Paracetamol: instructions for use, indications, contraindications, side effects, dosage for children, adults. Paracetamol: instructions for use, indications, contraindications, side effects, dosage for children, adults Children's Paracetamol: instructions

in a blister pack 5 pcs.; in a cardboard pack 2 packs.

Description of the dosage form

Suppositories are white or white with a creamy or yellowish tint, torpedo-shaped.

Pharmacodynamics

Paracetamol has analgesic and antipyretic effects. Blocks cyclooxygenase in the central nervous system, affecting 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 (sodium and water retention) and the gastrointestinal mucosa.

Pharmacokinetics

Absorption is high, quickly absorbed from the gastrointestinal tract. The period to reach Cmax is 30–60 minutes, binding to plasma proteins is 15%. Penetrates through the BBB. The volume of distribution and bioavailability in children and neonates are similar to those in adults.

Metabolized in the liver: 80% - enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% - undergoes hydroxylation to form active metabolites, which conjugate with glutathione and form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In newborns in the first two days of life and in children 3–10 years of age, the main metabolite of paracetamol is paracetamol sulfate; in children 12 years of age and older, it is conjugated glucuronide.

T1/2 - 2–3 hours. Within 24 hours, 85–88% of paracetamol is excreted by the kidneys in the form of glucuronides and sulfates, unchanged - 3%. There is no significant age difference in the rate of elimination of paracetamol and in total number There is no drug that is excreted in the urine.

Paracetamol-Altpharm: Indications

Used in children from 3 months to 12 years as:

antipyretic for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by an increase in body temperature;

painkiller for pain syndrome weak and moderate intensity, incl. head and toothache, muscle pain, neuralgia, pain from injuries and burns.

In children from 1 to 3 months, a single dose of the drug can be taken to reduce fever after vaccination.

Paracetamol-Altpharm: Contraindications

hypersensitivity to the components of the drug;

age up to 1 month of life.

With caution:

liver and kidney dysfunction;

Gilbert's syndrome; Dubin-Johnson and Rotor;

diseases of the blood system (anemia, thrombocytopenia, leukopenia);

genetic absence of the enzyme glucose-6-phosphate dehydrogenase.

Directions for use and doses

Rectally, after a cleansing enema or spontaneous bowel movement. The dosage of the drug is calculated depending on age and body weight, in accordance with the table. A single dose is 10–15 mg/kg 2–3 times a day every 4–6 hours. Maximum daily dose paracetamol should not exceed 60 mg/kg.

Dosage of the drug for children of different ages

Paracetamol-Altpharm: Side effects

From the gastrointestinal tract: nausea, vomiting, abdominal pain.

Allergic reactions: itching, rash on the skin and mucous membranes, urticaria, Quincke's edema.

From the hematopoietic organs: anemia, leukopenia, agranulocytosis, thrombocytopenia.

At long-term use in large doses - hepatotoxic and nephrotoxic effects ( interstitial nephritis, papillary necrosis), hemolytic anemia.

Composition and release form

Suppositories - 1 soup:

Active ingredient: paracetamol - 50 mg.

5 pieces each in a blister pack made of polyvinyl chloride film. Two contour packages along with instructions for use in a cardboard pack.

Description of the dosage form

Suppositories are white to white with a creamy or yellowish tint, torpedo-shaped without visible inclusions on a longitudinal section.

Characteristic

Round tablets from white to white with a yellowish tint.

Pharmacokinetics

Paracetamol, when taken orally, is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum level of concentration in the blood is reached after 30-60 minutes. When paracetamol is administered rectally, the completeness of its absorption may be lower than after oral administration.

Paracetamol is quickly and evenly distributed throughout the tissues of the body. 10-15% of the dose taken is bound to plasma proteins. The volume of distribution and bioavailability in children and adults do not differ significantly. The drug penetrates the placental barrier. IN breast milk Feeding mothers receive less than 1% of the dose taken.

Paracetamol is metabolized by liver microsomal enzymes, about 80% forms conjugates with glucuronic acid and sulfates, up to 17% undergoes hydroxylation to form active metabolites that are conjugated with glutathione. With an overdose or deficiency of glutathione, these metabolites can cause necrosis of hepatocytes.

The half-life of paracetamol is 1.5-2.5 hours. It may increase in patients with pronounced violation liver function and elderly patients. 24 hours after administration, 85-90% of paracetamol is excreted in the urine in the form of glucoronides and sulfates, and 3% unchanged.

In children under 10-12 years of age, the formation of conjugates with sulfates is the main route of metabolism and excretion of paracetamol. The likelihood of hepatotoxicity in children is lower than in adults. Other pharmacokinetic parameters of adults and children do not differ.

