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

Pharmacokinetics:Quickly absorbed from the gastrointestinal tract, binds to plasma proteins. Half-life (T1 / 2) from plasma 1-4 hours Metabolised in the liver with the formation of glucuronide and paracetamol sulfate.It is excreted by the kidneys mainly in the form of conjugation products, less than 5% is excreted unchanged.

Indications:

- elevated body temperature for colds and other infectious and inflammatory diseases (over 38 ° C);

- pain syndrome of mild and moderate severity of different localization (headache, dental, migraine pain, back pain, neuralgia, myalgia).

Contraindications:

Hypersensitivity to paracetamol.

Children up to 6 years of age-for this dosage form.

Carefully:

Renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, alcoholism, pregnancy, lactation, elderly age, deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

It is used internally for 0.5 g (1 tablet) up to 4 times a day. The maximum single dose of 1 g (2 tablets), daily - 4 g (8 tablets). Duration of treatment as an antipyretic agent - no more than 3 days; as an anesthetic - no more than 5 days. An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of the attending physician.

Side effects:In therapeutic doses, the drug is usually well tolerated.Sometimes allergic reactions in the form of skin rashes, agranulocytosis, thrombocytopenia, anemia, renal colic, aseptic pyuria, interstitial glomerulonephritis. With prolonged use in high doses, hepatotoxic and nephrotoxic effects are possible.

Overdose:

In the case of acute drug overdose, the following symptoms occur: pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis (within the first 24 hours after administration). Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: introduction of 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 depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Inductors of microsomal liver enzymes (phenytoin, barbiturates, carbamazepine, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants, zidovudine and others), ethanol, hepatotoxic drugs increase the risk of developed hepatotoxic effects of paracetamol.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. When taking concomitantly with salicylates, the likelihood of developing a nephrotoxic effect increases.

When combined with paracetamol, the toxic effects of chloramphenicol are enhanced. Paracetamol strengthens the effect of methotrexate, m-holinoblokatorov, antidepressants (sedative effect), anticoagulants of indirect action (increased prothrombin time), systemic corticosteroids (increases the risk of ulcerogenic effects), oral hypoglycemic agents (blood sugar is lowered); reduces the effectiveness of uricosuric drugs and lisinopril. Paracetamol reduces the absorption of tetracyclines (the interval between doses should be at least 2 hours) and accelerates the excretion of lamotrigine.

With the combined use of paracetamol with MAO inhibitors, a sudden increase in blood pressure may occur, and in combination with organic nitrates, it may drop dramatically.

When combined with activated charcoal, antacid and anticholinergic agents, the absorption and effectiveness of paracetamol is reduced, and its absorption also decreases with the administration of colestyramine (with an interval of less than one hour between doses). Metoclopramide increases the absorption of paracetamol (it is also possible to increase its concentration in the blood plasma). Oral contraceptives accelerate the excretion of paracetamol and reduce its analgesic effect, and ethinyl estradiol increases its absorption from the intestine.

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

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Allowed for use during pregnancy and breastfeeding (short course under the supervision of a doctor).

Use with caution in patients with impaired liver or kidney function. To avoid toxic damage to the liver paracetamol should not be combined with the reception of alcoholic beverages, but also to people prone to chronic alcohol consumption.

With long-term use of the drug (more than 5-7 consecutive days), it is necessary to monitor the parameters of peripheral blood and the functional state of the liver.

Form release / dosage:

Tablets 500 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered ,.

1 or 2 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N000926 / 01

Date of registration:06.10.2008

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp07.10.2015

Illustrated instructions

Instructions

Paracetamol (Paracetamol)