Ibuprofen-Akrikhin suspension for intravenous use 100 mg/5 ml fl 100 ml orange


Ibuprofen-Akrikhin suspension for intravenous use 100 mg/5 ml fl 100 ml orange

Compound

Active substance: ibuprofen - 2 g. Excipients: carmellose sodium - 0.97 g, macrogol glyceryl hydroxystearate - 1.14 g, sucrose - 34.2 g, glycerol - 5.7 g, magnesium aluminum silicate (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 - 0.14 g, orange flavor - 0.34 g, sunset yellow dye (E110) - 0.02 g, purified water - up to 100 ml.

Pharmacokinetics

Suction and distribution

After oral administration, more than 80% of ibuprofen is absorbed from the gastrointestinal tract. Cmax in blood plasma when taken on an empty stomach - 45 minutes, when taken after meals - 1.5-2.5 hours; in synovial fluid - 2-3 hours, where higher concentrations are created than in blood plasma. After absorption, approximately 60% of the pharmacologically inactive R form of ibuprofen is slowly transformed into the active S form.

Binding to plasma proteins (mainly albumin) is 90%.

Ibuprofen does not accumulate in the body.

Metabolism

Ibuprofen is biotransformed mainly in the liver.

Subject to presystemic and postsystemic metabolism.

Removal

Ibuprofen has a two-phase elimination kinetics with T1/2 2-2.5 hours. 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 no more than 1% is excreted unchanged. After taking a single dose, the drug is completely eliminated within 24 hours.

Indications for use

The drug is intended only for the treatment of children.

Increased body temperature of various origins with:

  • colds;
  • ARVI, incl. flu;
  • sore throat (tonsillitis);
  • childhood infections;
  • post-vaccination reactions.

Pain syndrome of various origins of weak and moderate intensity with:

  • toothache, painful teething;
  • ear pain due to inflammation of the middle ear;
  • headache, migraine;
  • neuralgia;
  • pain in muscles, joints, due to injuries of the musculoskeletal system.

Intended for symptomatic therapy, reducing pain and inflammation during the period of use, does not affect the progression of the disease.

Contraindications

  • hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to the auxiliary 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 NSAIDs (including a history);
  • erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute phase, ulcerative colitis, peptic ulcer, Crohn's disease - ulcerative colitis);
  • severe renal failure (creatinine clearance <30 ml/min), progressive kidney disease;
  • severe liver failure, active liver disease;
  • confirmed hyperkalemia;
  • inflammatory bowel diseases;
  • sucrase/isomaltase deficiency;
  • fructose intolerance, glucose-galactose malabsorption;
  • blood clotting disorders (including hemophilia, prolongation of bleeding time, bleeding tendency, hemorrhagic diathesis);
  • children up to 3 months old.

With caution: liver cirrhosis with portal hypertension; liver and/or kidney failure; arterial hypertension, chronic heart failure; nephrotic syndrome; hyperbilirubinemia; presence of Helicobacter pylori infection; peptic ulcer of the stomach and duodenum (history); gastritis; enteritis; colitis; blood diseases of unknown etiology (leukopenia and anemia); long-term use of NSAIDs; severe somatic diseases; simultaneous use of oral corticosteroids (including prednisolone); anticoagulants (including warfarin); antiplatelet agents (including clopidogrel). Ibuprofen-Akrikhin contains sugar, so it should be used with caution in patients with diabetes.

Directions for use and doses

The drug is taken orally after meals. Before use, the bottle should be shaken until a homogeneous suspension is obtained.

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

For precise dosing of the suspension, a dispenser (spoon or syringe) is attached to the bottle.

A single dose is 5-10 mg/kg body weight 3-4 times/day.

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

Age (body weight)Single doseFrequency of reception
6-12 months (7.7-9 kg)2.5 ml (50 mg)3 times/day
1-3 years (10-15 kg)2.5 ml (50 mg)3-4 times/day
4-6 years (16-20 kg)5 ml (100 mg)3 times/day
7-9 years (21-29 kg)5 ml (100 mg)4 times/day
10-12 years (30-41 kg)10 ml (200 mg)3 times/day

Taking the drug in a single dose can be repeated every 6-8 hours. The maximum daily dose should not be exceeded.

