Panadol baby 120 mg/5 ml 100 ml suspension. for oral administration for children.
Instructions for medical use of the drug CHILDREN'S PANADOL® Trade name Children's Panadol® International nonproprietary name Paracetamol Dosage form Oral suspension for children 120 mg/5 ml Composition 5 ml of suspension contain the active substance - paracetamol 120 mg, excipients: malic acid, xanthan gum, Maltitol liquid, strawberry flavor L 10055, sorbitol 70% (crystallized), sodium nipasept, anhydrous citric acid, sorbitol, purified water. Description Colorless viscous suspension with strawberry odor. The suspension may contain small white crystals. Pharmacotherapeutic group: Other analgesics-antipyretics. Anilides. Paracetamol. ATC code N02BE01 Pharmacological properties Pharmacokinetics Absorption is high. Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract. Communication with blood plasma proteins is about 15%. Peak plasma concentrations are reached after 30–60 minutes. The distribution of paracetamol in body fluids is relatively uniform. Metabolized primarily in the liver with the formation of several metabolites. 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. Part of the drug (approximately 17%) undergoes hydroxylation to form active metabolites that are conjugated with glutathione. With a lack of glutathione, these metabolites of paracetamol can block the enzyme systems of hepatocytes and cause their necrosis. The half-life when taking a therapeutic dose is 2-3 hours. When taking therapeutic doses, 90-100% of the dose taken is excreted in the urine within one day. The main amount of the drug is released after conjugation in the liver. No more than 3% of the received dose of paracetamol is excreted unchanged. Pharmacodynamics The drug has analgesic and antipyretic properties. Blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. The antipyretic effect is associated with a violation of the synthesis of prostaglandins and a decrease in their pyrogenic effect on the thermoregulation center located in the hypothalamus. A decrease in body temperature occurs due to heat transfer; with normothermia, body temperature does not change, since paracetamol is a non-selective cyclooxygenase inhibitor. The anti-inflammatory effect is practically absent. It does not affect the condition of the gastrointestinal mucosa and water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues. Indications for use - as an antipyretic for colds, flu, childhood infectious diseases (chicken pox, rubella, whooping cough, measles, scarlet fever and mumps) - as an analgesic for teething, toothache, ear pain with otitis media, sore throat, headache. Used in children from 3 months to 12 years. Can be used in children from 2 to 3 months only as prescribed by a doctor. A single dose is possible to reduce fever after vaccination. If the temperature does not decrease, consult a doctor. Method of administration and dosage The drug is taken orally. The contents of the bottle should be shaken well before use. The measuring syringe placed inside the package allows you to dose the drug correctly and rationally. The dose of the drug depends on the age and body weight of the child. For children over 3 months of age, a single dose is 10-15 mg/kg body weight, 3-4 times a day, the maximum daily dose is no more than 60 mg/kg body weight. If necessary, give your child the recommended dose every 4 to 6 hours, but no more than 4 doses in 24 hours. In all other cases, before taking Children's Panadol®, you must consult a doctor. Body weight (kg) Age Dose Single Maximum daily ml mg ml mg 4.5 - 6 2-3 months Only by doctor's prescription 6 - 8 3- 6 months 4.0 96 16 384 8-10 6-12 months 5.0 120 20 480 10- 13 1-2 years 7.0 168 28 672 13-15 2-3 years 9.0 216 36 864 15-21 3-6 years 10.0 240 40 960 21-29 6-9 years 14.0 336 56 1344 29-42 9-12 years 20.0 480 80 1920 It is not recommended to take the drug for more than 3 days without a doctor’s prescription and supervision. Side effects Very rarely - nausea, vomiting, pain in the stomach - allergic reactions (skin rash, itching, urticaria, Quincke's edema, anaphylaxis, Stevens-Johnson syndrome) - anemia, thrombocytopenia, leukopenia, agranulocytosis With long-term use exceeding the recommended dose, it may hepatotoxic and nephrotoxic effects are observed. In patients with hypersensitivity to acetylsalicylic acid and other NSAIDs, bronchospasm is possible. You should stop taking the drug and consult a doctor immediately if the above reactions occur, as well as peeling, mouth ulcers, difficulty breathing, bruises, bleeding or any other undesirable reaction to the drug. Contraindications - hypersensitivity to paracetamol or any other ingredient of the drug - severe impairment of liver or kidney function - genetic absence of the enzyme glucose-6-phosphate dehydrogenase - severe blood diseases (severe anemia, leukopenia, thrombocytopenia) - hereditary fructose intolerance - children under 2 months of age Medicinal interactions When using Children's Panadol® together with barbiturates, diphenine, anticonvulsants, rifampicin, butadione, the risk of hepatotoxicity may increase. When taken simultaneously with chloramphenicol (chloramphenicol), the toxicity of the latter may increase. The anticoagulant effect of warfarin and other coumarin derivatives may be enhanced by long-term regular use of paracetamol, which increases the risk of bleeding. Special instructions For children from 2 to 3 months and children born prematurely, Children's Panadol® can only be given as prescribed by a doctor. When performing tests to determine uric acid and blood sugar levels, tell your doctor about the use of Children's Panadol®. When taking the drug for more than 7 days, it is recommended to monitor peripheral blood parameters and the functional state of the liver. The drug contains 666.5 mg of sorbitol (E 420) in 5 ml of suspension. Sodium methyl ethyl and propyl parahydroxybenzoates (E219, E215, E217 - sodium nipasept) can cause delayed allergic reactions. Use with caution in case of impaired liver function (including Gilbert's syndrome) and kidneys. The use of paracetamol in conditions that reduce glutathione levels (for example, sepsis) increases the risk of metabolic acidosis. If a combination of the following symptoms appears: - deep, rapid, labored breathing - feeling unwell (nausea, vomiting) - loss of appetite, you should consult a doctor. The drug should not be taken simultaneously with other paracetamol-containing drugs. If symptoms persist, you should consult a doctor. Overdose Symptoms: nausea, vomiting, stomach pain, sweating, pale skin. After 1-2 days, signs of liver damage are determined (pain in the liver area, increased activity of liver enzymes). In severe cases, liver failure, encephalopathy and coma develop. With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) may be observed. Treatment: Stop using the drug and consult a doctor immediately. It is recommended to lavage the stomach and take enterosorbents (activated carbon, polyphepan). It is possible to use N-acetylcysteine and methionine. In case of accidental overdose, seek immediate medical attention, even if the child feels well. Release form and packaging 100 ml of suspension in dark glass bottles, sealed with a polypropylene screw cap with first opening control. A label is placed on the bottle. 1 bottle, along with a measuring syringe and instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 30°C. Do not freeze! Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date stated on the package. Conditions for dispensing from pharmacies Without a prescription
Panadol Tablets, pack, 12 pcs, 500 mg, soluble, for body, effervescent
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 (pain in the liver area, increased activity of “liver” enzymes). The development of carbohydrate metabolism disorders and metabolic acidosis is possible. In adult patients, liver damage develops after taking more than 10 g of paracetamol.
If there are factors that influence the toxicity of paracetamol to the liver (see section “Interaction with other drugs”, “Special instructions”), liver damage is possible after taking 5 or more grams of paracetamol. In severe cases of overdose, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema, and even death may develop as a result of liver failure.
It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (admixture of blood or red blood cells in the urine), proteinuria (increased protein in the urine), while severe liver damage may be absent. There have been cases of heart rhythm disturbances and pancreatitis.
Treatment:
If an overdose is suspected, even in the absence of pronounced first symptoms, it is necessary to stop using the drug and immediately seek medical help. Within 1 hour after an overdose, it is recommended to lavage the stomach and take enterosorbents (activated carbon, polyphepan). The level of paracetamol in the blood plasma should be determined, but not earlier than 4 hours after the overdose (earlier results are unreliable). Administration of acetylcysteine within 24 hours of an overdose.
The maximum protective effect is provided during the first 8 hours after an overdose; over time, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine is administered intravenously. In the absence of vomiting, methionine can be used before the patient is admitted to the hospital. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.
Panadol Baby
An overdose of paracetamol can cause liver failure, which may lead to the need for a liver transplant or death. Acute pancreatitis was observed, accompanied by liver dysfunction and hepatotoxicity.
In the event of an overdose of Children's Panadol, even if the patient feels well and there are no significant symptoms of overdose, it is necessary to stop using the drug and immediately consult a doctor for medical assistance.
Symptoms and signs
The hepatotoxic effect in adults occurs when taking paracetamol in an amount of 10 g or more, in children - when taking more than 125 mg/kg of the child’s body weight. If there are factors that influence the toxicity of paracetamol to the liver (see sections “Interaction with other drugs”, “Special instructions”), liver damage may occur after taking paracetamol in an amount of 5 g or more.
With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) may be observed.
During the first 24 hours after an overdose, the following symptoms may appear: nausea, vomiting, stomach pain, impaired glucose metabolism (sweating, dizziness, loss of consciousness), pale skin, decreased appetite, impaired carbohydrate metabolism. Clinical signs of liver damage usually develop after 24-18 hours and reach a maximum after 4-6 days. Signs of impaired glucose metabolism and metabolic acidosis may occur.
In severe cases of overdose, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema, and even death may develop as a result of liver failure. It is also possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (admixture of blood or red blood cells in the urine), proteinuria (increased protein in the urine), while severe liver damage may be absent. There have been cases of heart rhythm disturbances and pancreatitis.
Treatment
If you suspect an overdose of Children's Panadol, even in the absence of pronounced first symptoms, you must stop using the drug and immediately consult a doctor for medical assistance. During the first hour after an overdose, it is recommended to take enterosorbents (activated carbon, polyphepane). The level of paracetamol in the blood plasma should be determined, but not earlier than 4 hours after an overdose (earlier results are unreliable).
There is no convincing evidence that gastric lavage beyond 60 minutes after overdose improves clinical outcome.
Administration of acetylcysteine within 24 hours after an overdose. The maximum protective effect is ensured during the first 8 hours after an overdose; over time, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine is administered intravenously. In the absence of vomiting, methionine can be used before the patient is admitted to the hospital.
The need for additional therapeutic measures (use of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.
