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

Excipients: avicel RC-591 [cellulose microcrystalline, carmellose sodium] - 50 mg, xanthan gum (xanthan gum) - 7.5 mg, methyl parahydroxybenzoate (nipagin) - 5 mg, propylene glycol - 1 mg, sucrose (sugar) - 1650 mg, glycerol glycerol) - 630 mg, sorbitol (sorbitol food) - 1128.75 mg, orange flavor or strawberry flavor - 6.5 mg, water (purified water) - up to 5 ml.

Description:homogeneous suspension from light-gray or light gray with a yellowish tint of color to gray or gray with a yellowish tint of color with a characteristic fruity smell

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

Non-narcotic analgesic, has analgesic and antipyretic effect.

The drug blocks cyclooxygenase 1 and 2 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 the absence of a significant anti-inflammatory effect. The drug does not adversely affect the water-salt metabolism and mucosa of the gastrointestinal tract.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration is 0.5-2 hours, the maximum concentration is 5-20 μg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Less than 2% of the dose of the medication taken by the mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is applied at a dose of 10-15 mg / kg. Metabolized in the liver: 80% enters the conjugation reaction with glucuronic acid

acid and sulfates with the formation of inactive metabolites, 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione, and then with cysteine and mercapturic acid and form inactive metabolites.The main isoenzymes of cytochrome P450 for this pathway of metabolism are isoenzyme CYP2E1 (predominantly), CYP1A2 and CYP3A4 (a secondary role). With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis.

Additional ways of metabolism are hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxyparacetamol, which are subsequently conjugated to glucuronic and sulfuric acid.

In adults, glucuronation predominates, in newborns (including prematurity) and small children, sulfation. Conjugated metabolites of paracetamol (glucuronides, sulfates and conjugates with glutathione) have a low pharmacological (including toxic) activity.

Half-life is 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted, kidneys in the form of glucuronides and sulfates, 3% - unchanged. In elderly patients, clearance of paracetamol decreases and the half-life increases.

Indications:

Pain syndrome of mild and moderate intensity, fever in infectious and inflammatory diseases (including viral infections), postvaccinal hyperthermia.

Contraindications:

- individual hypersensitivity to the components of the drug;

- diseases of the blood system;

- genetic absence of glucose-6-phosphate dehydrogenase;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;

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

Carefully:

- hepatic and renal insufficiency;

- benign hyperbilirubinemia (including Gilbert's syndrome);

- alcoholic liver damage, alcoholism;

- diabetes;

- pregnancy, lactation;

- elderly age;

- early infancy (1-3 months).

Pregnancy and lactation:

Paracetamol penetrates the placenta, when taken in therapeutic dosages the drug is safe for the fetus, it can have a hepatotoxic effect in high doses, therefore it is necessary to strictly follow the dosing regimen.

Breastfeeding concentration in breast milk is low (1-2% of the maternal dose). Adverse effects on infants are not documented. Application is possible with strict adherence to the dosing regimen.

Dosing and Administration:

In 5 ml of the suspension contains 120 mg of paracetamol. In one vial the number of doses of 5 ml is: in 100 g - 16 doses, in 150 g - 24 doses and in 200 g - 32 doses.

The drug is taken orally before meals in un-diluted form, with plenty of liquid. Before use, the preparation is shaken carefully. Multiplicity of reception no more than 4 times a day with an interval of at least 4 hours.

The dose of paracetamol for children is calculated according to age and body weight. A single dose of paracetamol is 10-15 mg / kg of body weight, the daily dose is not more than 60 mg / kg of body weight.

To accurately dispense the drug, depending on the proposed equipment use a measuring spoon or a measuring syringe, enclosed in the package.

In the case of a measuring syringe:

1. Thoroughly shake the suspension.

2. Open the lid of the vial.

3. Tightly insert a measuring syringe into the hole of the adapter installed in the neck of the vial.

4. Flip the bottle upside down and gently pull the piston down, dialing the suspension into a measuring syringe to the desired mark.

