Children's Panadol (Oral suspension)

Active material: Paracetamol
When ATH: N02BE01
CCF: Analgesic-antipyretic
ICD-10 codes (testimony): A38, B01, B05, H92.0, J06.9, J10, K00.7, K08.8, R07, R50, R51
When CSF: 03.02.01.01
Manufacturer: GlaxoSmithKline Consumer Healthcare (Great Britain)

Pharmaceutical form, composition and packaging

Oral suspension Pink colour, viscous, Crystals and strawberry scent.

5 ml
paracetamol120 mg

Excipients: malic acid, Xanthan Gum, maltitol (hydrogenates glucose syrup), sorbitol, lemon acid, nipasept sodium, strawberry flavor, azoruʙin, water.

100 ml – vials of dark glass (1) complete with a measured syringe – cardboard boxes.
300 ml – vials of dark glass (1) complete with a measured syringe – cardboard boxes.
1000 ml – vials of dark glass (1) – cardboard boxes.

 

Pharmacological action

Analgesic-antipyretic. It has analgesic and antipyretic effect. Blocking cyclooxygenase in the CNS, acting on pain centers and thermoregulation.

Anti-inflammatory effect is practically absent.

It has no effect on the state of the gastrointestinal mucosa and water-salt metabolism, since no effect on prostaglandin synthesis in peripheral tissues.

 

Pharmacokinetics

Absorption and distribution

Absorption vыsokaya. Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax plasma achieved through 30-60 m.

Communication with the plasma proteins around 15%. Distribution of paracetamol in body fluids is relatively evenly.

Metabolism

It is metabolized primarily in the liver with the formation of several metabolites. In newborns the first two days of life and in children 3-10 years is a major metabolite of paracetamol paracetamol sulphate, children 12 and older – conjugated glucuronide.

Part of the preparation (about 17%) undergoes hydroxylation to form active metabolites, which is conjugated with glutathione. With a lack of glutathione, these metabolites paracetamol can block the enzyme systems of hepatocytes and cause their death.

Deduction

T1/2 upon receipt of the therapeutic dose is from 2-3 no. When receiving therapeutic doses 90-100% highest dose excreted in urine within one day. The basic amount of the drug released after conjugation in the liver. In unaltered stands no more 3% received a dose of paracetamol.

 

Testimony

Applied in children between the ages of 3 Months before 12 years:

- For reducing elevated body temperature on the background colds, flu and childhood infectious diseases (incl. enable vetryanaya, Mumps, kor, rubella, scarlet fever);

- Toothache (incl. teething), headache, otitis Ear pain and sore throat.

Children 2-3 months of life possible single dose to reduce the temperature of the body after vaccination.

 

Dosage regimen

The drug is taken orally. Before use, the contents of the vial should be shaken well. Measuring syringe, nested inside the package, It allows you to properly and efficiently dispense the drug.

The dose depends on the age and weight of the child.

Children over 3 Months the drug is prescribed for 5 mg / kg body weight 3-4 times / day, The maximum daily dose is not more than 60 mg / kg body weight. If necessary, you can take the drug every 4-6 hours in a single dose (5 mg / kg), but not more 4 times during 24 no.

Body Weight (kg)AgeSingle doseThe maximum daily dose
mlmgmlmg
4,5-62-3 MonthsOnly on medical prescription
6-83- 6 Months4.09616384
8-106-12 Months5.012020480
10-131-2 year7.016828672
13-152-3 year9.021636864
15-213-6 years10.024040960
21-296-9 years14.0336561344
29-429-12 years20.0480801920

Do not exceed the recommended dose.

The duration of the reception without consulting a doctor: to reduce the temperature – no more 3 days, to reduce pain – no more 5 days.

Further, as well as the absence of a therapeutic effect is necessary to consult a doctor.

 

Side effect

From the digestive system: sometimes – nausea, vomiting, pain in the stomach

Allergic reactions: sometimes – skin rash, itch, hives, angioedema.

From the hematopoietic system: rarely – anemia, thrombocytopenia, leukopenia.

When taken in recommended doses, acetaminophen rarely has side effects. When side effects, stop taking the drug and consult a doctor.

 

Contraindications

- Expressed human liver or kidney problems;

- The neonatal period;

- Hypersensitivity to paracetamol or any other component of the drug.

FROM caution use in patients with hepatic dysfunction (incl. Gilbert's syndrome), renal impairment, genetic absence of the enzyme glucose-6-phosphate dehydrogenase, severe blood diseases (severe anemia, leukopenia, thrombocytopenia).

The drug should not be taken simultaneously with other acetaminophen-containing medications.

 

Cautions

Children from 2 to 3 months and children, born preterm, Children's Panadol may be given only on prescription.

When conducting tests to determine the levels of uric acid and glucose levels in the blood serum of the physician should be aware of the use of the drug by the patient Children's Panadol.

Before the drug more 7 days recommended monitoring of peripheral blood and functional state of the liver.

 

Overdose

Symptoms acute paracetamol poisoning: nausea, vomiting, stomachache, Sweating, pale skin. Through 1-2 days defined signs of liver damage (pain in the liver, increase in liver enzymes). In severe cases develop liver failure, encephalopathy and coma.

Prolonged use in excess of the recommended dose can be observed hepatotoxicity and nephrotoxicity (počečnaâ how, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).

Treatment: stop taking the drug and seek immediate medical attention. It is recommended gastric lavage and receiving enterosorbents (Activated carbon, Polyphepanum). A specific antidote for acetaminophen poisoning is NAC.

In case of accidental overdose, seek immediate medical attention, even if the child feels good.

 

Drug Interactions

If you use the Children's Panadol along with barbiturates, difeninom, anticonvulsants, rifampicin, butadionom possible increased risk of hepatotoxicity.

When concomitantly with chloramphenicol (chloramphenicol) may increase the toxicity of the latter.

The anticoagulant effect of warfarin and other coumarin derivatives can be amplified against the backdrop of a long regular intake of paracetamol, which increases the risk of bleeding.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature not exceeding 30 ° C. Do not freeze. Shelf life – 3 year.

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