Pharmacodynamics

Paracetamol contained in suppositories has antipyretic and analgesic effects. The drug blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. Body heat loss during fever increases as a result of vasodilation and increased peripheral blood flow. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of the anti-inflammatory effect of the drug.

Instructions

The drug is administered rectally (injected into the rectum). Before using the suppository, it is recommended to empty the intestines.

The duration of treatment is no more than 3 days when prescribed as an antipyretic and no more than 5 days when prescribed as an analgesic. Further treatment with the drug is possible only after consultation with a doctor.

Indications for use

Paracetamol-Altpharm suppositories are used in adults and children from 3 months of life (in children from 1 to 3 months of life - only as prescribed by a doctor):

• As an antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by an increase in body temperature;
• as an analgesic for pain of mild or moderate intensity, including: headaches and toothaches, muscle pain, neuralgia, pain from injuries and burns.

Contraindications for use

The drug should be used with caution in case of impaired liver or kidney function, in elderly patients, and in alcoholism.

The drug should not be used in patients with diarrhea.

Use during pregnancy and children

Children under 3 one month old suppositories are prescribed only on the recommendation of a doctor.

Contraindicated during breastfeeding.

Side effects

Possible nausea, epigastric pain, allergic reactions - skin rash, itching, urticaria, angioedema. In rare cases, dysfunction of the liver, kidneys, and hematopoietic system (anemia, agranulocytosis, thrombocytopenia) is observed. With long-term use in large doses - hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (interstitial nephritis, papillary necrosis). If side effects occur, you should stop taking the drug and consult your doctor.

Drug interactions

At simultaneous administration The patient taking other medications should consult a doctor.

Taken together with salicylates significantly increases the risk of nephrotoxicity.

When taking paracetamol and barbiturates, anticonvulsants (phenytoin), tricyclic antidepressants, rifampicin, butadione, and alcohol simultaneously, the risk of hepatotoxicity of the drug increases. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity.

Paracetamol enhances the effect of anticoagulants and reduces the effectiveness of uricosuric drugs.

When using the drug together with chloramphenicol, the toxicity of the latter increases.

Dosage

Dosage for adults:

The average single dose is 500 mg 2-4 times a day; maximum single dose - 1 g (2 suppositories of 500 mg each); maximum daily dose - 4 g.

The duration of treatment with paracetamol without consulting a doctor is 3-5 days.

Dosage for children:

Depends on the age and body weight of the child. The recommended single dose of paracetamol is 10-15 mg/kg of the child’s body weight. The drug is used 3-4 times a day with an interval of 4-6 hours. The maximum daily dose is no more than 60 mg/kg of the child’s body weight.

Overdose

Symptoms In case of overdose or hypersensitivity to the drug, pallor, lack of appetite, nausea, vomiting, and epigastric pain are noted. Increased levels of liver enzymes, increased prothrombin time, and later pain in the liver area. In severe cases, liver failure, hepatonecrosis, coma and encephalopathy.

Treatment. In these cases, it is recommended to lavage the stomach during the first four hours, take energy sorbents, intravenously administer the antidote - N-acetylcysteine, and administer methionine orally. If symptoms of poisoning appear, stop taking the drug and consult a doctor.

Precautions

When using the drug for more than 7 days, monitoring the functional state of the liver and the picture of peripheral blood is necessary.

If the patient's condition does not improve within 3-5 days, consult a doctor.

General characteristics. Compound:

Active substance: paracetamol - 0.5 g.
Excipients: potato starch, povidone, water-soluble methylcellulose, stearic acid.

Description: tablets white or off-white with a creamy tint, flat-cylindrical with a chamfer and a score.

Pharmacological properties:

Paracetamol is an analgesic and antipyretic. Blocks the synthesis of prostaglandins in the central nervous system due to inhibition of cyclooxygenase 1 and cyclooxygenase 2, affecting the centers of pain and thermoregulation. Does not exhibit anti-inflammatory effect. The lack of influence 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.

Indications for use:

Feverish syndrome in the background infectious diseases; (weak to moderate severity): , dental and .

Important! Get to know the treatment

Directions for use and dosage:

Adults, including the elderly and children over 12 years of age:
0.5-1 g, 1-2 hours after meals with plenty of liquid. Subsequent administration after 4-6 hours, maximum daily dose up to 4 g per day.

The interval between doses should be at least 4 hours. Do not take more than 8 tablets in 24 hours.

If symptoms persist, contact your doctor.