Infants from 3 to 6 months (5-7.6 kg) with post-vaccination reactions: 2.5 ml of the drug, if necessary, repeat 2.5 ml after 6 hours.

The daily dose of the drug for children from 3 to 6 months should not exceed 5 ml.

In children from 3 to 6 months, the drug can be used only after consultation with the attending physician.

Ibuprofen-Akrikhin can be used for no more than 3 days as an antipyretic and no more than 5 days as an analgesic.

If fever persists for more than 3 days, you should consult your doctor.

If pain persists for more than 5 days, you should consult a doctor.

Using a syringe dispenser:

1. Unscrew the cap of the bottle (press downwards and turn counterclockwise).

2. Press the dispenser firmly into the opening of the bottle neck.

3. Shake the contents of the bottle vigorously.

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

5. Turn the bottle over to its original position and carefully remove the dispenser from it with a rotating motion.

6. Place the tip of the dispenser in the child’s mouth, and then, slowly pressing the piston, introduce the contents of the dispenser.

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

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Best before date

3 years.
Do not use after expiration date. An opened bottle should be used within 6 months.

special instructions

In patients with bronchial asthma or other diseases associated with bronchospasm, ibuprofen may increase the risk of developing bronchospasm. The use of the drug in these patients is permissible only if great caution is observed, and in case of difficulty breathing, you should immediately consult a doctor.

During long-term treatment with NSAIDs, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

To prevent the development of NSAID gastropathy, it is recommended to combine it with prostaglandin E drugs (misoprostol). When symptoms of NSAID gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin, hematocrit, and a stool test for occult blood.

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

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

To reduce the risk of developing adverse events from the gastrointestinal tract, Ibuprofen-Akrikhin should be used in the minimum effective dose for the shortest possible short course.

1 ml of Ibuprofen-Akrikhin suspension contains about 0.34 g of sucrose, which corresponds to approximately 0.03 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); the maximum single dose of the drug, equal to 15 ml, contains 5.13 g of sucrose (corresponds to 0.45 XE)

Description

NSAIDs.

Dosage form

Oral suspension (orange) orange in color with an orange odor; separation into a liquid layer and sediment is allowed, which after mixing form a homogeneous suspension.

Use in children

In children from 3 to 6 months, the drug can be used only after consultation with the attending physician.

The use of the drug is contraindicated in children under 3 months of age.

Pharmacodynamics

NSAIDs. It has antipyretic, analgesic and anti-inflammatory effects.

The antipyretic effect is due to the blocking of COX-1 and COX-2 in the arachidonic acid cascade of the central nervous system, which leads to a decrease in the synthesis of prostaglandins, a decrease in their concentration in the cerebrospinal fluid and a decrease in excitation of the thermoregulation center. The effect of lowering temperature during fever begins 30 minutes after taking the drug, its maximum effect appears after 3 hours.

The leading mechanism of the analgesic effect is a decrease in the production of prostaglandins of classes E, F and I, biogenic amines, which leads to the prevention of the development of hyperalgesia at the level of changes in the sensitivity of nociceptors. The analgesic effect is most pronounced for inflammatory pain.

The anti-inflammatory effect is due to inhibition of COX activity and a decrease in the synthesis of prostaglandins in inflammatory foci, which leads to a decrease in the secretion of inflammatory mediators, a decrease in the activity of the exudative and proliferative phases of the inflammatory process.

Like other NSAIDs, ibuprofen exhibits antiplatelet activity.

Side effects

From the digestive system: NSAID gastropathy (nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, flatulence, pain and discomfort in the epigastric region); ulceration of the mucous membrane of the gums and 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 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 senses: hearing loss, ringing or tinnitus, reversible toxic optic neuritis, blurred vision or diplopia, impaired color vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma, amblyopia.

