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Paracetamol 500 mg 12 pcs. effervescent tablets

pharmachologic effect

Analgesic non-narcotic drug.

Composition and release form Paracetamol 500 mg 12 pcs. effervescent tablets

Tablets - 1 tablet:

Active ingredient: Paracetamol – 500,000 mg;
Excipients: anhydrous citric acid – 1114,000 mg; sodium bicarbonate – 942,000 mg; sodium carbonate anhydrous – 332,000 mg; sorbitol – 300,000 mg; sodium saccharinate – 7,000 mg; docusate sodium – 0.227 mg; povidone (K30) – 1.287 mg; sodium benzoate – 60.606 mg.

Effervescent tablets, 500 mg.

12 tablets per polypropylene tube, sealed with a plastic cap with silica gel and tamper evident.

2.4 tablets each in a contour cellless package made of a combined material based on aluminum foil laminated on the inside with polyethylene film (strip) or based on paper, aluminum foil and polyethylene film (strip).

The strips may have perforations for ease of opening the packaging.

1 tube with instructions for use is placed in a cardboard pack.

6, 8 contour cellless packages (strip) of 2 tablets each or 3, 4 contour cellless packages (strip) of 4 tablets each with instructions for use are placed in a cardboard pack.

Description of the dosage form

Round flat-cylindrical tablets from white to white with a yellowish tint with a chamfer. Light roughness and marbling are allowed.

Prepared solution: transparent or slightly opalescent colorless solution.

Characteristic

Round tablets from white to white with a yellowish tint.

Directions for use and doses

Inside. Dissolve the tablet in a glass of water (200 ml). Do not chew or swallow the tablets. Usually take 1-2 tablets 2-3 times a day at intervals of at least 4 hours.

The maximum single dose is 2 tablets (1 g), the maximum daily dose is 8 tablets (4 g), which corresponds to 10-15 mg/kg body weight for a single dose, and 75 mg/kg body weight for a maximum daily dose.

If renal function is impaired, the time interval between doses of the drug should be at least 8 hours if the creatinine clearance is less than 10 ml/min, and at least 6 hours if the creatinine clearance is 10-50 ml/min.

In patients with chronic or compensated active liver diseases, especially those accompanied by liver failure, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), dehydration or body weight less than 50 kg, the daily dose should not exceed 3 g, i.e. . 6 tablets.

The drug should be used with caution in children and patients weighing less than 50 kg to avoid the risk of exceeding the recommended dose.

The duration of use without consulting a doctor is no more than 5 days when prescribed as an analgesic and 3 days as an antipyretic.

Pharmacodynamics

Paracetamol (paraaminophenol derivative) has analgesic, antipyretic and weak anti-inflammatory effects. The exact mechanism of the analgesic and antipyretic effect of paracetamol has not been established. Apparently, it includes central and peripheral components.

The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains its almost complete lack of anti-inflammatory effect. The drug does not have a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract due to the lack of influence on the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics

Absorption

After oral administration, paracetamol is absorbed quickly and completely. Cmax (maximum concentration in blood plasma) is achieved 10-60 minutes after administration.

Distribution

Paracetamol is quickly distributed in all tissues. The concentration in blood, saliva and plasma is the same. Plasma protein binding is negligible.

Metabolism

Paracetamol is mainly metabolized in the liver. There are two main metabolic pathways producing glucuronides and sulfates. The latter is mainly used if the dose of paracetamol exceeds the therapeutic dose.

A small amount of paracetamol is metabolized by the cytochrome P450 isoenzyme to form the N-acetylbenzoquinoneimine intermediate, which under normal conditions is rapidly detoxified by glutathione and excreted in the urine after binding to cysteine and mercaptopuric acid. However, with massive intoxication, the content of this toxic metabolite increases.

Removal

It is carried out mainly with urine. 90% of the dose of paracetamol taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60 to 80%) and sulfate (20 to 30%). Less than 5% is excreted unchanged. Period

half-life is about 2 hours. In case of severe renal dysfunction (creatinine clearance less than 30 ml/min), the elimination of paracetamol and its metabolites is delayed.

Indications for use Paracetamol 500 mg 12 pcs. effervescent tablets

Moderate or mild pain syndrome (headache, toothache, migraine pain, neuralgia, muscle pain, lower back pain, pain from injuries and burns, sore throat, painful menstruation).

Increased body temperature during colds and other infectious and inflammatory diseases.

