Maxikold for children suspension. d / int. approx. 100mg / 5ml fl. with measured. spoon 200g No. 1 (orange)

Dosage form

suspension from light gray or light gray with a yellowish shade of color to gray or gray with a yellowish shade with a characteristic fruity odor.

Structure

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.

pharmachologic effect

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.

Has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory action.

Ibuprofen reversibly inhibits platelet aggregation.

Pharmacokinetics

Suction.

It is 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.

The connection with plasma proteins is 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.

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, psychomotor 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 concentration of urea in the blood plasma.

Allergic reactions: skin rash, itching, urticaria, exacerbation of bronchial asthma, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, exudative 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.

Selling features

Available without a prescription

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 prep

Name ENG

MAXICOLD FOR CHILD

Clinical and pharmacological group

Analgesic-antipyretic combined composition

ATX code

Ibuprofen in combination with other drugs

Dosage

100mg / 5ml x 200g

Structure

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.

Indications

Used in children from 3 months of age to 12 years as:

antipyretic agent for:

acute respiratory viral diseases, including influenza,

acute bacterial infections (tonsillitis, tonsillitis, pneumonia, etc.),

childhood infections (measles, scarlet fever, chickenpox, etc.),

post-vaccination reactions,

other infectious and inflammatory diseases accompanied by high fever.

anesthetic for:

headache,

toothache, incl.

during teething and / or after tooth extraction,

migraine,

neuralgia,

ear pain, including otitis media,

sore throat

pain with sprains,

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

INN / Active ingredient

ibuprofen

Contraindications

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 to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history) ulcerative lesions of the gastrointestinal tract in the acute phase gastrointestinal bleeding 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, prolongation of bleeding time, tendency to bleeding, hemorrhagic diathesis) intracranial hemorrhage children under 3 months of age pregnancy (III trimester) intolerance to fructose (as it contains maltitol). With caution You should consult a 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 (in g.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.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.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.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.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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

after opening - 6 months

Specifications

Category

Pain and fever

Scope of the medicinal product

Ear, Throat, Nose

Release form

Oral suspension

Manufacturer country

Russia

Package quantity, pcs

one

Minimum age from

3 months

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

OTCPharm

Components

dosing device

The amount of the dosage form in the primary package

200 g

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M01AE01 Ibuprofen

Dosage form

Oral suspension, [orange]

Expiration date in days

730

Dosage (volume) of the substance in the preparation

5 ml - ibuprofen 100 mg

The target audience

Children

Package weight, g

360

Mode of application

:

The drug is taken orally. 5 ml of the drug contains 100 mg of ibuprofen. < br> Shake the bottle thoroughly before use. To accurately measure the dose of the drug, use the supplied measuring spoon or dosing syringe. < br> If a dosing syringe is used, proceed as follows: < br> 1. Insert the dosing syringe firmly into the neck of the bottle. < br> 2. Shake the suspension well. < br> 3. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the dosing syringe to the desired mark. < br> 4.Return the bottle to its original position and remove the dosing syringe by gently turning it. < br> 5. Place the dosing syringe into the child's mouth and slowly push the plunger, gradually releasing the suspension. < br> After use, rinse the dosing syringe in warm water and dry it out of the reach of the child. < br> 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! < br> Dosage for post-immunization fever: 2.5 ml for children under 1 year of age. Children over 1 year of age, if necessary, an additional 2.5 ml after 6 hours. Do not use more than 5 ml in 24 hours! < br> The drug should be taken no more often than every 6 hours! < br> Duration of treatment: < br> - not more than 3 days as an antipyretic < br> - not more than 5 days as an anesthetic < br> If you need a longer dose or if the drug is ineffective, you should consult your doctor.

Information on technical characteristics, delivery set, country of manufacture "