From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

From the cardiovascular system: development or worsening of heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

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

Other: increased sweating.

If any of the listed side effects occur, you should stop taking the drug and consult your doctor.

Use during pregnancy and breastfeeding

Prescribing Ibuprofen-Akrikhin during pregnancy is possible only if the potential benefit to the mother outweighs the possible risk to the fetus.
If it is necessary to prescribe Ibuprofen-Akrikhin during lactation, the issue of stopping breastfeeding should be decided.

Interaction

  • Ibuprofen should not be used simultaneously with other NSAIDs. For example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases side effects.
  • If possible, the simultaneous use of ibuprofen and diuretics should be avoided, due to the weakening of the diuretic effect and the risk of developing renal failure.
  • Ibuprofen reduces the hypotensive activity of vasodilators (including ACE inhibitors).
  • Ibuprofen enhances the effect of oral hypoglycemic agents (especially sulfonylureas) and insulin.
  • Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions.
  • Antacids and cholestyramine reduce the absorption of ibuprofen.
  • Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia.
  • Drugs with a myelotoxic effect increase the manifestations of hematotoxicity of the drug.
  • Cyclosporines and gold preparations enhance 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 developing its hepatotoxic effects.
  • Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.
  • Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications).
  • Increases the blood concentration of digoxin, methotrexate and lithium preparations.
  • Caffeine enhances the analgesic effect of ibuprofen.

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, respiratory arrest, acute renal failure, liver dysfunction, tachycardia, bradycardia , atrial fibrillation. Children under 5 years of age are especially prone to apnea, coma, and seizures.

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

Treatment: gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drinking, symptomatic therapy (correction of acid-base status, blood pressure).

Impact on the ability to drive vehicles and operate machinery

Considering the possibility of developing significant side effects, during the treatment period it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Ibuprofen-Akrikhin suspension vn prim orange 100 mg/5 ml 100 g x1

Registration number: P N011428/01 Trade name: Ibuprofen-Akrikhin

International non-patent name (INN): Ibuprofen

Chemical name: 2-(para-isobutylphenyl)-propionic acid

Dosage form: Oral suspension [orange]

Composition: 100 ml of suspension contains: Active substance: ibuprofen - 2.0 g. Excipients: carmellose sodium - 0.97 g, macrogol glyceryl hydroxystearate - 1.14 g, sucrose - 34.20 g, glycerol - 5.70 g, magnesium aluminum silicate (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 flavor - 0.34 g, sunset yellow dye (E 110) - 0.02 g, purified water - up to 100 ml.

Description: Suspension of orange color with an orange smell. It is possible to separate into a liquid layer and sediment, which after mixing form a homogeneous suspension.

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

ATX code: M01AE01

pharmachologic effect

Pharmacodynamics Ibuprofen has antipyretic, analgesic, and anti-inflammatory effects. The antipyretic effect consists of blocking cyclooxygenase (COX)-1 and 2 in the arachidonic acid cascade of the central nervous system, which leads to a decrease in the synthesis of prostaglandins (PGs), a decrease in their concentration in the cerebrospinal fluid and a decrease in excitation of the thermoregulatory center. The effect of lowering temperature during fever begins 30 minutes after taking the drug, its maximum effect appears after 3 hours. The leading analgesic mechanism is a decrease in the production of PG classes E, F and I, biogenic amines, which leads to the prevention of the development of hyperalgesia at the level of changes in the sensitivity of nociceptors. The analgesic effect is most pronounced for inflammatory pain. The anti-inflammatory effect is due to inhibition of COX activity and a decrease in PG synthesis in inflammatory foci, which leads to a decrease in the secretion of inflammatory mediators, a decrease in the activity of the exudative and proliferative phases of the inflammatory process. Like all NSAIDs, ibuprofen exhibits antiplatelet 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 albumin). The time to reach maximum concentration in blood plasma when taken on an empty stomach is 45 minutes, when taken after meals - 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 biphasic elimination kinetics with a half-life of 2-2.5 hours. Ibuprofen is metabolized mainly in the liver. Subject to presystemic and postsystemic metabolism. After absorption, approximately 60% of the pharmacologically inactive R form of ibuprofen is slowly transformed into the 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 no more than 1% is excreted unchanged. After taking a single dose, the drug is completely eliminated within 24 hours.

