Antiflu Kids powder for oral solution 5 x 12g — Made in Germany — Free Delivery

Pharmacological properties

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

Ascorbic acid (vitamin C), as a key component of the antioxidant and immune defense system, increases the adaptive capabilities of the body and increases its resistance to infections. It actively participates in the regulation of redox processes, in the metabolism of carbohydrates, the synthesis of steroid hormones, catecholamines and blood clotting. Strengthens collagen synthesis, stimulates regeneration processes, normalizes capillary permeability.

Chlorpheniramine maleate is an antihistamine of the alkylamine class, a blocker of H1-histamine receptors. Has 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 preparation are metabolized independently of each other.

Pharmacokinetics. After oral administration, acetaminophen is rapidly absorbed, mainly in the upper digestive tract. It is quickly distributed in tissues. The blood protein binding is 10%. Acetaminophen is metabolized in the liver: most of it binds 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 significantly worsens with violations of the 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, Cmax 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 unchanged, partly in the form of metabolites.

Chlorpheniramine maleate is metabolized in the liver. T½ is 8 hours. Chlorpheniramine maleate and its metabolites are excreted in the urine.

Indications

Prescribed to children aged 2 to 12 years with flu, SARS and colds to reduce body temperature, eliminate headache, muscle and joint pain, rhinorrhea, sneezing, lacrimation and other symptoms of inflammation of the mucous membrane of the upper respiratory tract and paranasal sinuses.

Application

Inside, regardless of food intake, after dissolving the contents of the package in a glass of hot (not boiling water) water. the recommended amount of water for dissolving the powder is usually the volume that the child drinks at one time (100-200 ml). a single dose for children aged 2–5 years is the contents of 1 package, for children 6–12 years old - 2 packages. if necessary, repeat the reception 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 medical supervision.

Children. Do not use in children under 2 years of age. It is necessary to consult a doctor before using the preparation in children aged 2–5 years.

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

Contraindications

Hypersensitivity to preparation components or other antihistamines; severe dysfunction of the liver (9 points on the child's scale - I drink) and / or kidneys, alcoholism, congenital deficiency of glucose-6-phosphate dehydrogenase; congenital hyperbilirubinemia (including Zhilber's syndrome); disorders of hematopoiesis, blood diseases, severe leukopenia, anemia, tendency to thrombosis; severe cardiac conduction disturbances, decompensated heart failure, bladder neck obstruction, pyloroduodenal obstruction; thrombosis, thrombophlebitis; severe forms of diabetes mellitus, angle-closure glaucoma; ulcers of the stomach and duodenum in the acute stage; children under 2 years of age.

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

MAO inhibitors should not be used in conjunction with antihistamines due to the possibility of additive CNS depression. They can lengthen and enhance the anticholinergic effect of antihistamines.

Side effects

In most cases, the preparation is well tolerated.

The following side effects may occur:

• on the part of the blood system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, dyspnea, heart pain), hemolytic anemia (if the patient has a deficiency of glucose-6-phosphate dehydrogenase), thrombocytopenia, thrombocytosis, hyperprothrombinemia, erythropenia, neutrozrophilic thrombosis purpura, leukopenia, bruising, or bleeding;
• from the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid or other NSAIDs;
• from the digestive tract: heartburn, nausea, vomiting, dry mouth, discomfort and pain in the epigastric region, hypersalivation, loss of 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 until the onset of diabetes mellitus;
• on the part of the hepatobiliary system: impaired liver function, increased activity of hepatic enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect);
• from the immune system: hypersensitivity reactions (including allergic reactions), anaphylactic reactions and anaphylactic shock;
• from the nervous system: headache, dizziness, psychomotor agitation and disorientation, anxiety, fear, sleep disturbances, drowsiness, insomnia, confusion, coma, convulsions, dyskinesia, behavior changes;
• on the part of 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 renal glomerular apparatus, crystalluria, formation of urate, cystine and / or oxalate stones in the kidneys and urinary tract;
• on the part of the organ of vision: violation of accommodation, dry eyes, mydriasis, visual impairment, increased intraocular pressure;
• from the side of metabolism: metabolic disorders of zinc, copper, hypokalemia;
• from the skin and subcutaneous tissues: itching, rash on the skin and mucous membranes (usually generalized rash, erythema, urticaria), allergic and angioedema, acute generalized exanthematous pustulosis, local preparation dermatitis, erythema multiforme (including) Stevens-Jones syndrome , toxic epidermal necrolysis (Lyell's syndrome), including death.

