Maxicold for children suspension orange 100mg / 5ml, 200g

Maxikold for children is used from 3 months of age to 12 years as:

• antipyretic agent for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases, accompanied by an increase in body temperature.

• an anesthetic for pain syndrome of mild to moderate intensity, including: headache and toothache, migraine, neuralgia, pain in the ears and throat, pain with sprains and other types of pain.

• The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

The drug is taken orally. 5 ml of the drug contains 100 mg of ibuprofen.

Shake the bottle thoroughly before use. To accurately measure the dose of the drug, use the supplied measuring spoon or dosing syringe.

If a dosing syringe is used, the following steps should be taken:

1.Push the dosing syringe firmly into the neck of the bottle.

2. Shake the suspension well.

3.Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the dosing syringe to the desired mark.

4. Return the vial to its original position and remove the dosing syringe by gently turning it.

5.Place the dosing syringe into the child's mouth and slowly push the plunger, gradually releasing the suspension.

After use, rinse the dosing syringe in warm water and dry it out of the reach of the child.

The dosage for children depends on the age and body weight of the child. A single dose is 5-10 mg / kg of the child's body weight 3-4 times a day. The maximum daily dose of ns should exceed 30 mg per kg of the child's body weight per day. Do not exceed the indicated dose!

Dosing for post-immunization fever: 2.5 ml for children under 1 year of age. Children over the age of 1 year, if necessary, an additional 2.5 ml after 6 hours. Do not use more than 5 ml in 24 hours!

The drug should be taken no more often than every 6 hours!

Duration of treatment:

- no more than 3 days as an antipyretic

-not more than 5 days as an anesthetic

If you need a longer intake or if the drug is ineffective, you should consult your doctor.

Composition for 5 ml:

Active ingredient: ibuprofen 100.0 mg.

Excipients: polysorbate-80 (tween 80) 0.5 mg, glycerol 600.0 mg, maltitol (liquid maltitol) 2111.25 mg *, sodium saccharinate 10.0 mg, citric acid monohydrate 20.0 mg, sodium citrate dihydrate (sodium 2-aqueous citrate) 25.45 mg, xanthan gum (xanthan gum) 35.0 mg **, sodium chloride 5.5 mg. domiphene bromide 0.5 mg, orange flavor 12.5 mg, purified water up to 5 ml.

Note.

* The content of liquid maltitol is indicated.

Maxicold for children should not be used with:

• hypersensitivity to ibuprofen. acetylsalicylic acid or other NSAIDs, as well as other components of the drug; Х complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history);

• ulcerative lesions of the gastrointestinal tract in the acute phase;

• gastrointestinal bleeding;

• a history of bleeding or perforation of gastrointestinal ulcers, provoked by the use of NSAIDs;

• inflammatory bowel diseases in the acute phase (Crohn's disease, ulcerative colitis);

• active liver disease;

• progressive kidney disease;

• severe hepatic, renal (creatinine clearance (CC) less than 30 ml / min) failure;

• confirmed hyperkalemia;

• severe heart failure, condition after coronary artery bypass grafting;

• blood clotting disorders (including hemophilia, prolonged bleeding time, bleeding tendency, hemorrhagic diathesis);

• intracranial hemorrhage;

• children under 3 months of age;

• pregnancy (III trimester);

• intolerance to fructose (as it contains maltitol).

  Carefully

  You should consult your doctor before using Maxicold for children in the following situations:

• concomitant use of other NSAIDs;

• diseases of the gastrointestinal tract (peptic ulcer or duodenal ulcer, ulcerative colitis, Crohn's disease, history of bleeding), hepatic, renal failure (CC 30-60 ml / min);

• presence of Helicobacter pylori infection;

• simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine , sertraline), antihypertensive drugs, diuretics, lithium drugs, methotrexate;

• bronchial asthma, urticaria;

• heart failure, arterial hypertension, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, fluid retention and edema;

• severe somatic diseases;

• systemic lupus erythematosus or other autoimmune diseases of the connective tissue (increased risk of developing aseptic meningitis);

• blood diseases of unknown etiology (leukopenia and anemia);

• pregnancy (1-11 trimester);

• lactation period.

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (POG-2), as a result of which it inhibits the synthesis of prostaglandins. It has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory action. Ibuprofen reversibly inhibits platelet aggregation.

Pharmokinetics

Suction. Well absorbed from the gastrointestinal tract (GIT). The time to reach the maximum concentration (TCmax) when taken on an empty stomach is 45 minutes, when taken after meals - 1.5-2.5 hours.

Distribution. Communication with plasma proteins - 90%. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating higher concentrations in it than in plasma.

Metabolism. Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into the active S-form.

Excretion. Has a two-phase elimination kinetics. T1 / 2 is equal to 1-2 hours. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with bile.

Overdose

If you accidentally exceed the recommended dose, see your doctor immediately.

Overdose symptoms: abdominal pain, nausea, vomiting, headache, tinnitus, metabolic acidosis, coma,

acute renal failure, lowering blood pressure, bradycardia, tachycardia.

Treatment: gastric lavage (only within an hour after ingestion), activated charcoal, alkaline drink,

forced diuresis, symptomatic therapy.

Side effects

When using the drug, the following side effects may occur:

From the gastrointestinal tract: nausea, vomiting, discomfort or pain in the epigastrium, diarrhea, flatulence, constipation, erosive and ulcerative lesions, bleeding, exacerbation of ulcerative colitis and Crohn's disease, ulcerative stomatitis, liver dysfunction, hepatitis, increased activity hepatic 'transaminases. From the nervous system ', headache, dizziness, agitation, insomnia, depression, aseptic meningitis (in patients with autoimmune diseases).