Contraindications

Hypersensitivity to paracetamol, propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug, severe liver failure or decompensated liver disease in the acute stage, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy (I and III trimester) and lactation period, children under 12 years of age (body weight not less than 50 kg).

Carefully:

Severe renal failure (creatinine clearance

Application Paracetamol 500 mg 12 pcs. effervescent tablets during pregnancy and breastfeeding

The use of the drug is contraindicated in the first and third trimesters of pregnancy and during breastfeeding. The use of the drug in the second trimester of pregnancy is possible after consultation with a doctor in order to assess the expected benefit for the mother and the possible risk for the fetus.

special instructions

To avoid overdose, the content of paracetamol in other drugs that the patient takes simultaneously with Paracetamol should be taken into account. Taking paracetamol in doses higher than recommended can cause severe liver damage.

If fever continues during the use of paracetamol for more than 3 days, and pain continues for more than 5 days, a doctor’s consultation is required.

Taking Paracetamol may distort laboratory test results when quantifying the content of glucose and uric acid in blood plasma.

To avoid toxic liver damage, paracetamol should not be combined with alcoholic beverages, or taken by persons prone to chronic alcohol consumption.

The risk of developing liver damage increases in patients with alcoholic hepatosis.

With prolonged use of the drug, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

Paracetamol can cause serious skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, which can be fatal. At the first appearance of a rash or other hypersensitivity reactions, use of the drug should be discontinued.

Also, the use of paracetamol should be discontinued if acute viral hepatitis is detected in the patient.

Paracetamol contains 412.4 mg sodium per tablet, which should be taken into account by patients on a strict low-salt diet.

Since the drug contains sorbitol, it should not be used in cases of sucrase/isomaltase deficiency, fructose intolerance, or glucose-galactose malabsorption.

Overdose

In case of overdose, intoxication is possible, especially in children, patients with liver diseases (caused by chronic alcoholism), in patients with malnutrition, as well as in patients taking enzyme inducers, which can develop fulminant hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases - sometimes with death. The clinical picture of acute overdose develops within 24 hours after taking the drug.

Symptoms: gastrointestinal disorders (nausea, vomiting, loss of appetite, abdominal discomfort and/or abdominal pain), pale skin, sweating, malaise. When administered simultaneously to adults of 7.5 g or more or to children of more than 140 mg/kg, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after the administration of paracetamol, there is an increase in the activity of “liver” transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in prothrombin concentration. The full clinical picture of liver damage appears after 1-2 days and reaches a maximum on days 3-4.

Treatment: immediate hospitalization, determination of the quantitative content of paracetamol in the blood plasma before starting treatment (as early as possible after an overdose), gastric lavage, administration of SH-group donors and precursors for the synthesis of glutathione - methionine within 8 hours after an overdose. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration. Symptomatic treatment. Liver tests should be performed at the start of treatment and then every 24 hours. In most cases, liver transaminase activity returns to normal within 1-2 weeks. In very severe cases, a liver transplant may be required.

Side effects Paracetamol 500 mg 12 pcs. effervescent tablets

When using the drug, the following side effects were observed (frequency not established):

Allergic reactions: hypersensitivity reactions, skin itching, rash on the skin and mucous membranes (erythema or urticaria), Quincke's edema, exudative erythema multiforme (including Steven-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, acute generalized exanthematous pustulosis.

From the central and peripheral nervous system (when taking high doses): dizziness, psychomotor agitation and disturbance of orientation in space and time.

From the digestive system: nausea, diarrhea, epigastric pain, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the hematopoietic organs: anemia (cyanosis), sulfohemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia, neutropenia, leukopenia.

Other: decreased blood pressure (as a symptom of anaphylaxis), changes in prothrombin time and international normalized ratio (INR).

Drug interactions

Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses.

Probenecid almost halves the clearance of paracetamol, inhibiting the process of its conjugation with glucuronic acid. If administered concomitantly, consider reducing the dose of paracetamol.

Caution should be exercised during the simultaneous use of paracetamol and inducers of microsomal liver enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants).

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

Salicylamide may increase the half-life of paracetamol.

INR monitoring should be carried out during and after the cessation of simultaneous use of paracetamol (especially in high doses and/or for a long time) and coumarins (for example, warfarin), since paracetamol when taken at a dose of 4 g / day for at least 4- x days may enhance the effect of indirect anticoagulants and increase the risk of bleeding. If necessary, adjust the dose of anticoagulants.