Ibuprofen-Akrihin - instructions for use, dose, side effects, contraindications

Excipients: carmellose sodium - 0.97 g; macrogol glyceryl hydroxy stearate 1.14 g; sucrose - 34.20 g; glycerol 5.70 g; magnesium aluminosilicate (veegum) - 0.57 g; propylene glycol -1.71 g; methyl parahydroxybenzoate 0.15 g; propyl parahydroxybenzoate 0.05 g; sodium phosphate dihydrate 0.46 g; citric acid monohydrate 0.91 g; sodium saccharinate - 0.25 g; crospovidone - 1.14 g; orange flavoring - 0.34 g; dye sunset sunset yellow (E 110) - 0.02 g; purified water - up to 100 ml.

Description:

Suspension orange with orange smell.

It is possible to separate the liquid layer and the sediment, which after mixing are a homogeneous suspension.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen has antipyretic, analgesic, anti-inflammatory effect. The antipyretic action consists in blocking cyclooxygenase (COX) - 1 and 2 in the cascade of arachidonic acid of the central nervous system, which leads to a decrease in the synthesis of prostaglandins (PG), a decrease in their concentration in the cerebrospinal fluid, and a decrease in the excitation of the thermoregulatory center. The effect of lowering fever temperature begins 30 minutes after taking the drug, its maximum effect is manifested after 3 hours.

The leading analgesic mechanism is the decrease in the production of GH E, F and I classes, biogenic amines, which leads to prevention of hyperalgesia at the level of nociceptor sensitivity change. Analgesic effect is most pronounced for inflammatory pains.

The anti-inflammatory effect is caused by oppression of COX activity and decreased synthesis of PG in inflammatory foci, which leads to a decrease in the secretion of inflammatory mediators, a decrease in the activity of the exudative and proliferative phase of the inflammatory process.

Like all NSAIDs ibuprofen exhibits antiaggregant activity.

Pharmacokinetics:

After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract. 90% of the drug binds to blood plasma proteins (mainly with albumins). Time to reach the maximum concentration in blood plasma when taking on an empty stomach is 45 minutes, when taken after a meal - 1,5-2,5 hours; in synovial fluid - 2-3 hours, where higher concentrations are created than in blood plasma. The drug does not accumulate in the body.

Ibuprofen has a two-phase kinetics of elimination with a half-life of 2-2.5 hours. Metabolized ibuprofen, mainly in the liver. It is subject to presystemic and post-systemic metabolism. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into an active S-form. 60-90% of the drug is excreted by the kidneys in the form of metabolites and products of their conjugation with glucuronic acid, to a lesser extent, with bile and in unchanged form is not more than 1%. After taking a single dose, the drug is completely excreted within 24 hours.

Indications:

The drug is intended only for the treatment of children.

- The raised temperature of a body of a various genesis at:

- "catarrhal" diseases;

- acute respiratory viral infections, including influenza;

- angina (tonsillitis);

- children's infections;

- postvaccinal reactions.

- Pain syndrome of different origin of weak and moderate intensity with:

- toothache, painful teething;

- ear pain with inflammation of the middle ear;

- headache, migraine;

- neuralgia, pain in the muscles, joints, as a result of injuries of the musculoskeletal system.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to auxiliary components of the drug;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history);

- erosive and ulcerative diseases of the digestive tract (including peptic ulcer of the stomach and duodenum in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease - ulcerative colitis);

- severe renal failure (creatinine clearance less than 30 mL / min), progressive kidney disease, severe hepatic impairment, or active liver disease;

- confirmed hyperkalemia;

- inflammatory bowel disease;

- deficiency of sugar / isomaltase;

- intolerance to fructose, glucose-galactose malabsorption;

- disorders of blood clotting (including hemophilia, lengthening bleeding time, a tendency to bleeding, hemorrhagic diathesis);

- children's age up to 3 months.

Carefully:Cirrhosis of the liver with portal hypertension; hepatic and / or renal insufficiency; arterial hypertension, chronic heart failure; nephrotic syndrome; hyperbilirubinemia; presence of H. pylori infection; peptic ulcer of the stomach and duodenum (in the anamnesis); gastritis; enteritis; colitis; blood diseases of unclear etiology (leukopenia and anemia); long-term use of NSAIDs; severe physical illness; simultaneous administration of oral glucocorticosteroids (including prednisolone); anticoagulants (including warfarin); antiaggregants (including clopidogrel). Ibuphen® contains sugar, so it must be used with caution in patients with diabetes mellitus.

Dosing and Administration:

Inside, after eating.

Shake before use until a uniform suspension is obtained.

To accurately dispense the suspension, a dispenser (spoon or syringe) is attached to the vial.

The dose is determined depending on the age and body weight of the child.

A single dose of the drug Ibufen® is 5-10 mg / kg of the child's body weight 3-4 times a day.

The maximum daily dose of the suspension is 20-30 mg / kg body weight.

The drug is given in a single dose according to the scheme below:

Age (body weight)	Single dose	Multiplicity of reception
6-12 months (7.7-9 kg)	2.5 ml	3-4 times at 2.5 ml per day
1-3 lay down (10-15 kg)	5.0 ml	3 times 5.0 ml each day
4-6 years (16-20 kg)	7.5 ml	3 times in 7,5 ml during the day
7-9 years (21-29 kg)	10.0 ml	3 times 10.0 ml per day
10-12 years (30-40 kg)	15.0 ml	3 times 15.0 ml per day
The dose can be repeated every 6-8 hours. Do not exceed the maximum daily dose.