Features of application:

Before taking, consult your doctor if;
. You have serious illness liver or kidneys;
. You are taking anti-inflammatory drugs (metoclopramide, domperidone), as well as drugs that lower blood cholesterol (cholestyramine);
. You are taking anticoagulants and need painkillers daily and over a long period of time. In this case, paracetamol can be taken occasionally.

TO AVOID TOXIC DAMAGE TO THE LIVER, PARACETAMOL SHOULD NOT BE COMBINED WITH ALCOHOL BEVERAGES, AND SHOULD NOT BE TAKEN BY PERSONS PROMOTED TO CHRONIC ALCOHOL CONSUMPTION.

Side effects:

At recommended doses, the drug is usually well tolerated. Paracetamol rarely causes side effects. Sometimes allergic reactions (skin rash, itching, Quincke's edema), exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), nausea, epigastric pain may occur; , insomnia. With long-term use in large doses, the likelihood of dysfunction of the liver and kidneys, as well as the hematopoietic system, increases.

From the outside digestive system: nausea, epigastric pain, increased activity of liver enzymes, hepatonecrosis. From the outside endocrine system: .

If unusual symptoms occur, consult a doctor.

Contraindications:

Hypersensitivity to paracetamol or any other ingredient of the drug;
- severe liver or kidney dysfunction;
- childhood(up to 12 years old).

With caution:
Use with caution in benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholic liver damage, glucose-b-phosphate dehydrogenase deficiency, alcoholism, pregnancy, lactation, old age. The drug should not be taken simultaneously with other paracetamol-containing drugs.

Storage conditions:

Store in a dry place, protected from light and out of reach of children, at a temperature of 25 °C. Shelf life: 3 years. Do not use after the expiration date stated on the package.

Vacation conditions:

Over the counter

Package:

10 tablets of paracetamol 500 mg in blister or blister-free packaging.

Paracetamol -50 mg.

Release form

Suppositories, No. 10.

Pharmacological action

Analgesic-antipyretic.

Indications for use

Pain syndrome of mild to moderate intensity of various origins(incl. headache, migraine, toothache, neuralgia, myalgia, algodismenorrhea; pain from injuries, burns). Fever in infectious and inflammatory diseases.

Directions for use and doses

Rectally. Frequency of administration: 2-4 times a day; interval - at least 4 hours. The dose depends on the age and body weight of the child. The average single dose is 10-12 mg/kg body weight. The maximum daily dose of paracetamol should not exceed 60 mg/kg body weight. Depending on age, the following single doses are recommended:

• from 6 to 12 months – 0.5-1 suppository (50-100 mg);
• from 1 year to 3 years - 1-1.5 suppositories (100-150 mg);
• from 3 to 5 years – 1.5-2 suppositories (150-200 mg);
• from 5 to 10 years – 2.5-3.5 suppositories (250-350 mg);
• from 10 to 12 years – 3.5-5 suppositories (350-500 mg).

Do not take the drug for more than 3 days as an antipyretic and 5 days as an analgesic without a doctor’s prescription! In children under 3 months of age, it can be used when elevated temperature caused by vaccination. For all other indications, Paracetamol in children under 3 months of age is used only as prescribed by a doctor.

Contraindications

Chronic alcoholism, increased sensitivity to paracetamol.

Special instructions

Use with caution in patients with impaired liver and kidney function, with benign hyperbilirubinemia, as well as in elderly patients. With long-term use of paracetamol, monitoring of the peripheral blood picture and functional state liver. Used for the treatment of premenstrual tension syndrome in combination with pamabrom (a diuretic, a xanthine derivative) and mepiramine (a histamine H1 receptor blocker).

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 15°C. Shelf life: 2 years.

Note

The drug is approved for use as an over-the-counter product.

Paracetamol is a drug with analgesic and antipyretic effects.

Release form and composition

Paracetamol with the active substance of the same name is produced in the form:

• Tablets of 200 mg and 500 mg, 10 pcs. in blister packs;
• Syrup containing 125 mg of active substance per 5 ml, in dark glass bottles of 50 ml and 100 ml;
• Oral solution containing 200 mg of active substance per 5 ml, in dark glass bottles of 100 ml;
• Oral suspensions containing 120 mg of active substance per 5 ml, in dark glass bottles of 100 ml with a dosage spoon;
• Suppository for rectal use 50 mg, 100 mg, 250 mg, 500 mg, 10 pcs. in blister packs;
• Suppository for rectal use 100 mg for children, 5 pcs. in blister packs.

