OXIMOL [Paracetamol] 120 mg\5 ml Oral suspension for children

instructions for the medical use of the medicinal product

OXIMOL

Tradename

Oximol, Оксимол

International non-proprietary name or generic name

Paracetamol, парацетамол

Dosage form

Oral suspension for children.

Composition per 5 ml of suspension:

active substance: paracetamol 120 mg;

excipients: sodium sorbitol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, microcrystalline cellulose, xanthan gum, ponceau 4R, polyoxyl 40 hydrogenated castor oil, hydrochloric acid, cherry flavor, purified water.

Pharmacotherapeutic group

Non-narcotic analgesic drug.

ATX code

N02BE01

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 pain and thermoregulation centers. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the lack of a significant anti-inflammatory effect. The drug does not have a 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 mcg / ml. Plasma protein binding is 15%. Penetrates the blood-brain barrier. Less than 2% of the dose of the drug taken by a nursing mother penetrates into breast milk. The therapeutically effective concentration of paracetamol in plasma is achieved when used at a dose of 10-15 mg / kg. 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 conjugate with glutathione, and then with cysteine ​​and mercapturic acid to form inactive metabolites. The main cytochrome P450 isoenzymes for this metabolic pathway are CYP2E1 (primarily), CYP1A2 and CYP3A4 (minor role). In case of glutathione deficiency, 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 metabolites of paracetamol (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.

Indications for use

It is used in children from 3 months to 12 years as:

• antipyretic - to reduce elevated body temperature due to colds, flu and childhood infectious diseases (chickenpox, mumps, measles, scarlet fever, etc.);

• pain reliever - for toothache, including teething or tooth extraction, headache, earache due to otitis and sore throat.

For children aged 2-3 months, a single dose is possible to reduce the temperature after vaccination. If the temperature does not decrease, a doctor's consultation is necessary.

Contraindications

• hypersensitivity to paracetamol or any other component of the drug;

• severe liver or kidney dysfunction;

• early infancy (up to 2 months).

Method of administration and dosage

The drug is taken orally before meals in undiluted form, washed down with plenty of liquid 1-2 hours after meals. Before use, shake the contents of the bottle thoroughly. The frequency of administration is no more than 4 times a day with an interval of at least 4 hours.

In children from 2 to 3 months, a single dose of 10-15 mg / kg is used for the symptomatic treatment of reactions to vaccination. If necessary, the dose can be repeated, but not earlier than 4 hours later. If the child's body temperature does not decrease after the second dose, you should consult a doctor. The use of the drug in patients of this age category for other indications is possible only on the recommendation of a doctor!

For children over 3 months, a single dose is 10-15 mg / kg of body weight, 3-4 times a day. If necessary, you can give the child the recommended dose every 4-6 hours, but no more than 4 doses within 24 hours.

The maximum daily dose is no more than 60 mg / kg of body weight.

Do not exceed the recommended dose. The maximum duration of use of the drug without consulting a doctor is 3 days. In the future, as well as in the absence of a therapeutic effect, it is necessary to consult a doctor.

In case of impaired renal function, the time interval between doses of the drug should be at least 8 hours with creatinine clearance less than 10 ml / min, at least 6 hours - with creatinine clearance 10-50 ml / min.

For accurate dosing of the drug, use the measuring syringe included in the package.

Using a measuring syringe:

1. Shake the suspension thoroughly.

2. Open the bottle cap.

3. Draw the suspension into the measuring syringe to the desired mark.

5. Close the bottle cap.

6. Give the drug to the child orally using 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 under running water and dry it disassembled at room temperature, out of the reach of children.

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

Depending on the child's weight and age, the single and maximum daily doses of Oxymol are prescribed in the following doses:

Body weight (kg) 4.5-6. Age - 2-3 months - Only as prescribed by a doctor.

Body weight (kg) 6-8. Age - 3-6 months - Single dose (4.0 ml) / (96 mg). Maximum daily (16 ml) / (384 mg).

Body weight (kg) 8-10. Age - 6-12 months - Single dose (5.0 ml) / (120 mg). Maximum daily (20 ml) / (480 mg).

Body weight (kg) 10-13. Age – 1-2 years – Single dose (7.0 ml) / (168 mg). Maximum daily (28 ml) / (672 mg).

Body weight (kg) 13-15. Age – 2-3 years – Single dose (9.0 ml) / (216 mg). Maximum daily (36 ml) / (864 mg).

Body weight (kg) 15-21. Age – 3-6 years – Single dose (10.0 ml) / (240 mg). Maximum daily (40 ml) / (960 mg).

Body weight (kg) 21-29. Age – 6-9 years – Single dose (14.0 ml) / (336 mg). Maximum daily (56 ml) / (1344 mg).

Body weight (kg) 29-42. Age – 9-12 years – Single dose (20.0 ml) / (480 mg). Maximum daily (80 ml) / (1920 mg).

Special instructions and precautions

Avoid concomitant use of paracetamol with other paracetamol-containing drugs, as this may cause an overdose of paracetamol.

The drug can be given to children aged 2 to 3 months only on prescription.

When using the drug for more than 5 days, peripheral blood counts and liver function should be monitored.

Paracetamol distorts the results of laboratory tests for glucose and uric acid in the blood plasma.

If fever persists for more than 3 days and pain for more than 5 days, consult your doctor.

Patients with glutathione deficiency are susceptible to overdose, and caution should be exercised. Cases of liver failure have been reported in patients with low glutathione levels, in particular in extremely emaciated patients suffering from anorexia, people with chronic alcoholism, or patients with a low body mass index.

The use of paracetamol in patients with low glutathione levels, such as in sepsis, may increase the risk of developing metabolic acidosis.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive a car or operate various mechanisms, or engage in other potentially dangerous activities that require increased attention and quick mental and motor reactions.

Side effect

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) effects; hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

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 causes the possibility of developing hepatotoxic effects with small overdoses.

Inhibitors of microsomal oxidation (including 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.

Enhances 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 promotes the development of acute pancreatitis.

Long-term combined use of paracetamol and nonsteroidal 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.

Overdose

If you think your child has taken more than the recommended dose, contact your doctor immediately, even if your child feels well. An overdose of paracetamol can cause liver failure.

Symptoms:

Acute overdose: pale skin, acute liver failure, gastrointestinal disorders (diarrhea, loss of appetite, nausea, vomiting, intestinal spasms, stomach pain), increased sweating. Symptoms of liver dysfunction may appear 12-48 hours after overdose. In case of 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); introduction of SH-group donors and precursors of glutathione synthesis - methionine within 8-9 hours after overdose and acetylcysteine - within 8 hours. The need for additional therapeutic measures (further administration of methionine, acetylcysteine, etc.) is determined depending on the concentration of paracetamol in the blood, as well as the time that has passed since its administration. Liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, normalization of liver enzymes occurs within 1-2 weeks. 

Storage conditions

Store at a temperature not exceeding 30°C. Keep out of reach of children.

Shelf life

4 years.

After opening the bottle, the shelf life of the suspension is 30 days.

Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.

Release form

120 ml of the preparation in PET bottles with a screw cap.

1 bottle and a measuring syringe together with instructions for use in a cardboard box.