Indications for use

The drug is intended only for the treatment of children. Increased body temperature of various origins with:

• “colds”, • acute respiratory viral infections, including influenza, • sore throat (tonsillitis), • childhood infections, • post-vaccination reactions. Pain syndrome of various origins of weak and moderate intensity with:

•toothache, painful teething, •ear pain due to inflammation of the middle ear, •headache, migraine, •neuralgia, pain in muscles, joints, due to injuries of the musculoskeletal system. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

•Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to the auxiliary 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 NSAIDs (including history), • erosive and ulcerative diseases of the gastrointestinal 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 (CC) less than 30 ml/min), progressive kidney disease, severe liver failure or active liver disease, •confirmed hyperkalemia, •inflammatory bowel disease, •sucrase/isomaltase deficiency, •fructose intolerance, glucose-galactose malabsorption, •blood coagulation disorders (including including, hemophilia, prolongation of bleeding time, tendency to bleeding, hemorrhagic diathesis), • children up to 3 months. Carefully:

•liver cirrhosis with portal hypertension, •liver and/or renal failure, •arterial hypertension, chronic heart failure, •nephrotic syndrome, •hyperbilirubinemia, •presence of H. pylori infection, •peptic ulcer of the stomach and duodenum (history), • gastritis, •enteritis, •colitis, •blood diseases of unknown etiology (leukopenia and anemia), •long-term use of NSAIDs, •severe somatic diseases, •simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel). Ibuprofen-Akrikhin contains sugar, so it should be used with caution in patients with diabetes.

Directions for use and dosage: Orally, after meals. Before use, shake until a homogeneous suspension is obtained. For precise dosing of the suspension, a dispenser (spoon or syringe) is attached to the bottle. The dose is set depending on the age and body weight of the child. A single dose of Ibuprofen-Akrikhin is 5-10 mg/kg of 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 prescribed in a single dose according to the scheme below:

Age (body weight) Single dose Frequency of administration 6-12 months (7.7-9 kg) 2.5 ml 3-4 times 2.5 ml per day 1-3 years (10-15 kg) 5.0 ml 3 times 5.0 ml per day 4-6 years (16-20 kg) 7.5 ml 3 times 7.5 ml per day 7-9 years (21-29 kg) 10.0 ml 3 10.0 ml times 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.

Infants from 3 to 6 months (5-7.6 kg) with post-vaccination reactions: 2.5 ml of the drug, if necessary, repeat 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.

For children from 3 to 6 months of age, the drug can be used only after consultation with the attending physician.

The drug Ibuprofen-Akrikhin is used for no more than 3 days as an antipyretic and no more than 5 days as an analgesic.

If fever persists for more than 3 days, you should consult your doctor.

If pain persists for more than 5 days, you should consult a doctor.

Using a syringe-shaped dispenser: 1. Unscrew the cap of the bottle (press, pressing down, and turn counterclockwise). 2. Press the dispenser firmly into the opening of the bottle neck. 3. Shake the contents of the bottle vigorously. 4.To fill the dispenser, the bottle must be turned upside down, and then carefully move the dispenser piston down, pour in the contents until the desired mark on the scale is reached. 5. Turn the bottle over to its original position and carefully remove the dispenser from it with a rotating motion. 6. Place the tip of the dispenser in the child’s mouth, and then, slowly pressing the piston, introduce the contents of the dispenser. 7.After use, the bottle should be closed by screwing on the cap, and the dispenser should be rinsed with drinking water and dried. Side effect

From the digestive system: NSAID gastropathy (nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the mucous membrane of the gums and mucous membrane of the gastrointestinal tract (in some cases complicated 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 senses: hearing loss, ringing or tinnitus, reversible toxic optic neuritis, blurred vision or diplopia, impaired color vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma, amblyopia.

