Paracetamol

Paracetamol is one of the most widely used drugs to reduce fever and mild pain

Brand Tatkhimpharmpreparaty

In stock 1461 Items

Available since: 2019-09-19

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Clinical Pharmacology

Paracetamol is an analgesic and antipyretic agent. It blocks the synthesis of prostaglandins in the central nervous system by inhibiting cyclooxygenase 1 and cyclooxygenase 2, affecting the centers of pain and thermoregulation. Does not show anti-inflammatory effect. The lack of influence 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

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Associated with plasma proteins by 15%. Paracetamol penetrates the blood-brain barrier. Less than 1% of the paracetamol dose taken by the nursing mother passes into breast milk. A therapeutically effective plasma concentration of paracetamol is achieved when administered at a dose of 10–15 mg / kg body weight. The half-life is 1-4 hours. Paracetamol is metabolized in the liver and excreted in the urine, mainly as glucuronides and sulfonated conjugates, less than 5% is excreted unchanged in the urine.

Indications

Pain syndrome of low and moderate intensity of various genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea, pain with injuries, burns). Fever with infectious and inflammatory diseases.

Composition

Excipients: gelatin, potato starch, stearic acid, milk sugar (lactose).

Paracetamol is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Paracetamol	Tatkhimpharmpreparaty	Russia	pills
Paracetamol	Pharmstandard	Russia	pills
Children's Panadol	GlaxoSmithKline	UK	rectal suppositories
Panadol	GlaxoSmithKline	UK	pills
Efferalgan	UPSA SAS	France	rectal suppositories
Paracetamol	Pharmstandard	Russia	suspension
Paracetamol	Biochemist	Russia	rectal suppositories
Paracetamol	PFK Obnovlenie	Russia	pills
Paracetamol-Altfarm	Altfarm	Russia	rectal suppositories
Perfalgan	Bristol-Myers Squibb	USA	solution
Cefekon D	Nizhpharm	Russia	rectal suppositories
Cefekon H	Nizhpharm	Russia	rectal suppositories
Paracetamol	Synthesis AKOMP	Russia	syrup
Panadol	GlaxoSmithKline	UK	suspension
Efferalgan	UPSA SAS	France	effervescent pills
Efferalgan	UPSA SAS	France	syrup

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Dosage and Administration

Inside or rectally, in adults and adolescents weighing more than 60 kg, they are used in a single dose of 500 mg, up to 4 times a day. The maximum duration of treatment is 5-7 days.

Maximum doses: single - 1 g, daily - 4 g.

Single doses for oral administration for children aged 6-12 years - 250-500 mg, 1-5 years - 120-250 mg, from 3 months to 1 year - 60-120 mg, up to 3 months - 10 mg / kg. Single doses for rectal use in children aged 6-12 years - 250-500 mg, 1-5 years - 125-250 mg.

The frequency of use is 4 times / day with an interval of at least 4 hours. The maximum duration of treatment is 3 days.

Maximum dose: 4 single doses per day.

Adverse reactions

In recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Sometimes allergic reactions (skin rash, itching, hives, Quincke’s edema), exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), dizziness, nausea, epigastric pain can be observed; anemia, thrombocytopenia, agranulocytosis; insomnia. With prolonged use in large doses - increases the likelihood of impaired liver and kidney function, as well as the hematopoietic system.

From the digestive system: nausea, epigastric pain, increased liver enzymes, hepatonecrosis. On the part of the endocrine system: hypoglycemia. If you experience unusual symptoms, you should consult a doctor.

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

Drug interactions

With simultaneous use with inducers of liver microsomal enzymes, agents with hepatotoxic effects, there is a risk of enhancing the hepatotoxic effects of paracetamol.

When applied simultaneously with anticoagulants, a slight or moderately pronounced increase in prothrombin time is possible.

With simultaneous use of anticholinergic agents may decrease the absorption of paracetamol.

With simultaneous use with oral contraceptives accelerated excretion of paracetamol from the body and may decrease its analgesic action.

When used simultaneously with uricosuric agents, their effectiveness is reduced.

With the simultaneous use of Activated charcoal decreases the bioavailability of paracetamol.

With simultaneous use with diazepam may decrease the excretion of diazepam.

There are reports of the possibility of enhancing the myelodepressive effect of zidovudine with simultaneous use with paracetamol. A case of severe toxic liver damage is described.

Cases of manifestations of toxic action of paracetamol with simultaneous use with isoniazid are described.

With simultaneous use with carbamazepine, phenytoin, phenobarbital, primidone, the effectiveness of paracetamol decreases, which is caused by an increase in its metabolism (glucuronization and oxidation processes) and excretion from the body. Cases of hepatotoxicity with simultaneous use of paracetamol and phenobarbital are described.

If Kolestiramine is used for a period of less than 1 hour after taking paracetamol, the absorption of the latter may be reduced.

With simultaneous use with lamotrigine moderately increases the elimination of lamotrigine from the body.

With simultaneous use with metoclopramide may increase the absorption of paracetamol and increase its concentration in the blood plasma.

With simultaneous use of probenecid, a decrease in paracetamol clearance is possible; with rifampicin, sulfinpyrazone - possible increase in clearance of paracetamol due to an increase in its metabolism in the liver.

With simultaneous use with ethinyl estradiol increases the absorption of paracetamol from the intestine.

Pregnancy and Lactation

Paracetamol penetrates the placental barrier. To date, no negative effects of paracetamol on the fetus in humans have been observed.

Paracetamol is excreted in breast milk: the content in milk is 0.04-0.23% of the dose taken by the mother.

If paracetamol is used during pregnancy and lactation (breastfeeding), the expected benefit of therapy for the mother and the potential risk to the fetus or baby should be carefully weighed.

In experimental studies, the embryotoxic, teratogenic and mutagenic effects of paracetamol have not been established.

Special instructions

It is used with caution in patients with impaired liver and kidney function, with benign hyperbilirubinemia, and in elderly patients.

With long-term use of paracetamol, control of the pattern of peripheral blood and the functional state of the liver is necessary.

It is used to treat premenstrual tension syndrome in combination with pamabrom (diuretic, xanthine derivative) and mepyramine (histamine H blocker₁-receptors).

Overdosage

Signs of paracetamol overdose - nausea, vomiting, stomach pain, pale skin, anorexia. In a day or two, signs of liver damage are determined. In severe cases, liver failure and coma develops. A specific antidote for paracetamol poisoning is N-acetylcysteine.

Symptoms: pallor of the skin, anorexia, nausea, vomiting; hepatonecrosis (severity of necrosis is directly dependent on the degree of overdose). If you suspect an overdose, you should immediately seek medical help. The toxic effect of the drug in adults is possible after taking more than 10-15 g of paracetamol: an increase in the activity of liver transaminases, an increase in prothrombin time (12-48 hours after administration); A detailed clinical picture of liver damage occurs after 1-6 days. Rarely, liver dysfunction develops with lightning speed and may be complicated by renal failure (tubular necrosis).

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