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

Paracetamol is an analgesic and antipyretic. It blocks the synthesis of prostaglandins in the central nervous system by inhibiting cyclooxygenase 1 and cyclooxygenase 2, acting on pain centers and thermoregulation. Does not show anti-inflammatory effect.The absence of influence on the synthesis of prostaglandins in peripheral tissues causes the absence of a negative influence on the water-salt metabolism (sodium and water retention) and the mucosa of the gastrointestinal tract.

Pharmacokinetics:Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It binds to plasma proteins by 15%. Paracetamol penetrates the blood-brain barrier. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is 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 in the form of glucuronides and sulfonated conjugates, less than 5 % excreted unchanged in the urine.

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 ingredient in the drug;

- severe dysfunction of the liver or kidney;

- children's age (up to 12 years).

Carefully:

Use with caution in benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcohol damage to the liver, glucose-b-phosphate dehydrogenase deficiency, alcoholism, pregnancy, lactation, and advanced age. The drug should not be taken concurrently with other paracetamol-containing drugs.

Dosing and Administration:

Adults, including the elderly and children over 12 years of age:

For 0.5-1 g, 1-2 hours after eating with plenty of fluids. Follow-up after 4-6 hours, the maximum daily dose to 4 grams per day.

The interval between receptions should be at least 4 hours. Do not take more than 8 tablets within 24 hours.

If symptoms persist, consult a physician.

Do not exceed the specified dose. If you have taken a dose exceeding the recommended dose, seek medical help, even if you are feeling well. Overdose of paracetamol can cause hepatic insufficiency.

The drug is not recommended for more than five days as an anesthetic and for more than three days as an antipyretic without prescription anddoctor's supervision. An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.

Side effects:

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

On the part of the digestive system: nausea, epigastric pain, increased activity of hepatic enzymes, hepatonecrosis,

From the endocrine system: hypoglycemia.

If unusual symptoms occur, consult a doctor.

Overdose:

Symptoms:

Pale skin, anorexia, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose).If you suspect an overdose, seek medical help immediately. 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 function abnormalities develop with lightning speed and can be complicated by renal failure (tubular necrosis).

Treatment:

The sufferer should do gastric lavage within the first 4 hours of poisoning, take adsorbents (Activated carbon) and see a doctor. Introduction donators SH -groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine - after 12 hours The need for additional therapeutic measures (further introduction of methionine, iv administration N-acetylcysteine) is determined at depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:The drug when taken during prolongs the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inductors of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, wdovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Sharing with other non-steroidal anti-inflammatory drugs increases nephrotoxic effect.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. The drug may reduce the activity of uricosuric drugs. Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol promotes the development of acute pancreatitis.

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

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

Myelotoxic drugs increase the manifestation of hematotoxicity of the prep.

Special instructions:

Before admission, consult a doctor in case;

- You have a serious liver or kidney disease;

- You take drugs against nausea and vomiting (metoclopramide, domperidone), as well as drugs that lower blood cholesterol (cholestyramine);

- You take anticoagulants and you need painkillers daily and for a long time. Paracetamol in this case, you can accept occasionally.

TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT CONSTITUTE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS STRONG TO THE CHRONIC CONSUMPTION OF ALCOHOL.

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

Form release / dosage:

Tablets 500 mg.

Packaging:

10 or 12 tablets in a contour cell package.

10 tablets in a contoured package without a cell.

1 or 2 contour mesh packages together with instructions for use in a pack of cardboard.

Contoured cell packs of 10 tablets or contour non-jawed packages with an equal number of instructions for use in a group package.

Storage conditions:

Store in a dry, protected from light and out of reach of children, at a temperature of 18 to 22 ° C.

Shelf life:

3 years. Do not use after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001927/08

Date of registration:18.03.2008

The owner of the registration certificate:Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC

Manufacturer: & nbsp

Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC Russia

Information update date: & nbsp08.10.2015

Illustrated instructions

Instructions

Paracetamol of Avexime (Paracetamol Aveksima)