From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

From the cardiovascular system: development or worsening 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 itching, skin rash (erythematous or urticaria), angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia , allergic rhinitis.

Other: increased sweating.

If any of the listed side effects occur, you should stop taking the drug and consult your doctor.

Overdose

Symptoms of overdose: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, respiratory arrest, acute renal failure, liver dysfunction, tachycardia, bradycardia, atrial fibrillation. Children under 5 years of age are especially prone to apnea, coma, and seizures. Serious consequences associated with the toxic effect of the drug usually appear after taking a dose exceeding 400 mg/kg body weight. In case of overdose, consult a doctor immediately.

Treatment: gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drinking, symptomatic therapy (correction of acid-base status, blood pressure).

Interaction with other drugs

Ibuprofen should not be used simultaneously with other NSAIDs (for example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases side effects).

If possible, the simultaneous use of ibuprofen and diuretics should be avoided, due to the weakening of the diuretic effect and the risk of developing renal failure.

Ibuprofen reduces the hypotensive activity of vasodilators (including angiotensin-converting enzyme inhibitors).

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

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

Antacids and cholestyramine reduce the absorption of ibuprofen.

Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporines and gold preparations enhance 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 developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.

Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications).

Increases the blood concentration of digoxin, methotrexate and lithium preparations.

Caffeine enhances the analgesic effect.

special instructions

In patients with bronchial asthma or other diseases associated with bronchospasm, ibuprofen may increase the risk of developing bronchospasm. The use of the drug in these patients is permissible only if great caution is observed, and in case of difficulty breathing, you should immediately consult a doctor. During long-term treatment with NSAIDs, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. To prevent the development of NSAID gastropathy, it is recommended to combine it with prostaglandin E drugs (misoprostol). When symptoms of NSAID gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin, hematocrit, and a stool test for occult blood.

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

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

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose of Ibuprofen-Akrikhin should be used in the shortest possible short course.

1 ml of Ibuprofen-Akrikhin suspension contains about 0.34 g of sucrose, which corresponds to approximately 0.03 bread units (XU). Thus, the minimum single dose of the drug, equal to 2.5 ml, contains 0.85 g of sucrose (corresponding to 0.075 XE), the maximum single dose of the drug, equal to 15.0 ml, contains 5.13 g of sucrose (corresponding to 0.45 HE).

The drug does not have an antibacterial effect, and when treating angina, a doctor’s consultation is required to prescribe adequate therapy.

Driving vehicles and maintaining operating mechanical devices

Considering the possibility of developing significant side effects, during the treatment period it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form Oral suspension [orange] 100 mg/5 ml. 100 g in dark glass bottles with a screw-on polyethylene cap with a “first-opening” protective ring and a dispensing spoon, or 100 g in plastic bottles with a screw-on polyethylene cap with a “first-opening” protective ring and a dispensing syringe. Each bottle, along with instructions for use and a dispensing spoon or dispensing syringe, is placed in a cardboard box.

Storage conditions: Protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life: 3 years. An opened bottle must be used within 6 months. Do not use after expiration date.

Conditions for dispensing from pharmacies Without a prescription.

Manufacturer MEDANA PHARMA Joint Stock Company 98-200 Sieradz, st. Polish Military Organization 57, Poland

Organization that accepts consumer complaints OJSC Chemical and Pharmaceutical Plant AKRIKHIN 142450, Moscow region, Noginsky district, Staraya Kupavna, st. Kirova, 29 Phone/fax

Ibuprofen-Akrikhin

Registration number: P N011428/01 Trade name: Ibuprofen-Akrikhin

International non-patent name (INN): Ibuprofen

Chemical name: 2-(para-isobutylphenyl)-propionic acid

Dosage form: Oral suspension [orange]

Composition: 100 ml of suspension contains: Active substance: ibuprofen - 2.0 g. Excipients: carmellose sodium - 0.97 g, macrogol glyceryl hydroxystearate - 1.14 g, sucrose - 34.20 g, glycerol - 5.70 g, magnesium aluminum silicate (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 flavor - 0.34 g, sunset yellow dye (E 110) - 0.02 g, purified water - up to 100 ml.

