Paracetamol children's suspension. for oral administration (orange) 120mg / 5ml fl. 200g

Dosage form

Homogeneous suspension for oral administration for children 2.4% suspension from light gray or light gray with a yellowish tinge to gray or gray with a yellowish tinge with a characteristic fruity odor.

Structure

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 flavor or strawberry flavor - 6.5 mg, water (purified water) - up to 5 ml.

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 μg / 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. 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 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 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 hydroxidation 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 infants) 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.

Indications

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

Contraindications

- individual hypersensitivity to drug components

- diseases of the blood system

- genetic absence of glucose-6-phosphate dehydrogenase

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

- neonatal period (age up to 1 month).

Application during pregnancy and lactation

Paracetamol crosses the placental barrier.

To date, no negative effects of paracetamol on the fetus in humans have been noted.

Paracetamol is excreted in breast milk: the content in milk is 0.04-0.23% of the dose taken by the mother.

If it is necessary to use paracetamol during pregnancy and lactation (breastfeeding), the expected benefit should be carefully weighed

Name ENG

PARACETAMOL

Clinical and pharmacological group

Analgesic antipyretic

ATX code

Paracetamol

Dosage

120mg / 5ml x 200g

Structure

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 flavor or strawberry flavor - 6.5 mg, water (purified water) - up to 5 ml.

Indications

Pain syndrome of weak and moderate intensity of various origins (including headache, migraine, toothache, neuralgia, myalgia, algodismenorrhea pain with injuries, burns). Increased body temperature with colds and other infectious and inflammatory diseases.

Storage conditions and periods

At a temperature not exceeding 25 degrees (do not freeze).

Expiration date: 3 years

after opening - 6 months

Contraindications

Hypersensitivity to paracetamol.

Severe liver or kidney dysfunction.

Genetic absence of glucose-6-phosphate dehydrogenase.

Diseases of the blood.

Undesirable use during pregnancy and lactation.

With caution in Gilbert's syndrome (constitutional hyperbilirubinemia).

Chronic active alcoholism.

INN / Active ingredient

paracetamol

Specifications

Category

Pain and fever

Scope of the drug

General

Release form

Oral suspension

Manufacturer country

Russia

Package quantity, pcs

one

Minimum age from

1 month

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Pharmstandard

Components

dosing device

The amount of the dosage form in the primary package

200 g

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Analgesic non-narcotic drug

Anatomical and therapeutic characteristics

N02BE01 Paracetamol

Dosage form

Oral suspension, [orange]

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

paracetamol 120 mg

Package weight, g

200

Mode of application

:

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. < br> The drug is taken orally before meals undiluted with plenty of liquid. Shake well before use. Frequency of admission no more than 4 times a day with an interval of at least 4 hours. < br> 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. < br> For accurate dosage of the drug, depending on the proposed configuration, use a measuring spoon or a measuring syringe enclosed in the package. < br> If using a measuring syringe: < br> 1. Shake the suspension thoroughly. < br> 2.Open the bottle cap. < br> 3. Firmly insert the measuring syringe into the hole of the adapter installed in the neck of the bottle. < br> 4. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the measuring syringe to the desired mark. < br> 5. Return the bottle to its original position and remove the measuring syringe by gently turning it. < br> 6. Give the drug to the child inside with a measuring syringe. To ensure a smooth flow of the suspension into the oral cavity, slowly press the plunger. < br> After each use, rinse the measuring syringe in running water and dry disassembled at room temperature out of the reach of the child. < br> Store the measuring syringe in the package together with the preparation. < br> Depending on the age, Paracetamol for children" is prescribed in the following single doses: < br> - 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 repeated dose, consult a doctor. 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 doctor. If it is necessary to use the drug for a premature baby aged 1-3 months, the drug is prescribed only on the recommendation of a doctor. < br> - from 3 months to 1 year - 2.5-5 ml or 60-120 mg of paracetamol, depending on the child's body weight (see table below) < br> - from 1 year to 6 years - 5-10 ml or 120-240 mg, depending on the child's body weight (see the table below) < br> - from 6 to 14 years old - 10-20 ml or 240-480 mg, depending on the child's body weight (see table below) < br> Child's body weight Single dose of the drug < br> 4-8 kg 2.5 ml < br> 8-16 kg 5 ml < br> 16-32 kg 10 ml < br> more than 32 kg 15-20 ml < br > - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.- from 1 year to 6 years - 5-10 ml or 120-240 mg, depending on the child's body weight (see table below) < br> - from 6 to 14 years old - 10-20 ml or 240-480 mg, depending on the child's body weight (see table below) < br> Body weight of the child Single dose of the drug < br> 4-8 kg 2.5 ml < br> 8-16 kg 5 ml < br> 16-32 kg 10 ml < br> more than 32 kg 15-20 ml < br > - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.- from 1 year to 6 years - 5-10 ml or 120-240 mg, depending on the child's body weight (see table below) < br> - from 6 to 14 years old - 10-20 ml or 240-480 mg, depending on the child's body weight (see table below) < br> Child's body weight Single dose of the drug < br> 4-8 kg 2.5 ml < br> 8-16 kg 5 ml < br> 16-32 kg 10 ml < br> more than 32 kg 15-20 ml < br > - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.- from 6 to 14 years old - 10-20 ml or 240-480 mg, depending on the child's body weight (see table below) < br> Body weight of the child Single dose of the drug < br> 4-8 kg 2.5 ml < br> 8-16 kg 5 ml < br> 16-32 kg 10 ml < br> more than 32 kg 15-20 ml < br > - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.- from 6 to 14 years old - 10-20 ml or 240-480 mg, depending on the child's body weight (see table below) < br> Body weight of the child Single dose of the drug < br> 4-8 kg 2.5 ml < br> 8-16 kg 5 ml < br> 16-32 kg 10 ml < br> more than 32 kg 15-20 ml < br > - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.more than 32 kg 15-20 ml < br> - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.more than 32 kg 15-20 ml < br> - for adults - a single dose of 20 ml no more than 4 times a day. < br> Duration of treatment is not more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor !!! < br> Do not exceed the prescribed dose! An overdose of paracetamol can cause liver failure.

Information on technical characteristics, delivery set, country of manufacture "