Paracetamol oral solution 25mg/ml, 100ml

Composition

Per 1 ml of oral solution:

Active ingredient:

paracetamol 25.0 mg;

excipients:

sucrose 300.0 mg;

propylene glycol 400.0 mg;

methyl parahydroxybenzoate 0.8 mg;

citric acid 0.1 mg;

vanillin 1.0 mg;

purified water up to 1.0 ml

Pharmacological action

Pharmacological group: analgesic non-narcotic agent

Paracetamol has antipyretic and analgesic effects. Non-narcotic analgesic, blocks cyclooxygenase (COX) 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 COX, which explains the almost complete absence of an anti-inflammatory effect. Since paracetamol has an extremely small effect on prostaglandin synthesis in peripheral tissues, it does not change water and electrolyte metabolism and does not cause damage to the gastrointestinal mucosa.

Thus, paracetamol is particularly suitable for patients with a history of gastrointestinal diseases (such as patients with a history of gastrointestinal bleeding or elderly patients) or patients taking concomitant medications when inhibition of peripheral prostaglandins may be undesirable.

Indications

Used in children from 3 months to 12 years as:

• antipyretic – to reduce elevated body temperature against the background of colds, flu and children’s infectious diseases (including chickenpox, mumps, measles, rubella, scarlet fever);
• analgesic – for toothache, including teething, headache, ear pain with otitis media and sore throat.

For children of the 2nd-3rd month of life, a single dose is possible to reduce the temperature after vaccination.

If the temperature does not decrease, you should consult a doctor.

Use during pregnancy and lactation

Animal and human studies have not shown any risk of using the drug in pregnant women or the harmful effects of the drug on the development of the embryo and fetus. Paracetamol can be used during pregnancy, but it is advisable to use the minimum effective dose and the shortest course.

Breast-feeding period

In small amounts, it penetrates into breast milk. Studies have not established the harmful effects of paracetamol on the child’s body during breastfeeding, however, it should be used with caution.

Contraindications

Hypersensitivity to paracetamol or any other component of the drug in the anamnesis:

– age less than 2 months;

– severe liver and kidney function disorders.

With caution:

Mild to moderate renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert’s syndrome), glucose-6-phosphate dehydrogenase enzyme deficiency, dehydration, hypovolemia, anorexia, bulimia and cachexia (insufficient supply of glutathione in the liver), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, breastfeeding, old age, early infancy (up to 3 years month).

Before you start taking paracetamol, you should consult your doctor.

Side effects

Disorders of the blood and lymphatic system

• Very rare: thrombocytopenia, methemoglobinemia, anemia, hemolytic anemia, leukopenia, neutropenia.
• Frequency unknown: pancytopenia, agranulocytosis.

Immune system disorders: Very rare: skin rash, pruritus, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Laell’s syndrome), anaphylaxis.

Cardiac and vascular disorders: Very rare: hypotension, decreased or increased prothrombin index.

Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs).

Gastrointestinal disorders: Rare: abdominal pain, diarrhea, dyspepsia, bloating.

Liver and biliary tract disorders

• Very rare: impaired liver function, increased transaminase levels.
• Frequency unknown: liver failure.

Renal and urinary tract disorders: Frequency unknown: interstitial nephritis, papillary necrosis, increased creatinine (mainly secondary to hepatorenal syndrome).

With prolonged use in large doses, hepatotoxic and nephrotoxic effects are possible.

If you experience any of the listed side effects, stop taking the drug and immediately consult a doctor.

Interaction

If you or your child are already receiving other medications, you should consult your doctor before taking paracetamol.

Inducers of microsomal liver enzymes or potentially hepatotoxic substances (for example, alcohol, rifampicin, isoniazid, sleeping pills and antiepileptic drugs, including phenobarbital, phenytoin and carbamazepine) increase the toxicity of paracetamol, can lead to liver damage even at non-toxic doses of paracetamol, so liver function should be monitored.

Phenytoin reduces the effectiveness of paracetamol, therefore, patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses.

Reduces the effectiveness of uricosuric drugs.

Chloramphenicol. Paracetamol may increase the risk of increased concentrations of chloramphenicol.

Zidovudine. Paracetamol may increase the risk of developing neutropenia, and therefore, hematological parameters should be monitored. Simultaneous use is possible only after consulting a doctor.

Probenecid. Probenecid reduces the clearance of paracetamol by almost half, which requires a reduction in the dose of paracetamol.

Indirect anticoagulants

Repeated use of paracetamol for more than 4 days increases the anticoagulant effect. The international normalized ratio (INR) should be monitored during and after the end of concomitant use of paracetamol (especially in high doses and/or for a long time) and coumarin derivatives. Irregular use of paracetamol does not have a significant effect. Propanthelin and other drugs that slow gastric evacuation reduce the rate of absorption of paracetamol, which may delay or reduce the onset of the effect.