Indications for use

Paracetamol, according to the instructions, is prescribed for:

• Feverish syndrome due to infectious diseases;
• Moderate and mild pain syndrome caused by arthralgia, myalgia, neuralgia, migraine, algodismenorrhea, as well as toothache and headache.

Contraindications

The use of Paracetamol is contraindicated:

• In case of hypersensitivity to the components included in the drug;
• Children in the neonatal period (under 1 month).

The drug should be used with caution when:

• Alcoholic liver damage;
• Liver and kidney failure;
• Benign hyperbilirubinemia, including Gilbert's syndrome;
• Viral hepatitis;
• Alcoholism;
• Diabetes mellitus (for medicine in the form of syrup).

Also, Paracetamol, according to the instructions, is prescribed with caution to nursing and pregnant women, elderly people and children under 3 months.

Directions for use and dosage

A single dosage for adults and children over 12 years of age is 500 mg; according to indications, it can be increased to a maximum of 1 g. Frequency of use is up to 4 times a day.

Paracetamol is usually prescribed for children (daily dosage):

• Up to 7 kg (under 6 months) – 350 mg;
• Up to 10 kg (6-12 months) – 500 mg;
• Up to 15 kg (1-3 years) – 750 mg;
• Up to 22 kg (3-6 years) – 1 g;
• Up to 30 kg (6-9 years) – 1.5 g;
• Up to 40 kg (9-12 years) – 2 g.

The doctor calculates the dosage and frequency of use of Paracetamol in the form of suspension, syrup and oral solution individually based on age or weight.

The medicine can be taken as an antipyretic for 3 days, and as an analgesic for up to 5 days. Longer use of the drug is possible only after consulting a doctor.

Rectally Paracetamol is usually prescribed to adults 1-4 times a day, 500 mg (maximum 4 g per day).

The frequency of use and dosage of the drug in the form of suppositories for children is determined by age:

• 12-15 years – 3-4 times a day, 250-300 mg;
• 8-12 years – 3 times a day, 250-300 mg;
• 6-8 years – 2-3 times a day, 250-300 mg;
• 4-6 years – 3-4 times a day, 150 mg;
• 2-4 years – 2-3 times a day, 150 mg;
• 1-2 years – 3-4 times a day, 80 mg;
• 6-12 months – 2-3 times a day, 80 mg;
• 3-6 months – 2 times a day, 80 mg.

Side effects

As a rule, the use of Paracetamol leads to the development of side effects only in isolated cases. Most often they appear in the form allergic reactions: skin rash, itching, angioedema.

Also, during therapy, the development of hematopoietic disorders such as thrombocytopenia, anemia and methemoglobinemia is possible.

In case of overdose, Paracetamol, according to the instructions, on the first day can cause:

• Paleness of the skin;
• Anorexia;
• Nausea;
• Impaired glucose metabolism;
• Vomiting;
• Metabolic acidosis;
• Abdominal pain.

Liver dysfunction may occur 12-48 hours after an overdose.

After taking Paracetamol in very high doses, the following may develop:

• Pancreatitis;
• Liver failure accompanied by progressive encephalopathy;
• Arrhythmia;
• Acute renal failure with tubular necrosis.

In adults, the hepatotoxic effect usually occurs when taking more than 10 g of Paracetamol.

Special instructions

During the treatment period, it is not recommended to take ethanol, as it can lead to the development acute pancreatitis. Cancer risk bladder or kidneys increases with simultaneous long-term use of high doses of Paracetamol with salicylates. Myelotoxic medicines increase the manifestations of hematotoxicity of the drug.

During therapy, it should be taken into account that Paracetamol reduces the effectiveness of uricosuric drugs.

With long-term treatment, it is necessary to monitor the picture of peripheral blood and liver condition.

Analogs

Analogues of Paracetamol are:

• By active substance– Kalpol, Daleron, Prohodol, Efferalgan, Strimol, Apap, Efferalgan, Panadol, Ifimol;
• According to the mechanism of action - AntiFlu, Padevix, Novalgin, Prostudox, Maxicold, Caffetin, Coldfree, Gevadal, Rankof, Solpadeine, Flucoldex, Trigan-D, Rinikold, Prohodol, Dolaren, Antigrippin, GrippoFlu, Unispaz, No-spasma, Panadol, Flustop, No-shpalgin, Saridon, Fervex, AdzhiKOLD.

Terms and conditions of storage

The drug in any dosage forms released without a doctor's prescription. The shelf life of Paracetamol is:

• Suppositories – 2 years at temperatures up to 15 °C;
• Tablets – 3 years at temperatures up to 25 °C;
• Syrup, oral solution and suspension – 2 years at temperatures up to 25 °C.