Paracetamol, tablets 500 mg 20 pcs

Pharmgroup:

An analgesic non-narcotic.

Pharmic action:

A non-narcotic analgesic, blocks COX1 and COX2 primarily in the CNS, affecting the centers of pain and thermoregulation.

In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete lack of anti-inflammatory effect.

The lack of blocking effect on Pg synthesis in peripheral tissues explains its lack of negative effects on water-salt metabolism (Na+ and water retention) and gastrointestinal mucosa.

Indications

Active ingredient

Composition

Composition per tablet

active ingredient:

paracetamol – 500 mg;

excipients:

potato starch,

croscarmellose sodium (croscarmellose sodium),

povidone (polyvinylpyrrolidone low molecular weight medical),

Stearic acid,

Talc.

How to take, the dosage

Adults and adolescents over 12 years of age (body weight over 40 kg) single dose – 500 mg; maximum single dose – 1 g. The maximum daily dose is 4 g.
For children the dose of paracetamol is calculated according to the age and body weight.

Children aged 6-9 years (weight up to 30 kg): single dose – 250 mg (1/2 tablet); maximum daily dose – 1 g; aged 9-12 years (weight from 30 to 40 kg): single dose – 250-500 mg (1/2 tablet – 1 tablet), maximum daily dose – 2 g (4 tablets).

The frequency of administration is not more than 4 times a day with an interval of at least 4 hours.

In patients with hepatic and renal dysfunction, with benign hyperbilirubinemia, and in the elderly, the daily dose should be reduced and the interval between doses increased.

The treatment duration is not more than 3 days as antipyretic and not more than 5 days as analgesic. The drug treatment may be continued only after consulting the doctor.
Do not exceed the prescribed dose. Paracetamol overdose may cause hepatic failure.

Interaction

The drug when taken for a long time increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdose.

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

Ethanol promotes acute pancreatitis.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects. Concomitant use with other non-steroidal anti-inflammatory drugs increases nephrotoxic effect.

The concomitant use of paracetamol in high doses and salicylates increases the risk of kidney and bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% – risk of hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug. Metoclopramide and domperidone increase and cholestyramine decreases the absorption rate of paracetamol. The drug may decrease the activity of uricosuric drugs.

Special Instructions

Consult your doctor before you take this medicine:

to avoid anti-toxic liver damage, do not take paracetamol with alcoholic drinks, or with people who have a tendency to drink alcohol spirits chronically.

Peripheral blood count and liver function should be monitored during long-term treatment.

Contraindications

With caution: Use with caution in benign hyperbilirubinemia (incl.including Gilber’s syndrome), viral hepatitis, alcoholic liver damage, glucose-6-phosphate dehydrogenase deficiency, alcoholism, pregnancy, lactation, old age. The drug should not be taken simultaneously with other paracetamol-containing drugs.

Side effects

In the recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Allergic reactions (skin rash, pruritus, urticaria, Quincke’s edema), erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), dizziness, nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis; insomnia may sometimes be observed. When prolonged use in high doses – increased likelihood of impairment of liver and kidney function, as well as hematopoietic system.

Digestive system disorders: nausea, epigastric pain, increased liver enzymes activity, hepatonecrosis. Endocrine system: hypoglycemia. If unusual symptoms occur, it is necessary to consult a doctor.

Overdose

The signs of paracetamol overdose are nausea, vomiting, stomach pain, pale skin, anorexia. After a day or two, signs of liver damage are determined. In severe cases liver failure and coma develop. Specific antidote in paracetamol poisoning is N-acetylcysteine.

Symptoms: pale skin, anorexia, nausea, vomiting; hepatonecrosis (severity of necrosis depends directly on the degree of overdose). If overdose is suspected, it is necessary to seek medical attention immediately.

The toxic effects of the drug in adults may be observed after taking more than 10-15 g of paracetamol: increase of “hepatic” transaminases activity, increase of prothrombin time (12-48 hours after intake); the full clinical picture of liver damage becomes apparent after 1-6 days. Rarely, liver dysfunction develops fulminantly and may be complicated by renal failure (tubular necrosis).

Treatment: the victim should undergo gastric lavage during the first 4 hours of poisoning, take adsorbents (activated charcoal) and consult a physician, the administration of SH-group donators and precursors of glutathione synthesis – methionine in 8-9 hours after overdose and N-acetylcysteine – in 12 hours. The need for additional therapeutic measures (further methionine administration, intravenous N-acetylcysteine administration) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Similarities