Children's Panadol - instructions for use, dose, side effects, contraindications

Pharmacodynamics:The drug has analgesic and antipyretic properties. It blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation.

The anti-inflammatory effect is practically absent. Has no effect on the state of the mucosa of the gastrointestinal tract and water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics:Suction

Absorption is high. With rectal administration, the drug is rapidly and almost completely absorbed. The maximum concentration of the drug in the blood plasma is achieved 2-3 hours after the administration.

Distribution

The distribution of paracetamol in body fluids and tissues is relatively uniform.

Binding to plasma proteins is about 15%.

Metabolism

Metabolized mainly in the liver with the formation of several metabolites. In newborns and children under 12 years of age, the main metabolite of paracetamol is conjugated paracetamol sulfate. In children 12 years of age and older, the main metabolite of paracetamol is conjugated glucuronide. Part of the preparation (approximately 17%) undergoes hydroxylation with the formation of active metabolites, which are conjugated to glutathione. With a lack of glutathione, these metabolites of paracetamol can block the enzyme systems of hepatocytes and cause their necrosis.

Excretion

The half-life of plasma is 4-5 hours. The main amount of the drug is released after conjugation in the liver. It is mainly excreted by the kidneys. AT Within 24 hours, 90% of the dose of paracetamol is excreted in the urine. In an unchanged form, about 3% of the received dose of paracetamol is excreted.

Indications:

Applied in children from 6 months to 2.5 years (with a body weight of 8 to 12.5 kg) as:

- antipyretic agent to reduce the elevated body temperature in case of "colds", flu and children's infectious diseases (chicken pox, rubella, whooping cough, measles, scarlet fever, mumps and mumps) and gt;

- anesthetic for pain associated with teething, with toothache, earache with otitis and with sore throat. "Children's Panadol" is recommended to reduce high fever in children after vaccination.

Carefully:Use with caution in case of impaired liver or kidney function, with Gilbert syndrome. In the presence of any of the listed diseases before taking the drug should consult with a doctor.

Dosing and Administration:The drug is used rectally. Wash hands and release the suppository from the plastic sheath. Carefully insert the suppository with your index finger into the child's anus (preferably after a cleansing enema or spontaneous bowel movement).It will be easier to inject when the child's position is on the left side with one leg pulled up to the stomach.

Average single dose of the drug

"Children's Panadol" depends on the weight of the child and is 10-15 mg / kg of body weight 3-4 times a day every 4-6 hours. The maximum daily dose should not exceed 60 mg / kg of body weight.

Children with a body weight of 8 to 12.5 kg (usually from 6 months to 2.5 years) are administered 1 candle (125 mg) 3-4 times a day after 4-6 hours. Do not use more than 4 candles per day.

The duration of the application without a doctor's consultation is 3 days.

Do not exceed the recommended dose!

If the recommended dose is accidentally exceeded, the doctor should be consulted immediately, even if the child is feeling well, as there is a risk of developing liver damage (see. "Overdose").

If the child's condition does not improve when taking the drug, consult your doctor.

Side effects:

In recommended doses, the drug is usually well tolerated. The following side effects were revealed spontaneously during the post-marketing use of the drug.

Side effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10),infrequently (greater than or equal to 1/1000 and less than 1/100), rarely (greater than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less than 1/10 000).

Allergic reactions:

Very rarely - in the form of rashes on the skin, itching, hives, angioedema, Stevens-Johnson syndrome, anaphylaxis;

From the side hematopoiesis system:

Very rarely - thrombocytopenia, anemia, leukopenia;

From the respiratory system:

Very rarely - bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs);

From the hepatobiliary system:

Very rarely - a violation of the liver.

Sometimes nausea and vomiting are possible.

If any of these side effects occur, stop taking the medication and consult a doctor immediately.

Overdose:Symptoms: during the first 24 hours after an overdose - nausea, vomiting, stomach pain, sweating, pale skin, anorexia. After 1-2 days, signs of liver damage are determined (soreness in the liver, increased activity of "liver" enzymes). maybe development of a violation of carbohydrate metabolism and metabolic acidosis. In adult patients, liver damage develops after taking more than 10 g of paracetamol, in children - when taking more than 125 mg / kg of the body weight of the child. In the presence of factors that affect the toxicity of paracetamol for the liver, (see. section "Interaction with other medicines", "Special instructions"), liver damage is possible after taking 5 or more grams of paracetamol.

In severe cases of overdose, as a result of liver failure, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema can occur, up to a lethal outcome. It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (an admixture of blood or erythrocytes in the urine), proteinuria (increased protein content in the urine), with severe liver damage may be absent. There were cases of heart rhythm disturbances, pancreatitis.

With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) can be observed. Treatment: If you suspect an overdose, even if the first symptoms are not pronounced, stop using the drug and seek medical help immediately. When an overdose caused by the introduction of paracetamol rectally, gastric lavage and the reception of enterosorbents are ineffective. It is necessary to determine the level of paracetamol in the blood plasma, but not earlier than 4 hours after an overdose (earlier results are not reliable). Introduction of acetylcysteine within 24 hours after an overdose. The maximum protective effect is achieved within the first 8 hours after an overdose, with time the effectiveness of the antidote drops sharply. If necessary, enter acetylcysteine intravenously. If there is no vomiting before the patient enters the hospital, methionine may be used. The need for additional therapeutic measures (further introduction of methionine, iv injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction withspecialists of the toxicological center or specialized department of liver diseases.

Interaction:

If the child is already taking other medications, before taking the drug "Children's Panadol" should consult a doctor.

Barbiturates, carbamazepine, phenytoin, difenine, primidon and other anticonvulsants, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, butadione, preparations St. John's Wort perforated and others inducers microsomal oxidation increase the production of hydroxylated active metabolites, conditioning possibility of development heavy liver damage with small overdoses of paracetamol (5 g or more).

Inhibitors microsomal liver enzymes reduce the risk of hepatotoxic effects.

Under the influence of paracetamol, the time for removal of levomycetin (chloramphenicol) increases in 5 times, resulting in increased risk of poisoning with levomycetin (chloramphenicol).

With regular intake for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants. Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs.

Special instructions:"Children's Panadol" rectal suppositories are indicated for children who hardly take tablets or are prone to vomiting.

When conducting tests for the determination of uric acid and blood sugar, tell your doctor about the use of the drug "Children's Panadol".

When taking the drug for more than 7 days, monitoring is recommended peripheral blood and the functional state of the liver. Deficiency of glutathione due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more).

The drug should not be used concurrently with other paracetamol-containing drugs.

Form release / dosage:Suppositories rectal, 125 mg.

Packaging:For 5 or 10 suppositories in a contoured cell package (strip) made of polyvinyl chloride and polyethylene.1 or 2 strips together with instructions for use are placed in a cardboard box.

Shelf life:5 years.

Terms of leave from pharmacies:On prescription

Registration number:П N011292 / 02

Date of registration:09.04.2010 / 18.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

FARMACLAIR France

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Children's Panadol (Panadol Baby)