Short-term treatment of moderate pain, particularly in the post-operative period, and short-term treatment of fever, when intravenous administration is warranted by a clinically urgent need to combat pain or hyperthermia and (or) when drug delivery is not possible.
Composition:
1 ml contains 10 mg of paracetamol. The medicine contains sodium 1.22 mg (0.05 mmol) / ml.
Action:
Analgesic and antipyretic. The exact mechanism of analgesic and antipyretic action of Paracetamol has not yet been established. It may include central and peripheral effects. The drug begins to have analgesia within 5-10 minutes after administration. The strongest analgesic effect occurs within 1 h and lasts usually 4-6 h. The drug reduces fever within 30 min after administration. The antipyretic effect persists for at least 6 h. Maximum plasma concentration of paracetamol (Cmax), observed at the end of a 15-minute intravenous infusion of 500 mg and 1 g of Paracetamol, is approximately 15 μg / ml and 30 μg / ml, respectively. Paracetamol weakly binds to plasma proteins (approximately 10%). Twenty minutes after the end of infusion of 1 g of paracetamol, a significant concentration of paracetamol in the cerebrospinal fluid (approximately 1.5 μg / ml) was observed. Paracetamol is primarily metabolised in the liver by the following two major hepatic metabolic pathways: glucuronidation and sulfuric acid conjugation. The coupling with sulfuric acid undergoes rapid saturation after using doses greater than the therapeutic doses. Paracetamol metabolites are mainly excreted in the urine. 90% of the administered dose is excreted within 24 h, mainly in the form of a conjugate - glucuronide (60-80%) and sulphate (20-30%). Less than 5% is excreted unchanged. T0,5 in plasma is about 2.7 h in adults, 1.5-2 h in infants and children, and in newborns 3.5 h.
Contraindications:
Hypersensitivity to the active substance, propacetamol hydrochloride (paracetamol precursor) or to any of the excipients. Severe hepatic failure.
Precautions:
Paracetamol should be used with extreme caution in the following cases: hepatic failure, severe renal impairment (creatinine clearance ≤ 30 ml / min), chronic alcoholism, chronic malnutrition (small glutathione reserves in the liver), dehydration and in patients with genetically determined dehydrogenase deficiency glucose-6-phosphate (favism, after the administration of paracetamol, it is possible that haemolytic anemia occurs due to a reduction in the allocation of glutathione). It is recommended to use appropriate oral analgesia as soon as possible. To avoid overdose, check that your other medicines contain paracetamol or propecetamol hydrochloride. Administration of higher than recommended doses carries a risk of very severe liver damage. Clinical signs and symptoms of liver damage (including fulminant hepatitis, liver failure, congestive hepatitis, cytolytic hepatitis) usually appear after 2 days, with the maximum severity usually occurring after 4-6 days after administration. There are no data on the safety and efficacy of the drug in premature babies. The medicine contains sodium 61 mg (2.7 mmol) / 50 ml, 122 mg (5.3 mmol) / 100 ml, which should be taken into account for patients on a low sodium diet.
Pregnancy and lactation:
The drug can be used during pregnancy only after careful assessment of the risk / benefit ratio. Clinical trials in the use of intravenous paracetamol are limited. However, the results of epidemiological studies on the use of oral paracetamol in therapeutic doses do not indicate any adverse effects in pregnant women or on the health of the fetus or newborn. After oral administration, paracetamol is excreted in breast milk in small amounts. No adverse reactions were found in breastfed infants. Therefore, the drug can be used in women who are breastfeeding.
Side effects:
Rare: hypotension, increased liver transaminases, malaise. Very rare: thrombocytopenia, leukopenia, neutropenia; hypersensitivity reactions (from an ordinary skin rash or urticaria to anaphylactic shock, which requires immediate discontinuation of treatment). Not known: erythema, pruritus; hot flushes; tachycardia. Clinical trials have reported frequent side effects at the injection site (pain and burning sensation).
Dosage:
Intravenously. Newborns born on term, infants, and children at birth. ≤10 kg: administered dose: 7.5 mg / kg, volume to be administered: 0.75 ml / kg, maximum daily dose: 30 mg / kg Children about the month of > 10 kg to ≤33 kg: administered dose: 15 mg / kg, volume to be administered: 1.5 ml / kg, maximum daily dose: 60 mg / kg, no more than 2 g. Children, adolescents, adults about the month of > 33 kg to ≤50 kg: administered dose: 15 mg / kg, volume to be administered: 1.5 ml / kg, maximum daily dose: 60 mg / kg, no more than 3 g. Youth, adults about mc. > 50 kg: administered dose: 1 g, volume to be administered: 100 ml, maximum daily dose: 4 g. The minimum interval between each administration is at least 4 hours. Minimum interval between each administration in patients with severe renal impairment (creatinine clearance ≤ 30 ml / min) is at least 6 h; a dose reduction is recommended in these patients. Adult patients with hepatic impairment, chronic alcoholism, chronic malnutrition (small glutathione reserves in the liver) or dehydration must not administer a maximum daily dose of more than 3 g. Do not administer more than 4 doses over 24 hours. The solution is given as an intravenous infusion lasting 15 min.
(C)
