can lead to the risk of most severe liver damage. Clinical signs of liver damages are usually seen after 4-6 days. Antidote should be given as soon as possible. Careful use of Propacetamol on patients with anamnesis of liver disease or heavy drinkers should be observed. Cases of contact eczema due to hypersensitivity have been reported to care personnel after treatment of Propacetamol. Among those, severe hypersensitivity reactions such as angioedema, general eczema and itching have been reported during treatment with Propacetamol. Earlier hypersensitivity against Propacetamol should be investigated prior to the start of the Propacetamol treatment mainly on care personnel.
Propacetamol Injection should be used with caution in case of: Chronic Alcoholism; Chronic Malnutrition (low reserves of hepatic glutathione); Dehydration; Middle & Terminal pregnant women, and possible pregnant women; Patient on a medication of antiepileptics.
Propacetamol should not be administered on early pregnant woman.
Propacetamol is excreted into breast milk in small quantities. No undesirable effect on nursing infants have been reported. Consequently, Propacetamol 1 g may be used in breast-feeding women.
Adverse reactions related to the route of administration may be observed: dizziness, malaise, moderate reduced blood pressure after intravenous injection, as well as local pain. Biological changes requiring blood tests have been observed. Certain blood elements (platelets) may be abnormally low and may result in bleeding of the nose or gums. Cases of serious hypersensitivity reactions have been reported during the administration of propacetamol in healthcare personnel previously sensitized during the handling of propacetamol. The adverse effects of Propacetamol are specific to Paracetamol. Skin rashes and allergic reactions may occur.
Hepatic enzyme inducer (Barbitals, Carbamazepine, Rifampin, etc.) can cause liver toxicity when combined with Propacetamol for long period of time.
Blood toxicity can be increased when administered in combination with NSAIDs.
Direction for Reconstitution: Shake the vial to loosen the powder. Add sufficient amount of diluent to attain the desired concentration. Use immediately the prepared solution (see table).
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Store at temperatures not exceeding 30°C.
N02BE05 - propacetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Febrex powd for inj 1 g
(+ 5 mL diluent) 10 × 1's
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