From the side of the cardiovascular system: tachycardia, increased blood pressure, heart failure, myocardial infarction, stroke.

From the side of hematopoiesis: anemia, thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

From the urinary system: impaired renal function, cystitis, papillary necrosis, acute renal failure, interstitial nephritis, peripheral edema, increased plasma urea concentration.

Allergic reactions: skin rash, itching, urticaria, exacerbation of bronchial asthma, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolayne syndrome.

From the senses: visual impairment, hearing loss, ringing in the ears.

From the respiratory system: shortness of breath.

If these or other side effects occur, you should stop using the drug and consult a doctor.

Special conditions

The risk of developing undesirable effects can be minimized by using the minimum effective dose and a short duration of therapy.

Before taking another drug from the NSAID group, you should consult your doctor.

Patients should always inform their doctor about any symptoms that occur during therapy.

If symptoms of ulcerative lesions or bleeding from the gastrointestinal tract appear, the drug should be discontinued, a doctor's consultation and careful monitoring of the condition, including esophagogastroduodenoscopy, a general blood test with determination of hemoglobin, hematocrit, and fecal occult blood test, should be indicated.

Precautions should be taken while taking drugs that increase the risk of gastrointestinal complications (including bleeding), such as glucocorticosteroids or anticoagulants (warfarin, acetylsalicylic acid) (see the section 'Interactions with other drugs).

Maxicold for children can be used in children with diabetes mellitus, because ns preparation contains sugar. The drug ns is recommended for patients with fructose intolerance, as it contains maltitol. Does not contain dyes.

Before starting therapy, patients with bronchial asthma or an allergic disease in the acute stage, as well as patients with a history of bronchial asthma / allergic disease, should consult a doctor, as the drug can provoke the development of broichospasm.

Before using the drug in patients with systemic lupus erythematosus or other autoimmune diseases of the connective tissue, it is necessary to consult a doctor, since the use of the drug is associated with an increased risk of developing aseptic meningitis.

Long-term drug therapy should be carried out under the supervision of a physician, e monitoring the picture of peripheral blood and the functional state of the liver and kidneys. Long-term use can increase the risk of acute coronary disease or stroke.

Before starting therapy, patients with a history of arterial hypertension and / or heart failure should be careful and consult a specialist, since such patients have been noted: fluid retention, hypertension and edema associated with taking NSAIDs.

During therapy with the drug, in very rare cases, a violation of hematopoiesis is possible. The first signs of impaired hematopoiesis may be fever, sore throat, superficial ulceration of the mouth, flu-like symptoms, severe weakness, nosebleeds, hemorrhagic skin rashes. If these symptoms occur, you must stop taking the drug and consult a doctor.

The drug may interfere with the determination of 17 - ketosteroids, so it should be discontinued 48 hours before the study.

During the period of treatment, it is not recommended to take ethanol.

Influence on the ability to drive vehicles and mechanisms

Patients who experience dizziness, headache, or visual impairment while taking ibuirofen. it is recommended to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention, speed of psychomotor and motor reactions.

Drug interactions

Caution should be exercised while using ibuprofen with the following drugs:

-Acetylsalicylic acid or other NSAIDs may increase the risk of side effects. Caution should be exercised if acetylsalicylic acid is taken for coronary artery disease or cerebrovascular accident, because ibuprofen can reduce the effect of acetylsalicylic acid.

- Antihypertensive drugs: ibuprofen weakens the effect of antihypertensive drugs (including slow calcium channel blockers and AIF inhibitors).

-Methotrexate: slows down the excretion of methotrexate. Patients with reduced renal function have a high risk of developing hepatotoxic reactions, even with low doses of methotrexate (<20 mg / week).

-Some antacids can reduce the absorption of ibuprofen from the gastrointestinal tract, which may be important with long-term ibuprofen use.

-Corticosteroids and selective serotonin reuptake inhibitors (including citalopram, fluoxegin, paroxetine, sertraline): increased risk of gastrointestinal bleeding.

-Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increased risk of pephrotoxicity.

-Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs can reduce the effectiveness of mifepristone.

-Tacrolimus: with the simultaneous use of ibuprofen and tacrolimus, the risk of nephrotoxicity increases.

-Zidovudine: Concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

- Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.

- The combined use of ibuprofen with cefamandol, csfoperazone, cefogetan, valproic acid, plicamicia increases the incidence of hypoprothrombinemia.

-Indicators of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbugazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions.

-Inhibitors of microsomal oxidation reduce the risk of hepatotoxic effects of ibuprofen.

-The use of ibuprofen together with thiazide diuretics reduces their effectiveness.

The drug enhances the side effects of mineralocorgicosteroids and glucocorticosteroids.

-Lithium: Ibuprofen slows down the elimination of lithium.

-Cardiac glycosides: NPVG1 can intensify the phenomena of heart failure, reduce the glomerular filtration rate and cause an increase in the level of glycosides in the blood plasma.

-Caffeine enhances the analgesic effect.

- Myelogoxic drugs increase the manifestations of hematotoxicity of the drug.

-Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

-Ibuprofen reduces the effectiveness of uricosuric drugs, enhances the effect of antiplatelet agents, fibrinolytics, thrombolytic drugs and insulin.

-Colestyramine reduces the absorption of ibuprofen.