Breast children from 3 to 6 months (5-7.6 kg) with postvaccinal reactions: 2.5 ml of the drug, if necessary, repeated intake of 2.5 ml after 6 hours.

The daily dose of the drug for children from 3 to 6 months should not exceed 5.0 ml.

Children from 3 to 6 months of the drug can be used only after consulting a doctor.

The preparation of Ibufen® is applied no more than 3 days as an antipyretic agent and no more than 5 days - as an anesthetic.

If the fever persists for more than 3 days, you should consult your doctor. If the pain remains for more than 5 days, you should consult your doctor.

Use of the dispenser in the form of a syringe:

1. Unscrew the cap from the bottle (press, pressing down, and turn counter-clockwise).

2. Strongly push the dispenser into the opening of the neck of the vial.

3. The contents of the vial should be vigorously shaken.

4. To fill the dispenser, the bottle must be turned upside down, and then gently move the dispenser piston down, pour the contents until the desired mark on the scale is reached.

5. Turn the bottle back to its original position and carefully remove the dispenser from it by rotating motion.

6. The tip of the dispenser is placed in the mouth of the child, and then slowly pressing the plunger, enter the contents of the dispenser.

After use, the bottle should be closed by screwing the lid on and the dispenser rinsed with drinking water and dried.

Side effects:

From the digestive system: NSAIDs-gastropathy (nausea, vomiting, decreased appetite, heartburn, abdominal pain, diarrhea, flatulence, pain and discomfort in the epigastric region); ulceration of the mucous membrane of the gums and the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding); dryness of the oral mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the central nervous system: headache, dizziness, sleep disturbance, anxiety, drowsiness, depression, psychomotor agitation, irritability, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, impaired color vision, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis), scotoma, amblyopia.

On the part of the organs of hematopoiesis: anemia (including, hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.

From the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure (BP). From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

Allergic reactions: skin itch, skin rash (erythematous or urticaria), angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever,multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

Other: increased sweating.

In case of any of the listed side effects, stop taking the medication and consult a doctor.

Overdose:

Symptoms of overdose: pain in the abdomen, nausea, vomiting, retardation, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, respiratory arrest, acute renal failure, liver dysfunction, tachycardia, bradycardia, fibrillation of the atria. Children under 5 years are especially prone to apnea, coma and convulsions.

Serious consequences associated with the toxic effect of the drug manifest themselves usually after taking a dose exceeding 400 mg / kg body weight. In case of an overdose, immediately consult a doctor.

Treatment: gastric lavage - (only within an hour after taking the drug), Activated carbon, alkaline drink, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

Do not use ibuprofen simultaneously with other NSAIDs (for example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases the side effect).

If possible, avoid simultaneous use of ibuprofen and diuretics, due to the weakening of the diuretic effect and the risk of developing kidney failure. Ibuprofen reduces the hypotensive activity of vasodilators (including angiotensin-converting enzyme inhibitors).

Ibuprofen enhances the effect of oral hypoglycemic agents (especially sulfonylurea derivatives) and insulin.

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

Antacids and colestramine reduce the absorption of ibuprofen.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

Myelotoxic agents increase the manifestation of hematotoxicity of the drug.Cyclosporins, gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

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

Strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytic drugs (increased risk of hemorrhagic complications). Increases the concentration in the blood of digoxin, methotrexate and lithium preparations. Caffeine strengthens the analgesic effect.

Special instructions:

In patients with bronchial asthma or other diseases that occur with bronchospasm, ibuprofen may increase the risk of developing bronchospasm. The use of the drug in these patients is permissible only under the condition of great care, and in case of difficulty in breathing, consult a doctor immediately. During the long-term treatment of NSAIDs, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.To prevent the development of NSAIDs-gastropathy it is recommended to combine with prostaglandin E preparations (misoprostol). When symptoms of NSAID-gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

During the period of treatment, it is not recommended to take medications containing ethanol. To reduce the risk of developing adverse events from the gastrointestinal tract, a minimally effective dose of Ibuphen® should be used in the shortest possible minimum course.

In 1 ml of the suspension of the preparation Ibufen® contains about 0.34 g of sucrose, which corresponds to approximately 0.03 bread units (XE). Thus, the minimum single dose of the drug equal to 2.5 ml contains 0.85 g of sucrose (corresponding to 0.075 XE), in the maximum single dose of 15.0 ml, contains 5.13 g of sucrose (corresponding to 0 , 45 XE). .

The drug does not have antibacterial action, and in the treatment of angina, a doctor's consultation is required to prescribe adequate therapy.

Effect on the ability to drive transp. cf. and fur:Given the potential for the development of significant side effects, during the treatment period, care must be taken when driving vehicles and engaging in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Form release / dosage:

Suspension for oral administration [orange] 100 mg / 5 ml.

Packaging:

100 grams in bottles of dark glass with a screwed polyethylene lid with a protective ring "first opening" and a spoon-dispenser, or 100 grams in plastic bottles with a screwed polyethylene lid with a protective ring "first opening" and syringe dispenser.

Each vial with instructions for use and a spoon-dispenser or syringe-dispenser is placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C. Keep in original packaging to protect from light. Keep out of the reach of children.

Shelf life:

3 years.

> The vial should be used within 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011428 / 01

Date of registration:08.04.2009

The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland

Manufacturer: & nbsp

MEDANA PHARMA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp20.10.2017

Illustrated instructions

Instructions

Ibuprofen-Akrihin (Ibuprofen-Akrichin)