Maxicold for children oral suspension 100 mg/5 ml orange 200 g bottle, 1 pc.

Composition

Composition for 5 ml:

Active ingredient: 

ibuprofen 100.0 mg.

Excipients: Polysorbate-80 (tween 80) 0.5 mg, glycerol 600,0 mg maltitol (maltitol liquid) 2111,25 mg*, sodium saccharin 10.0 mg, citric acid monohydrate 20,0 mg, sodium citrate dihydrate (sodium citrate 2-water) 25,45 mg, xanthan gum (xanthan gum) 35,0 mg**, sodium chloride 5.5 mg, domiphen bromide 0.5 mg, flavor, strawberry or orange flavor 12.5 mg, purified water to 5 ml.

Note. * The content of liquid maltitol is indicated.

**Depending on the viscosity of xanthan gum, it is allowed to adjust its content in the preparation from 25.0 to 35.0 mg/5 ml

. Pharmacological action

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction.

It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effect. Ibuprofen reversibly inhibits platelet aggregation.

Pharmacokinetics

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

Distribution. Plasma protein binding is 90%. Slowly penetrates the joint cavity, lingers 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 converted to the active S-form.

Output. It has a two-phase elimination kinetics, T_1/2 is equal to 1-2 hours. It is excreted by the kidneys (no more than 1% unchanged) and to a lesser extent – with bile.

Indications

Maxicold®for children is used from 3 months of life to 12 years as a:

• an 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.

• painkillers for mild or moderate intensity pain syndrome, including:: headache and toothache, migraines, neuralgia, ear and throat pain, sprains and other types of pain.

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

Use during pregnancy and lactation

The use of the drug is contraindicated in the third trimester of pregnancy. In the first and second trimesters of pregnancy, the drug can only be used if the intended benefit to the mother exceeds the potential risk to the fetus. An assessment of the intended benefit and potential risk should be carried out by the physician.

It was found that ibuprofen is detected in breast milk in very low concentrations. The minimum determined dose (0.0008% of the received dose) is unlikely to have an effect on the baby during breastfeeding. With prolonged use of the drug or when using high doses, it may be advisable to temporarily stop breastfeeding. To decide whether to stop breastfeeding during the use of the drug, you should consult a doctor.

Contraindications

Maxicold ® for children should not be used when:

• hypersensitivity to ibuprofen, acetylsalicylic acid or other NSAIDs, as well as other components of the drug;

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);

• ulcerative lesions of the gastrointestinal tract in acute phase;

• gastrointestinal bleeding;

• bleeding or perforation of the ulcer in the digestive disease, 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) of less than 30 ml/min) failure;

• confirmed hyperkalemia;

• severe heart failure, status after conducting coronary artery bypass surgery;

• the bleeding disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diathesis);

• intracranial hemorrhage;

• children’s age up to 3 months;

• pregnancy (III trimester);

• fructose intolerance (as it contains maltitol).

With caution

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

• the simultaneous intake of other NSAIDs;

• diseases of the gastrointestinal tract (peptic ulcer of the stomach or duodenum, ulcerous colitis, Crohn’s disease, bleeding in history), hepatic, renal failure (CC 30-60 ml/min);

• the presence of Helicobacter pylori infection;

• concomitant use of oral corticosteroids (e. g. prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective inhibitors of serotonin reuptake (including citalopram, fluoxetine, paroxetine, and sertraline), antihypertensive drugs, diuretics, lithium drugs, methotrexate;

• bronchial asthma, urticaria;

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

• severe somatic diseases;

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

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

• pregnancy (I-II trimester);

• lactation.

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, impaired liver function, hepatitis, increased activity of “liver” transaminases.

Nervous system disorders: headache, dizziness, psychomotor agitation, insomnia, depression, aseptic meningitis (in patients with autoimmune diseases).

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

Hematopoietic disorders: anemia, thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

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

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

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

Respiratory system disorders: shortness of breath.

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

Interaction

Caution should be exercised when ibuprofen is co-administered with the following medications::

– Acetylsalicylic acid or other NSAIDs may increase the risk of side effects. Caution should be exercised if acetylsalicylic acid is taken for CHD or cerebral circulatory disorders, because ibuprofen may reduce the effect of acetylsalicylic acid.

– Antihypertensive agents: ibuprofen weakens the effect of antihypertensive drugs (including slow calcium channel blockers and ACE inhibitors).

– Methotrexate: the elimination of methotrexate slows down. Patients with reduced renal function have a high risk of developing hepatotoxic reactions, even when using low doses of methotrexate (

– Some antacids may reduce the absorption of ibuprofen from the gastrointestinal tract, which may be important if you take ibuprofen for a long time.

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

– Cyclosporine and gold preparations enhance the effect of ibuprofen on prostaglandin synthesis in the kidneys, which is manifested by an increased risk of nephrotoxicity.

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

– Tacrolimus: concomitant use of ibuprofen and tacrolimus increases the risk of nephrotoxicity.

– Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and