Index of drugs

Short-term treatment of moderate pain (especially in the post-operative period) and short-term treatment of hyperthermia if the intravenous administration is justified by the clinical need for pain and / or fever, or if it is not possible to administer the drug by another route.

1 vial (50 ml) contains 500 mg of paracetamol; 1 vial (100 ml) contains 1000 mg of Paracetamol (1 ml of solution contains 10 mg of paracetamol).

An analgesic and antipyretic medication for intravenous infusion. It mainly works by inhibiting prostaglandin cyclooxygenase activity at o.u.n. (it does not impair its activity in peripheral tissues). Affects the thermoregulatory center in the hypothalamus. An analgesic effect occurs within 5-10 minutes after the start of administration. The strongest analgesic effect occurs within 1 h and lasts usually 4-6 h. The preparation reduces fever within 30 min after the start of administration, the antipyretic effect persists for at least 6 h. Maximum concentration of the drug in the blood is observed after completing the 15 minute infusion iv - after a dose of 500 mg - 15 μg / ml; after a dose of 1000 mg - 30 μg / ml. Paracetamol weakly binds to plasma proteins. The concentration in the cerebrospinal fluid is about 1.5 μg / ml 20 min after the end of the infusion of 1 g of paracetamol. Paracetamol is mainly metabolised in the liver (conjugation to glucuronides and sulphates) and with the participation of cytochrome P-450 (with the intermediate metabolite N-acetyl-p-benzoquinoline). The drug is excreted mainly in the urine (90%) in the form of glucuronides (60-80%) or sulphates (20-30%); less than 5% of the drug is excreted unchanged. T_0,5 is about 2.7 h. Paracetamol pharmacokinetic parameters observed in infants and older children are similar to those seen in adults, except for the half-life, which is shorter (1.5-2 h). In neonates, the half-life is longer than in infants (about 3.5 hours). The total excretion of paracetamol and its metabolites is identical in all age groups. Newborns, infants and children up to the age of 10 expel significantly less connections with glucuronic acid and sulphates than adults. In the case of severe renal failure (creatinine clearance 10-30 ml / min), the elimination time of paracetamol and its metabolites is slightly longer (T_0,5 = 2.5.3 h); the rate of elimination of connections with glucuronic acid and sulphates is three times slower than in healthy ones. The pharmacokinetic parameters and metabolism of paracetamol do not change in elderly patients.

Hypersensitivity to Paracetamol, propacetamol hydrochloride or other ingredients of the preparation. Severe hepatic failure.

It is recommended to use appropriate oral analgesia when it is possible to administer drugs in this way. It should be monitored if the patient is taking other drugs containing paracetamol. Caution should be exercised in patients with hepatic failure, severe renal impairment (creatinine clearance ≤ 30 ml / min), malnourished (low glutathione availability in the liver), dehydrated, alcohol disease. Do not use doses higher than recommended.

Clinical trials with use of paracetamol intravenously in pregnant women are limited, however, no adverse effects of oral paracetamol at the recommended doses in pregnant women or teratogenic or foetotoxic effects have been found. Intravenous paracetamol can be used during pregnancy when the benefit for the mother outweighs the potential risk to the fetus. The drug passes into breast milk in small amounts - the drug can be used during breastfeeding.

Rare: Malaise, decrease in blood pressure, increase in transaminases in the blood. Very rare: hypersensitivity reactions (skin rash, urticaria, anaphylactic shock), thrombocytopenia, leukopenia, neutropenia. Cases of erythema, redness (especially of the face), pruritus and tachycardia have been reported.

Intravenously.The 100 ml vial is intended for use only in adults, adolescents and children at birth. over 33 kg. The 50 ml vial is intended for use in neonates born at the time of infants and children at birth. up to 33 kg.Adolescents and adults about over 50 kg: single dose is 1 g (1 vial 100 ml) not more than 4 times a day. The minimum interval between doses is 4 hours. The maximum daily dose is 4 g.Children about the month of over 33 kg, adolescents and adults about less than 50 kg: single dose is 15 mg / kg (1.5 ml / kg) not more than 4 times a day. The maximum volume of a single dose - 75 ml. The minimum interval between doses is 4 hours. The maximum daily dose is 60 mg / kg. (do not exceed 3 g).Children about the month of 10-33 kg: single dose is 15 mg / kg (1.5 ml / kg) not more than 4 times a day. The maximum volume of a single dose - 49.5 ml. The minimum interval between doses is 4 hours. The maximum daily dose is 60 mg / kg. (do not exceed 2 g).Newborns born on time, babies, children about the month up to 10 kg: single dose is 7.5 mg / kg. (0.75 ml / kg) not more than 4 times a day. The maximum volume of a single dose - 7.5 ml. The minimum interval between doses is 4 hours. The maximum daily dose is 30 mg / kg. Due to the small volume of the preparation administered in this population, do not connect the glass vial / bag with the preparation directly to the infusion set. To measure appropriate to the mc. The child's volume should be used with a 5 or 10 ml syringe. There are no data on the use of the drug in premature babies. There is no need to modify the dosage of the drug in the elderly. In patients with severe renal impairment (creatinine clearance ≤ 30 ml / min), it is recommended to increase the minimum interval between doses up to 6 hours. In patients with hepatic failure, chronic alcoholism, long-term malnourishment (small glutathione reserves in the liver), the maximum daily dose of dehydrated is 3 g. The preparation should be administered in a 15-minute intravenous infusion. The drug can be diluted with 0.9% NaCl or 5% Glucose in a ratio of no more than 1:10. The solution thus prepared must be used within 1 h (including infusion time).