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

Excipients: methylpiperbxybenzoate (nipagin or methylparaben), sorbitol liquid, glycerol (glycerin distilled), xanthan gum, dye azorubin (acid red 2C), strawberry flavoring (Strawberry flavor), sucrose (sugar refined sugar), purified water up to 100 ml .

Description:

A homogeneous suspension of pink color with the smell of strawberry. There are crystals in the suspension.

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

Non-narcotic analgesic, blocks cyclooxygenase (COX) 1 and COX 2 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 in practice; complete absence of anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration (TC_max) - 0.5-2 hours; maximum concentration (С_max) - 5-20 mcg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg.

Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis.In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% in unchanged form.

Indications:Applied in children from 1 month (for children 1-3 months the application for all indications is possible only according to the appointment of a pediatrician) as:

- antipyretics - for acute respiratory infections, influenza and children's infectious diseases (chicken pox, mumps, mumps, rubella, scarlet fever);

- analgesic (analgesic) means - with pain syndrome of mild and moderate intensity, including: headache and toothache, myalgia, arthralgia, earache in otitis, with sore throat, neuralgia, pain with injuries and burns.

Contraindications:

- hypersensitivity to Paracetamol or other components of the drug;

- marked violations of the liver and kidneys;

- diseases of the blood system;

- genetic absence of glucose-6-phosphate dehydrogenase;

- the period of newborns (up to 1 month).

Carefully:

- violations of the liver and kidneys, benign hyperbilirubinemia (incl.Gilbert syndrome), viral hepatitis, diabetes mellitus, alcoholic liver damage, alcoholism, pregnancy, lactation, early infancy (up to 3 months).

Dosing and Administration:

Inside, before meals undiluted, with water, 3-4 times a day at intervals of 4-6 hours. Before use, the contents of the bottle should be well shaken.

For convenience and accuracy of dosing, we recommend using a double-spoon: a large spoon contains 5 ml (120 mg paracetamol), a small spoon contains 2.5 ml (60 mg paracetamol), or a spoon with two labels: the lower one corresponds to 2.5 ml (60 mg paracetamol ) and the upper one - 5 ml (120 mg of paracetamol).

The dose of the drug depends on the age and body weight of the child.

A single dose of the drug is 10-15 mg / kg body weight. The maximum daily dose is not more than 60 mg / kg of the child's body weight.

Depending on the age of the drug prescribed in the following single doses: from 1 to 3 months - about 2 ml of suspension (about 50 mg of paracetamol), from 3 months to 1 year - 2.5-5 ml of suspension (60-120 mg of paracetamol), from 1 year to 6 years - 5-10 ml of suspension (120-240 mg of paracetamol), from 6 to 14 years-10-20 ml of suspension (240-480 mg of paracetamol).

The maximum duration of treatment without consulting a doctor is no more than 3 days as an antipyretic agent and not more than 5 days - asanesthetizing. Continue treatment with the drug after consulting a doctor.

Side effects:

Allergic reactions (including skin rash).

Overdose:

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. 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.

Treatment: gastric lavage no later than 4 hours after poisoning, intake of adsorbents (Activated carbon, polyphepan (hydrolysis lignin)). Introduction donators SH-groups and precursors of glutathione-methionine synthesis 8-9 h after overdose and acetylcysteine - after 12 h. The need for additional therapeutic measures (further introduction of methionine, intravenous administration acetylcysteine) is determined depending on the concentration of paracetamol in the blood,as well as on the time that has elapsed since it was received.

Interaction:

Reduces the effectiveness of uricosuric medicines.

The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver).

Inductors of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.

Ethanol promotes the development of acute pancreatitis.

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

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

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

Long-term sharing of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy andrenal papillary necrosis, the onset of the terminal stage of renal failure. 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:

Paracetamol should not be used concomitantly with other paracetamol-containing drugs, as this can cause an overdose of paracetamol.

With continued febrile syndrome in the presence of paracetamol for more than 3 days and pain syndrome for more than 5 days, a doctor's consultation is required. Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

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

The risk of liver damage increases in patients with alcoholic liver disease. Simultaneous reception with ethanol is not recommended.

The suspension contains 0.04 Xe sucrose per ml, which should be considered when treating patients with diabetes mellitus.

Form release / dosage:

Suspension for ingestion 120 mg / 5 ml.

Packaging:

100 ml in bottles of dark glass.

Each bottle or bottle with instructions for use and a spoon for taking medicines or a spoonful of dosage pharmacy is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008612/09

Date of registration:28.10.2009

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Paracetamol (Paracetamol)