Metoclopramide and domperidone increase the rate of absorption of paracetamol and, accordingly, the onset of analgesic and antipyretic effects.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Ethanol contributes to the development of acute pancreatitis.

Long-term concomitant use of paracetamol and other NSAIDs increases the risk of developing” analgesic ” nephropathy and renal papillary necrosis, the onset of end-stage renal failure.

Concomitant long-term use of high-dose paracetamol 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 manifestations of hematotoxicity of the drug.

How to take, course of use and dosage

Only for oral use, with a large amount of liquid 1-2 hours after a meal.

Do not exceed the indicated dose.

You should take the lowest dose necessary to achieve the effect. The interval between meals should be at least 4 hours.

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

Children aged 2 months to 3 months. For the purpose of symptomatic relief of postvaccinal reactions, a single dose is 10-15 mg/kg. Apply 1-2 times a day with an interval of at least 4 hours. If fever persists after taking the second dose of the drug, you should consult a doctor. For all other indications, the use of the drug in patients of this age category is only on the recommendation of a doctor!

Children aged 3 months to 12 years. The maximum daily dose is 60 mg / kg, which is divided into several doses of 10-15 mg / kg. Apply one single dose 3-4 times a day with an interval of at least 4 hours. Take no more than four single doses in 24 hours. Do not exceed the indicated dose. The maximum duration of use of the drug without consulting a doctor is 3 days. If it is necessary to continue taking the drug for more than 3 days, a doctor’s consultation is required.

Do not exceed the recommended dose! In the absence of a therapeutic effect, a doctor’s consultation is mandatory.

Special patient groups

Patients with impaired renal function

Before taking paracetamol, patients with impaired renal function should consult a doctor. Limitations associated with the use of paracetamol-containing drugs in patients with impaired renal function are mainly related to the content of paracetamol in the drug.

Patients with impaired liver function

Before taking paracetamol, patients with impaired liver function should consult a doctor. Limitations associated with the use of paracetamol-containing drugs in patients with impaired liver function are mainly related to the content of paracetamol in the drug.

Overdose

Symptoms

The clinical picture of acute overdose develops within 24 hours after taking paracetamol.Gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and / or abdominal pain), pallor of the skin appear. With simultaneous use of 7.5 g or more to adults or more than 140 mg/kg to children, 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.

Ingestion of 5 g or more of paracetamol may cause liver damage in the presence of risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs that are inducers of microsomal liver enzymes; ethanol abuse, glutathione deficiency, digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia).12-48 hours after paracetamol use, there is an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration, and a decrease in prothrombin content. Clinical symptoms of liver damage appear 2 days after an overdose of the drug and reach a maximum on day 4-6.

Overdose can lead to intoxication, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking inducers of microsomal liver enzymes, and may develop lightning-fast hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, sometimes with a fatal outcome. In severe cases of overdose, as a result of liver failure, encephalopathy (impaired brain function), brain edema, bleeding, hypoglycemia, up to a fatal outcome can develop. It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (an admixture of blood or red blood cells in the urine), proteinuria (increased protein content in the urine), while severe liver damage may be absent. There were cases of cardiac arrhythmias, pancreatitis.

Treatment

Immediate hospitalization. If an overdose is suspected, even in the absence of pronounced first symptoms, it is necessary to stop using paracetamol and immediately seek medical help. It is necessary to determine the level of paracetamol in the blood plasma, but not earlier than 4 hours after overdose (earlier results are unreliable). Laboratory tests of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then every 24 hours. use of SH-group donors and glutathione synthesis precursors-methionine and acetylcysteine-is most effective in the first 8 hours.

Symptomatic treatment

Within 1 hour after overdose, gastric lavage and use of enterosorbents (activated charcoal, etc. ) are recommended. In most cases, the activity of microsomal liver enzymes normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required. use of acetylcysteine within 24 hours of overdose. The maximum protective effect is provided during the first 8 hours after an overdose; over time, the effectiveness of the antidote drops sharply.

If necessary, acetylcysteine is administered intravenously. If there is no vomiting before the patient is admitted to the hospital, methionine may be used.

The need for additional therapeutic measures (further use of methionine, intravenous use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases.

Special instructions

If you continue to have a fever syndrome with paracetamol for more than 3 days and pain syndrome for more than 5 days, you need to consult a doctor. The risk of developing liver damage increases in patients with alcoholic hepatosis. It distorts the results of laboratory tests for quantitative determination of glucose and uric acid in plasma.

During long-term treatment, it is necessary to monitor the peripheral blood picture and the functional state of the liver.

Children and adults with chronic diseases.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of paracetamol on the ability to drive a car or other mechanisms. However, due to possible adverse reactions, it is recommended to use caution while taking paracetamol when driving vehicles or other mechanisms.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C (do not freeze).

Keep out of reach of children.

Active ingredient

Paracetamol

Dosage form

oral solution