Special instructions

Simultaneous use with other preparations intended for the symptomatic treatment of colds and flu, preparations containing paracetamol should be avoided. do not exceed the indicated dose and the duration of the course of treatment. simultaneous use with other preparations containing paracetamol can lead to overdose. Paracetamol overdose can cause liver failure, which can lead to the need for liver transplantation or death.

Patients with reduced glutathione levels, such as severe infections such as sepsis, have an increased risk of metabolic acidosis when taking paracetamol. The symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.

If symptoms persist, you should see a doctor.

Long-term use of high doses can lead to liver and kidney damage; a large number of preparations used at the same time, alcoholism, alcoholic liver damage, sepsis or diabetes mellitus may increase the risk of hepatotoxicity of paracetamol (acetaminophen) in therapeutic doses.

It should be borne in mind that in patients with liver disease, the risk of hepatotoxic effects of paracetamol increases. It is necessary to consult a doctor regarding the possibility of using the preparation in patients with impaired renal and liver function of mild to moderate severity.

This medication is not recommended for concomitant use with sedatives or hypnotics.

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

Paracetamol may interfere with laboratory test results for glucose and uric acid levels in the blood.

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

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

Cases of severe skin reactions have been reported very rarely. If skin redness, rash, blistering or peeling occurs, stop using paracetamol and seek immediate medical attention.

1 packet (1 dose) contains 11.6 g of sugar, which should be taken into account by patients with diabetes mellitus and patients on a diet low in sugar. Take with caution in patients with diabetes mellitus. The simultaneous administration of the preparation with an alkaline drink reduces the absorption of ascorbic acid, therefore, you should not drink the powder with alkaline mineral water. Also, the absorption of ascorbic acid can be impaired in case of intestinal dyskinesia, enteritis and achilia.

This medication should not be used in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency due to sucrose content. If you have a history of intolerance to some sugars, consult your doctor before taking this medication.

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

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

Do not take this medicine with other medicines for the symptomatic treatment of colds and flu that contain paracetamol or antihistamines. If symptoms persist, you should see a doctor. If the headache becomes persistent, you should also see your doctor.

Chlorpheniramine may mask symptoms of hypersensitivity reactions and interfere with skin test results. Therefore, the use of the preparation should be discontinued a few days before these manipulations.

Use during pregnancy and lactation. Do not use.

The ability to influence the reaction rate when driving or working with 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 preparation.

Interactions

With simultaneous use 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 increase the hepato- and nephrotoxicity of acetaminophen;
• barbiturates reduce the antipyretic effect of acetaminophen;
• tetracycline increases the risk of acetaminophen-induced anemia and methemoglobinemia;
• with the simultaneous use of paracetamol with hepatotoxic agents, the toxic effect of preparations on the liver increases; do not use simultaneously with alcohol;
• acetaminophen reduces the effectiveness of diuretics;
• the 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 increases with the use of metoclopramide and domperidone and decreases with the use of cholestyramine;
• with simultaneous long-term use with coumarin derivatives (for example, warfarin) may enhance their effect with an increased risk of bleeding; patients using oral anticoagulants should consult a doctor, blood coagulation should be monitored;
• taking paracetamol (acetaminophen) can affect the results of determining blood glucose by glucose oxidase-peroxidase with abnormally high concentrations;
• taking paracetamol can affect the results of determining the level of urea in the blood by the phosphotungstic acid method;
• tropisetron and granisetron, type 3 5-hydroxytryptamine antagonists, can completely block the analgesic effect of paracetamol due to pharmacodynamic interaction;
• the simultaneous use of paracetamol and zidovudine leads to a tendency to a decrease in the number of leukocytes (neutropenia), therefore, these preparations should not be used simultaneously, unless otherwise recommended by a doctor;
• absorption of ascorbic acid decreases with the simultaneous use of oral contraceptives, the use of fruit or vegetable juices, alkaline drinks;
• oral ascorbic acid increases the absorption of penicillin, tetracycline, iron, increases the level of ethinyl estradiol, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates;
• the simultaneous intake of vitamin C and deferoxamine increases the tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system; vitamin C can be taken only 2 hours after deferoxamine injection;
• high doses of the preparation reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, disrupt the excretion of mexiletine by the kidneys;
• ascorbic acid increases the total clearance of ethyl alcohol;
• preparations of the quinoline series, calcium chloride, salicylates, corticosteroids, with prolonged use, reduce the reserves of ascorbic acid in the body.

