Paracetamol - instructions for use, dose, side effects, contraindications

Excipients: povidone (polyvinylpyrrolidone low molecular weight medical) 12600 ± 2700 - 5.36 mg or 13.4 mg, potato starch - 10.7 mg or 26.75 mg, silicon dioxide colloid (aerosil) - 2.2 mg or 5.5 mg, calcium stearate -1.74 mg or 4.35 mg.

Description:tablets white or white with a creamy shade of color round flat-cylindrical shape, with a facet and a risk

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

Non-narcotic analgesic, blocks cyclooxygenase 1 and cyclooxygenase 2 predominantly in the central nervous system, affecting pain centers and thermoregulation.In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on the water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration in the plasma is 0.5-2 h; the maximum concentration in the plasma is 5-20 μg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier.

Metabolised in the liver (90-95%) in three main ways: 80 % reacts conjugation with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. In the absence of glutathione, these metabolites may be blockedenzyme systems of hepatocytesand call them necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life is 1-4 hours.It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases.

Indications:

Feverish syndrome on the background of infectious diseases; pain syndrome (mild and moderate): arthralgia, myalgia, neuralgia, migraine, dental and headache, algodismenorea.

Contraindications:

Hypersensitivity to paracetamol or any other component of the drug; children's age till 6 years.

Carefully:

Renal or hepatic insufficiency, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, breast-feeding period, elderly age, deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Inside, with a lot of liquid, 1-2 hours after eating.

Adults and children over 12 years of age receive a single dose of 500 mg; the maximum single dose is 1 g. The multiplicity of the destination is up to 4 times a day. The maximum daily dose is 4 g. The maximum duration of application for febrile syndrome is 3 days, with pain syndrome - 5 days.

Children over 6 years of single dose - 200 mg. Multiplicity of destination - up to 4 times a day.The interval between each reception is at least 4 hours.

Do not take more than 8 tablets within 24 hours. If symptoms persist, consult a physician.

Side effects:

Allergic reactions: skin rash, itching, angioedema.

Disorders of hematopoiesis (anemia, thrombocytopenia, methemoglobinemia).

Do not exceed the indicated dose! If you took a dose exceeding the recommended doseseek medical help, even if you are feeling well. Overdose of paracetamol can cause hepatic insufficiency.

The drug is not recommended for use for more than 3-5 days due to an increased likelihood of impaired liver and kidney function.

Overdose:

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe cases, hepatic failure develops with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis; arrhythmia, pancreatitis.Hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: stop taking the drug, do a lavage, take Activated carbon.

Further therapeutic measures should be carried out in the setting of a medical institution: the introduction of donators SH - groups and precursors of the synthesis of glutathione - methionine for 8-9 hours after an overdose and acetylcysteine - for 8 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous acetylcysteine) is determined depending on the concentration of paracetamol in the blood, and from the time that has elapsed since it was received.

Interaction:

Reduces the effectiveness of uricosuric medicines.

The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Inductors of microsomal liver enzymes (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites,which causes the possibility of developing severe intoxication even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol promotes the development of acute pancreatitis.

Inhibitors of microsomal liver enzymes (including cimetidine) reduce the risk of hepatotoxic effects.

Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and kidneypapillary necrosis, the onset of the terminal stage of renal failure.

Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

The risk of liver damage increases in patients with alcoholic liver disease. Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

During long-term use, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

Simultaneous reception of paracetamol with ethanol is not recommended.

The drug should not be taken concurrently with other paracetamol-containing drugs.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive vehicles, mechanisms.

Form release / dosage:

Paracetamol tablets are 200 mg and 500 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and foil of aluminum printed lacquered or contour non-cellular package of paper with polyethylene coating or from paper-based blanks for contour non-jagged packs of medicines.

Contour non-cellular packages, together with an equal number of instructions for use, are placed in a group package.

By 1 or 2, or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001927

Date of registration:02.10.2012

The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia

Manufacturer: & nbsp

DALHIMFARM, OJSC Russia

Information update date: & nbsp02.10.2015

Illustrated instructions

Instructions

Paracetamol (Paracetamol)