Paracetamol suspension 120mg / 5ml, 100ml

Paracetamol suspension 120mg / 5ml, 100ml; 'Pain syndrome of mild and moderate intensity, fever in infectious and inflammatory diseases (including viral infections), post-vaccination hyperthermia.

5 ml of suspension contains 120 mg of paracetamol.

In one bottle, 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 undiluted with plenty of liquid.

Shake well before use.

The frequency of admission is no more than 4 times a day with an interval of at least 4 hours.

The dose of paracetamol for children is calculated depending on age and body weight.

A single dose of paracetamol is 10-15 mg / kg of body weight, the daily dose is no more than 60 mg / kg of body weight.

For accurate dosing of the drug, depending on the proposed configuration, use a measuring spoon or a measuring syringe enclosed in the package.

In case of using a measuring syringe:

1. Shake the suspension thoroughly.

2. Open the bottle cap.

3. Insert the measuring syringe firmly into the hole of the adapter installed in the neck of the vial.

4. Turn the vial upside down and gently pull the plunger down, drawing the suspension into the measuring syringe to the desired mark.

5. Return the vial to its original position and remove the measuring syringe by gently turning it.

6. Give the drug to the child by mouth with a measuring syringe.

To ensure a smooth flow of the suspension into the oral cavity, slowly press the plunger.

After each use, rinse the measuring syringe in running water and dry disassembled at room temperature out of the reach of the child.

Store the measuring syringe in the package along with the drug.

Depending on the age, 'Paracetamol for children' is prescribed in the following single doses:

- from 1 to 3 months - for the symptomatic treatment of reactions to vaccination, a single dose of 2.5 ml of suspension is used. If necessary, the dose can be repeated, but not earlier than after 4 hours.

If the child's body temperature does not decrease after the second dose, a doctor should be consulted. Further use of the drug in children of this age for the treatment of post-vaccination hyperthermia, as well as use in children aged 1-3 months for other indications, is possible only under the supervision of a physician.

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 child's body weight;

- from 1 year to 6 years - 5-10 ml or 120-240 mg depending on the child's body weight - from 6 to 14 years old -10-20 ml or 240-480 mg depending on the child's body weight;

- for adults - a single dose of 20 ml no more than 4 times a day.

The duration of treatment is 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!

Paracetamol overdose can cause liver failure.

Composition for 5 ml of the preparation:

Active ingredient: paracetamol -120 mg.

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

- Individual hypersensitivity to the components of the drug;

- diseases of the blood system;

- genetic absence of glucose-6-phosphate dehydrogenase;

- sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;

- neonatal period (age up to 1 month).

Carefully

- hepatic and renal failure;

- benign hyperbilirubinemia (including Gilbert's syndrome);

- alcoholic liver damage, alcoholism;

- diabetes;

- pregnancy, lactation period;

- elderly age;

- early infancy (1-3 months).

Pharmacological properties

Pharmacodynamics. Non-narcotic analgesic, has analgesic and antipyretic effects.

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 has no negative effect on water-salt metabolism and the mucous membrane 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 ?g / ml. Communication with plasma proteins -15%. Penetrates the blood-brain barrier. Less than 2% of the dose taken by a nursing mother passes into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when it is used at a dose of 10-15 mg / kg.

It is metabolized in the liver: 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites, 17% undergoes hydroxylation to form 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 metabolic pathway are the isoenzyme CYP2E1 (mainly), CYP1A2 and CYP3A4 (minor role).

With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. Additional metabolic pathways are hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxyparacetamol, which are subsequently conjugated with glucuronic and sulfuric acid. In adults, glucuronidation predominates, in newborns (including premature babies) and small children - sulfation.

Conjugated paracetamol metabolites (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. The half-life is 2-3 hours. Within 24 hours, 85-95% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, 3% - unchanged. In elderly patients, paracetamol clearance decreases and the half-life increases.

Side effects

Nausea, vomiting, abdominal pain. Allergic reactions (including skin rash, itching, urticaria, Quincke's edema), leukopenia, agranulocytosis, thrombocytopenia. With prolonged use in high doses - hepatotoxic and nephrotoxic (interstitial nephritis and papillary necrosis) action; hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Overdose

If you think your child has taken more than the recommended dose, see a doctor immediately, even if the child is doing well. An overdose of paracetamol can cause the development of liver failure. Symptoms: Acute overdose: pallor of the skin, acute liver failure, gastrointestinal disturbances (diarrhea, loss of appetite, nausea, vomiting, intestinal cramps, stomach pain), increased sweating. Symptoms of liver dysfunction may appear 12 to 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. Chronic overdose: hepatotoxicity, nephrotoxicity. Treatment:gastric lavage no later than 4 hours after poisoning, intake of adsorbents (activated carbon); the introduction of SH-group donors and precursors of the synthesis of glutathione - methionine within 8-9 hours after an overdose and acetylcysteine ??- within 8 hours.The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as from the time elapsed after taking it.i.v. administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.i.v. administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.

Interaction with other medicinal products

Inducers 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 hepatotoxic effects with small overdoses. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects. The simultaneous long-term administration of high doses of paracetamol and salicylates increases the risk of developing kidney or bladder cancer. The combination with chloramphenicol leads to an increase in the toxic properties of the latter. Strengthens the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs. Long-term use of barbiturates reduces the effectiveness of paracetamol.Myelotoxic drugs increase the manifestations of paracetamol hematotoxicity. Ethanol contributes to 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 end-stage renal failure. Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Application during pregnancy and during breastfeeding

Paracetamol crosses the placenta, when taken in therapeutic dosages, the drug is safe for the fetus, in high doses it can have a hepatotoxic effect, therefore it is necessary to strictly observe the dosing regimen. During breastfeeding, the concentration in breast milk is low (1-2% of the mother's dose). No adverse effects on infants have been reported. Application is possible with strict adherence to the dosage regimen.

special instructions

Avoid the simultaneous use of paracetamol with other paracetamol-containing drugs, as this can cause an overdose of paracetamol. When using the drug for more than 5 days, the peripheral blood parameters and the functional state of the liver should be monitored. The drug contains sucrose and sorbitol, which should be taken into account when treating patients with diabetes mellitus (5 ml of suspension contains 0.25 bread units). Paracetamol distorts the results of laboratory tests of the content of glucose and uric acid in the blood plasma. If the fever continues for more than 3 days and the pain syndrome continues for more than 5 days, you should consult your doctor.

Influence on the ability to drive vehicles, mechanisms

The drug does not affect the ability to drive a car or to control various mechanisms, as well as to engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions.