Antiflu Kids powder for oral solution 12 g in bags of 5 pcs.

Pharmacodynamics. Acetaminophen (paracetamol) has analgesic, antipyretic and weak anti-inflammatory effects. Its mechanism of action is to inhibit prostaglandin synthesis and affect the thermoregulation center in the hypothalamus.

Ascorbic acid (vitamin C) as a key component of the antioxidant and immune defense system increases the body’s adaptive capabilities, increases its resistance to infections. Takes an active part in the regulation of redox processes, in carbohydrate metabolism, synthesis of steroid hormones, catecholamines and blood clotting. Enhances collagen synthesis, stimulates regeneration processes, normalizes capillary permeability.

Chlorpheniramine maleate is an antihistamine of the alkylamine class, a blocker of H ₁ -histamine receptors. It has an antiallergic effect, eliminates rhinorrhea, lacrimation and itching in the eyes and nose. The therapeutic effect develops within 1 hour after oral administration and lasts for 24 hours.

The components of the drug are metabolized independently of each other.

Pharmacokinetics. After oral administration, acetaminophen is rapidly absorbed, mainly in the upper digestive tract. It is rapidly distributed in tissues. Binding to blood proteins is 10%. Acetaminophen is metabolized in the liver: most of it is bound to glucuronic acid, less to sulfuric acid. The half-life of acetaminophen is 2-2.5 hours. It increases in individuals with liver disease.

Paracetamol is excreted in the urine (85% of a single dose of paracetamol is excreted within 24 hours). Excretion is significantly impaired in cases of impaired renal excretory function, which can lead to the accumulation of acetaminophen and its metabolic products in the body. Ascorbic acid is actively absorbed in the small intestine. After oral administration, C _max in blood plasma is reached after 4 hours. From blood plasma, it easily penetrates into leukocytes, platelets and almost all tissues. It undergoes biotransformation in the liver, is excreted in the urine partly in unchanged form, partly in the form of metabolites.

Chlorpheniramine maleate is metabolized in the liver. T _½ is 8 hours. Chlorpheniramine maleate and its metabolites are excreted in the urine.

Prescribed for children aged 2 to 12 years for influenza, acute respiratory viral infections and colds to reduce body temperature, eliminate headache, muscle and joint pain, rhinorrhea, sneezing, tearing and other symptoms of inflammation of the mucous membrane of the upper respiratory tract and paranasal sinuses.

Inside, regardless of meals, having previously dissolved the contents of the packet in a glass of hot (not boiling) water. The recommended amount of water for dissolving the powder is usually the volume that the child drinks in one dose (100-200 ml). A single dose for children aged 2-5 years is the contents of 1 packet, for children 6-12 years – 2 packets. If necessary, repeat the dose every 4-6 hours, but no more than 4 packets during the day. The maximum period of use without consulting a doctor is 3 days. Further use is possible only under the supervision of a doctor.

Children: Do not use in children under 2 years of age. Consult a doctor before using the drug in children aged 2-5 years.

The maximum dose for children is up to 100 mg/kg/day, or 4000 mg/day.

Hypersensitivity to the components of the drug or other antihistamines; severe liver dysfunction (9 points on the Child-Pugh scale) and / or kidneys, alcoholism, congenital deficiency of glucose-6-phosphate dehydrogenase; congenital hyperbilirubinemia (including Gilbert’s syndrome); hematopoietic disorders, blood diseases, severe leukopenia, anemia, tendency to thrombosis; severe cardiac conduction disorders, decompensated heart failure, bladder neck obstruction, pyloroduodenal obstruction; thrombosis, thrombophlebitis; severe forms of diabetes mellitus, angle-closure glaucoma; gastric ulcer and duodenal ulcer in the acute stage; children’s age up to 2 years.

Do not use simultaneously with MAO inhibitors and within 2 weeks after discontinuation of MAO inhibitors.

MAO inhibitors should not be used with antihistamines due to the potential for additive CNS depression. They may prolong and potentiate the anticholinergic effects of antihistamines.

In most cases, the drug is well tolerated.

The following side effects may occur:

• from the blood system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia (if the patient has glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia, thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, agranulocytosis, thrombocytopenic purpura, leukopenia, hematomas or bleeding;
• Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• from the digestive tract: heartburn, nausea, vomiting, dry mouth, discomfort and pain in the epigastric region, hypersalivation, decreased appetite, constipation, diarrhea, flatulence;
• from the endocrine system: hypoglycemia up to hypoglycemic coma, damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the onset of diabetes mellitus;
• Liver: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect);
• Immune system disorders: hypersensitivity reactions (including allergic reactions), anaphylactic reactions and anaphylactic shock;
• from the nervous system: headache, dizziness, psychomotor agitation and disorientation, anxiety, feeling of fear, sleep disturbances, drowsiness, insomnia, confusion, coma, convulsions, dyskinesia, behavioral changes;
• from the cardiovascular system: tachycardia, reflex bradycardia, shortness of breath, heart pain, increased blood pressure, arrhythmia, myocardial dystrophy (dose-dependent effect with prolonged use);
• from the urinary system: renal colic and interstitial nephritis, urinary retention and difficulty urinating, aseptic pyuria, with prolonged use in high doses – damage to the glomerular apparatus of the kidneys, crystalluria, formation of urate, cystine and / or oxalate stones in the kidneys and urinary tract;
• on the part of the organs of vision: accommodation disorders, dry eyes, mydriasis, visual impairment, increased intraocular pressure;
• Metabolic: zinc and copper metabolism disorders, hypokalemia;
• Skin and subcutaneous tissue disorders: itching, skin and mucous membrane rashes (usually generalized rash, erythema, urticaria), allergic and angioedema, acute generalized exanthematous pustulosis, local drug dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), including fatal outcome.

Concomitant use with other drugs intended for the symptomatic treatment of colds and flu, drugs containing paracetamol should be avoided. Do not exceed the recommended dose and duration of treatment. Concomitant use with other drugs containing paracetamol may lead to overdose. Paracetamol overdose may cause liver failure, which may require liver transplantation or be fatal.

Patients with low glutathione levels, such as those with severe infections such as sepsis, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, and loss of appetite. You should seek medical attention immediately if you experience these symptoms.

If symptoms persist, you should consult a doctor.

Prolonged use of high doses may lead to liver and kidney damage; a large number of concomitant medications, alcoholism, alcoholic liver disease, sepsis, or diabetes mellitus may increase the risk of hepatotoxicity of paracetamol (acetaminophen) at therapeutic doses.

It should be taken into account that patients with liver diseases have an increased risk of hepatotoxic effects of paracetamol. It is necessary to consult a doctor about the possibility of using the drug in patients with mild and moderate renal and hepatic impairment.

This medicine is not recommended for use simultaneously with sedatives or hypnotics.

Before using the drug, it is necessary to consult a doctor if the patient is using warfarin or similar drugs that have an anticoagulant effect.

Paracetamol may affect the results of laboratory tests for blood glucose and uric acid levels.

The drug should be prescribed by a doctor only after assessing the risk/benefit ratio in the following cases: severe hypertension, epilepsy, glaucoma, oxaluria, urinary disorders, urinary retention, prostate enlargement, asthma, bronchitis, thyrotoxicosis, glutathione deficiency.

The recommended dose and duration of treatment should not be exceeded. If, on the recommendation of a doctor, the drug is used for a long period, it is necessary to monitor the functional state of the liver and the picture of peripheral blood.

Severe skin reactions have been reported very rarely. If you experience redness, rash, blistering or peeling of the skin, stop using paracetamol and seek medical attention immediately.

1 packet (1 dose) contains 11.6 g of sugar, which should be taken into account by diabetics and patients on a low-sugar diet. Use with caution in diabetics. Simultaneous administration of the drug with alkaline drinks reduces the absorption of ascorbic acid, so you should not wash down the powder with alkaline mineral water. Also, the absorption of ascorbic acid may be impaired in intestinal dyskinesias, enteritis and achilia.

This medicine should not be taken by people with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency due to the sucrose content. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

In case of high body temperature or prolonged fever that persists for 3 days while using the drug, or if signs of superinfection appear, you should consult a doctor.

Ascorbic acid may alter the results of laboratory tests (glucose, blood bilirubin, transaminase activity).

Do not take the drug with other remedies for the symptomatic treatment of colds and flu that contain paracetamol or antihistamines. If symptoms persist, you should consult a doctor. If the headache becomes persistent, you should also consult a doctor.

Chlorpheniramine may mask the symptoms of hypersensitivity reactions and affect the results of skin tests. Therefore, the drug should be discontinued several days before these procedures.

Use during pregnancy and breastfeeding. Do not use.

Ability to influence the reaction rate when driving or operating other mechanisms. Due to the likelihood of drowsiness after using chlorpheniramine maleate, children should be kept from activities requiring increased concentration of attention for 4 hours after taking the drug.

When used simultaneously with acetaminophen, the following types of interactions are possible:

• slowing down the elimination of antibiotics from the body;
• anticonvulsants (including phenytoin, barbiturates, carbamazepine), rifampicin, and alcohol enhance the hepato- and nephrotoxicity of acetaminophen;
• barbiturates reduce the antipyretic effect of acetaminophen;
• Tetracycline increases the risk of developing anemia and methemoglobinemia caused by acetaminophen;
• When paracetamol is used simultaneously with hepatotoxic drugs, the toxic effect of the drugs on the liver increases; do not use simultaneously with alcohol;
• acetaminophen reduces the effectiveness of diuretics;
• simultaneous use of high doses of acetaminophen with isoniazid or rifampicin increases the risk of developing hepatotoxic syndrome;
• increased effect of indirect anticoagulants with an increased risk of bleeding;
• the rate of absorption of acetaminophen is increased by metoclopramide and domperidone and decreased by cholestyramine;
• with simultaneous long-term use with coumarin derivatives (e.g. warfarin) may enhance their effect with an increased risk of bleeding; patients taking oral anticoagulants should consult a doctor, blood clotting parameters should be monitored;
• taking paracetamol (acetaminophen) may affect the results of blood glucose determination using the glucose oxidase-peroxidase method with abnormally high concentrations;
• taking paracetamol may affect the results of determining the level of urea in the blood using the phosphotungstic acid method;
• Tropisetron and granisetron, type 3 5-hydroxy antagonists, can completely block the analgesic effect of paracetamol due to pharmacodynamic interaction;
• simultaneous use of paracetamol and zidovudine causes a tendency to decrease the number of leukocytes (neutropenia), therefore these medicines should not be used simultaneously unless otherwise recommended by a doctor;
• Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, and alkaline drinks;
• Ascorbic acid, when taken orally, increases the absorption of penicillin, tetracycline, and iron, increases the level of ethinyl estradiol, reduces the effectiveness of heparin and indirect anticoagulants, and increases the risk of crystalluria during treatment with salicylates;
• simultaneous administration of vitamin C and deferoxamine increases tissue iron toxicity, especially in the heart muscle, which can lead to decompensation of the circulatory system; vitamin C can be taken only 2 hours after the injection of deferoxamine;
• high doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine, and disrupt the excretion of mexiletine by the kidneys;
• ascorbic acid increases the total clearance of ethyl alcohol;
• Quinoline drugs, calcium chloride, salicylates, and corticosteroids, when used for long periods of time, reduce the body’s stores of ascorbic acid.

Simultaneous use of Antiflu® ^Kids with the following drugs – hypnotics, sedatives, neuroleptics, tranquilizers – can significantly increase the suppressive effect of chlorpheniramine maleate.

Chlorpheniramine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, and antiparkinsonian drugs.

MAO inhibitors should not be used with antihistamines due to the potential for additive CNS depression. They may prolong and potentiate the anticholinergic effects of antihistamines.

No cases of overdose with Antiflu® Kids have been reported. Symptoms of an overdose of the drug consist of manifestations of intoxication of individual active ingredients.

In patients with risk factors, therapeutic doses of paracetamol may cause symptoms of overdose with the simultaneous use of certain drugs (see Interaction with other drugs), in diseases that increase oxidative stress and deplete glutathione reserves in the liver (prolonged fasting, sepsis, diabetes mellitus).

The most important effects of acute intoxication are hepatotoxicity – hepatocellular damage, which is caused by the binding of active metabolites of paracetamol to hepatocyte proteins. In therapeutic doses, these metabolites bind to glutathione and form non-toxic conjugates. In the case of a significant overdose, the reserves of SH-group donors (contribute to the formation of glutathione) in the liver are depleted. This leads to the accumulation of toxic metabolites and necrosis of hepatocytes with subsequent liver dysfunction, which progresses to hepatic coma.

Symptoms of acetaminophen overdose in the first 24 hours include pallor, nausea, vomiting, anorexia, general weakness, and abdominal pain. The patient’s condition may improve within 24 to 48 hours, although symptoms may persist. Psychomotor agitation or central nervous system depression, increased sweating, dizziness, and sleep disturbances may also occur at high doses.

Occasionally, nephrotoxicity has been observed from the urinary system, including renal colic, interstitial nephritis and acute renal failure with acute tubular necrosis, which may present with severe lower back pain, hematuria, proteinuria and may occur even in the absence of severe liver damage. In severe cases, liver damage (hepatocellular necrosis) and deterioration of liver function may occur, which may progress to hepatic encephalopathy, hepatic coma, cerebral edema and death. Clinical signs of liver damage may not appear for 12-48 hours after overdose. Liver size may increase rapidly. Disorders of glucose metabolism, hypokalemia and metabolic acidosis (including lactic acidosis), increased activity of hepatic transaminases, increased bilirubin levels and increased prothrombin index, hemorrhages. The amount of urine decreases. Mild azotemia may be observed. Liver damage may develop in a child after administration of 150 mg/kg body weight. Common clinical manifestations occurring after 3-5 days include jaundice, fever, hemorrhagic diathesis, hypoglycemia, hepatic halitosis, and liver failure.

The use of 5 g or more of paracetamol can lead to liver damage in patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that induce liver enzymes, regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia)).

Arrhythmia (heart rhythm disturbances) and pancreatitis have also been reported. When taken in high doses, CNS effects include disorientation.

With prolonged use in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia are possible.

Chronic intoxication includes various liver lesions. Data on chronic toxicity and especially nephrotoxicity of paracetamol are contradictory. With prolonged use, attention should be paid to the analysis of peripheral blood.

In case of an overdose of chlorpheniramine maleate, atropine-like symptoms may occur: mydriasis, photophobia, dry skin and mucous membranes, increased body temperature, tachycardia, intestinal atony, facial flushing. Usually, symptoms of CNS disorders are first noted (psychomotor agitation, psychosis, hallucinations, tremor, impaired motor coordination, hyperreflexia, convulsions), and then depression, drowsiness, impaired consciousness, accompanied by impaired breathing and cardiovascular function (cardiac rhythm disturbances, extrasystole, decreased heart rate, decreased blood pressure to vascular failure and death). Emergency care for poisoning with antihistamines consists of symptomatic and supportive treatment, including mechanical ventilation.

Emergency care. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Continuous monitoring of vital signs, laboratory data and the state of the cardiovascular system should be ensured. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or may lead to organ damage. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Gastric lavage should be performed within 6 hours of a suspected acetaminophen overdose. Hemodialysis and hemoperfusion contribute to the removal of the substance. Cytotoxic effects can be reduced by the administration of SH-group donors (methionine orally or cysteamine or N-acetylcysteine ​​​​iv) within 10 hours after overdose, as they bind to active metabolites and promote detoxification. N-acetylcysteine ​​may be effective for up to 48 hours after poisoning. The effectiveness of the antidote decreases sharply after this period.

Symptoms of ascorbic acid overdose. There is no evidence that this drug can be overdosed when taken according to recommendations. With a single use of excessive doses of the drug, nausea, vomiting, bloating and abdominal pain, itching, skin rashes, increased excitability are possible. With prolonged use in high doses, inhibition of the insular apparatus of the pancreas is possible (its function must be monitored), the development of cystitis, and accelerated formation of stones (urates, oxalates). The effects of an overdose of ascorbic acid can be attributed to severe hepatotoxicity due to an overdose of paracetamol.

High doses of ascorbic acid (3000 mg) can cause temporary osmotic diarrhea and gastrointestinal upset.

Treatment: wash the stomach, give the patient an alkaline drink, activated charcoal or other absorbents.

In the original packaging at a temperature not exceeding 25 °C.