The simultaneous use of Antiflu® Kids with the following preparations- hypnotics, sedatives, antipsychotics, tranquilizers - can significantly increase the inhibitory effect of chlorpheniramine maleate.

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

MAO inhibitors should not be used in conjunction with antihistamines due to the possibility of additive CNS depression. They can lengthen and enhance the anticholinergic effect of antihistamines.

Overdose

An overdose of Antiflu® kids has not been reported. symptoms of preparation overdose consist of manifestations of intoxication of individual active ingredients.

In patients with risk factors, therapeutic doses of paracetamol can cause overdose symptoms with the simultaneous use of certain preparations (see INTERACTIONS), for diseases that increase oxidative stress and deplete glutathione stores 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. At therapeutic doses, these metabolites bind to glutathione and form non-toxic conjugates. In the event of a significant overdose, the stores of SH-group donors (contributing to the formation of glutathione) in the liver are depleted. This leads to the accumulation of toxic metabolites and necrosis of hepatocytes, followed by impaired liver function, which progresses to hepatic coma.

Symptoms of an overdose due to the action of acetaminophen in the first 24 hours are pallor, nausea, vomiting, anorexia, general weakness and abdominal pain (abdominal pain). The patient's condition may improve over 24–48 hours, although symptoms may persist. When taken in high doses, psychomotor agitation or CNS depression, increased sweating, dizziness and sleep disturbance may also occur.

Occasionally, nephrotoxicity has been observed on the part of the urinary system, including renal colic, interstitial nephritis and ARF with acute tubular necrosis, which can manifest as severe pain in the lumbar region, hematuria, proteinuria, and develop even in the absence of severe liver damage. In severe cases, liver damage (hepatocellular necrosis) and deterioration of liver function may occur, which can progress to hepatic encephalopathy, hepatic coma, cerebral edema, and death. Clinical signs of liver damage may not appear for 12–48 hours after an overdose. The liver can grow in size rapidly. There may be a violation of glucose metabolism, hypokalemia and metabolic acidosis (including lactic acidosis), an increase in the activity of hepatic transaminases, an increase in the level of bilirubin and an increase in the prothrombin index, hemorrhage. The amount of urine decreases. Mild azotemia may occur. A child may develop liver damage after taking 150 mg / kg of body weight. Jaundice, fever, hemorrhagic diathesis, hypoglycemia, hepatic breath odor, liver failure belong to the frequent clinical manifestations that occur after 3-5 days.

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 preparations that induce liver enzymes, regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders , cystic fibrosis, HIV infection, starvation, cachexia)).

Arrhythmia (abnormal heart rhythm) and pancreatitis have also been reported. When taken in high doses from the central nervous system - disorientation.

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

Chronic intoxication includes various liver damage. The data on chronic toxicity and especially nephrotoxicity of paracetamol are contradictory. With prolonged use, you should pay attention 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, fever, tachycardia, intestinal atony, facial redness. Usually, symptoms of excitation of the central nervous system are first noted (psychomotor agitation, psychosis, hallucinations, tremors, impaired motor coordination, hyperreflexia, convulsions), and then - depression, drowsiness, impaired consciousness, accompanied by impaired respiration and cardiovascular function (cardiac arrhythmias, extrasystole , decrease in heart rate, decrease in blood pressure to vascular insufficiency and death). Emergency care for antihistamine poisoning is symptomatic and supportive treatment, including mechanical ventilation.

Urgent Care. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Continuous monitoring of vital functions, 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 the risk of 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 blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Gastric lavage should be performed within 6 hours after suspected acetaminophen overdose. Hemodialysis and hemoperfusion promote the elimination of the substance. Cytotoxic effects can be reduced by administering SH-group donors (oral methionine or cysteamine or N-acetylcysteine ​​IV) within 10 hours after overdose, since they bind to active metabolites and promote detoxification. N-acetylcysteine ​​can be effective up to 48 hours after poisoning. The effectiveness of the antidote declines sharply after this period.

Ascorbic acid overdose symptoms. There is no evidence that this preparation can be overdose when taken as recommended. With a single use of excessive doses of the preparation, nausea, vomiting, bloating and abdominal pain, itching, skin rash, hyperexcitability are possible. With prolonged use in high doses, it is possible to suppress the insular apparatus of the pancreas (it is necessary to control its function), the development of cystitis, and the acceleration of the formation of calculi (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: rinse the stomach, give the patient an alkaline drink, activated charcoal or other absorbents.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° c.