5. Return the bottle to its original position and remove the measuring syringe, gently rotating it.

6. Give the medication to the child inside by means of a measuring syringe. To ensure a smooth flow of the suspension into the mouth, slowly press the plunger. After each use, wash the measuring syringe in running water and dry it in disassembled form at room temperature in a place inaccessible to the child.Store the measuring syringe in the package with the drug.

Depending on the age of "Paracetamol child" is prescribed in the following single doses:

- 1 to 3 months - for a symptomatic treatment of vaccination reactions a single dose of 2.5 ml of the suspension is used. If necessary, the dose can be repeated, but not earlier than 4 hours. If the child's body temperature does not decrease after a second dose, you should consult your doctor. Further use of the drug in children of this age for the treatment of postvaccinal hyperthermia, as well as use in children aged 1-3 months by other indications is possible only under the supervision of a doctor. If it is necessary to use the drug for a premature baby at the age of 1-3 months, the drug is prescribed only on the recommendation of a doctor.

- from 3 months to 1 year - 2.5-5 ml or 60-120 mg of paracetamol, depending on the weight of the child (see table below);

- from 1 to 6 years -5-10 ml or 120-240 mg depending on the weight of the child (see table below);

- from 6 to 14 years - 10-20 ml or 240-480 mg, depending on the weight of the child (see table below);

Weight of child's body	Single dose of the drug
4-8 kg	2.5 ml
8-16 kg	5 ml
16-32 kg	10 ml
more than 32 kg	15-20 ml

- adults - a single dose of 20 ml not more than 4 times a day.

Duration of treatment no more than 3 days as an antipyretic agent and no more than 5 days - as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor!

Do not exceed the prescribed dose! Overdose of paracetamol can cause hepatic insufficiency.

Side effects:

Nausea, vomiting, abdominal pain. Allergic reactions (including skin rash, itching, hives, Quincke's edema), leukopenia, agranulocytosis, thrombocytopenia.

With prolonged use in large doses - hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) action; hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Overdose:

If you think the baby has taken more than the recommended dose, consult a doctor immediately, even if the child is feeling well. Overdose of paracetamol can cause the development of hepatic insufficiency.

Symptoms:

Acute overdose: pallor of the skin, acute liver failure, gastrointestinal disorders (diarrhea, loss of appetite, nausea, vomiting, intestinal cramps, pain in the stomach), increased sweating.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 the absence of severe liver damage), arrhythmia, pancreatitis.

Chronic overdose: hepatotoxicity, nephrotoxicity.

Treatment: gastric lavage no later than 4 hours after poisoning, intake of adsorbents (Activated carbon); introduction of donators SH-groups and precursors of glutathione synthesis - methionine for 8-9 hours after the overdose and acetylcysteine -. for 8 hours The need for additional therapeutic activities (further introduction of methionine in / introduction 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:

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop a hepatotoxic effect with small overdoses.

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. Combination with chloramphenicol, leads to an increase in the toxic properties of the latter. '

Strengthens the effect of anticoagulants of indirect action and reduces the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Myelotoxic drugs increase the manifestation of hematotoxicity of paracetamol.

Ethanol promotes the development of acute pancreatitis.

Long-term combined use of paracetamol and non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal 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.

Special instructions:

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

When using the drug for more than 5 days should monitor the peripheral blood and the functional state of the liver.

The preparation contains sucrose and sorbitol, which should be considered in the treatment of patients with diabetes mellitus (5 ml of suspension contain 0.25 bread units). Paracetamol distorts the results of laboratory research content glucose and uric acid in the blood plasma.

When the fever lasts more than 3 days and pain syndrome for more than 5 days follows contact your doctor.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive a car or to control various mechanisms, as well as activities other potentially hazardous activities requiring increased attention and speed of mental and motor reactions.

Form release / dosage:

Suspension for oral administration [orangestrawberry], 120 mg / 5 ml.

Packaging:For 100 g or 150 g, or 200 g in a vial of dark glass. One bottle with instruction for application and a measuring spoon or a measuring syringe in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze!

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000094

Date of registration:05.02.2010

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Paracetamol for children (Paracetamol for kids)