Description: Suspension of orange color with an orange smell. It is possible to separate into a liquid layer and sediment, which after mixing form a homogeneous suspension.

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

ATX code: M01AE01

pharmachologic effect

Pharmacodynamics Ibuprofen has antipyretic, analgesic, and anti-inflammatory effects. The antipyretic effect consists of blocking cyclooxygenase (COX)-1 and 2 in the arachidonic acid cascade of the central nervous system, which leads to a decrease in the synthesis of prostaglandins (PGs), a decrease in their concentration in the cerebrospinal fluid and a decrease in excitation of the thermoregulatory center. The effect of lowering temperature during fever begins 30 minutes after taking the drug, its maximum effect appears after 3 hours. The leading analgesic mechanism is a decrease in the production of PG classes E, F and I, biogenic amines, which leads to the prevention of the development of hyperalgesia at the level of changes in the sensitivity of nociceptors. The analgesic effect is most pronounced for inflammatory pain. The anti-inflammatory effect is due to inhibition of COX activity and a decrease in PG synthesis in inflammatory foci, which leads to a decrease in the secretion of inflammatory mediators, a decrease in the activity of the exudative and proliferative phases of the inflammatory process. Like all NSAIDs, ibuprofen exhibits antiplatelet 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 albumin). The time to reach maximum concentration in blood plasma when taken on an empty stomach is 45 minutes, when taken after meals - 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 biphasic elimination kinetics with a half-life of 2-2.5 hours. Ibuprofen is metabolized mainly in the liver. Subject to presystemic and postsystemic metabolism. After absorption, approximately 60% of the pharmacologically inactive R form of ibuprofen is slowly transformed into the 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 no more than 1% is excreted unchanged. After taking a single dose, the drug is completely eliminated within 24 hours.

Indications for use

The drug is intended only for the treatment of children. Increased body temperature of various origins with:

• “colds”, • acute respiratory viral infections, including influenza, • sore throat (tonsillitis), • childhood infections, • post-vaccination reactions. Pain syndrome of various origins of weak and moderate intensity with:

•toothache, painful teething, •ear pain due to inflammation of the middle ear, •headache, migraine, •neuralgia, pain in muscles, joints, due to injuries of the musculoskeletal system. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

•Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to the auxiliary 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 NSAIDs (including history), • erosive and ulcerative diseases of the gastrointestinal 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 (CC) less than 30 ml/min), progressive kidney disease, severe liver failure or active liver disease, •confirmed hyperkalemia, •inflammatory bowel disease, •sucrase/isomaltase deficiency, •fructose intolerance, glucose-galactose malabsorption, •blood coagulation disorders (including including, hemophilia, prolongation of bleeding time, tendency to bleeding, hemorrhagic diathesis), • children up to 3 months. Carefully:

•liver cirrhosis with portal hypertension, •liver and/or renal failure, •arterial hypertension, chronic heart failure, •nephrotic syndrome, •hyperbilirubinemia, •presence of H. pylori infection, •peptic ulcer of the stomach and duodenum (history), • gastritis, •enteritis, •colitis, •blood diseases of unknown etiology (leukopenia and anemia), •long-term use of NSAIDs, •severe somatic diseases, •simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel). Ibuprofen-Akrikhin contains sugar, so it should be used with caution in patients with diabetes.

Directions for use and dosage: Orally, after meals. Before use, shake until a homogeneous suspension is obtained. For precise dosing of the suspension, a dispenser (spoon or syringe) is attached to the bottle. The dose is set depending on the age and body weight of the child. A single dose of Ibuprofen-Akrikhin is 5-10 mg/kg of 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 prescribed in a single dose according to the scheme below:

Age (body weight) Single dose Frequency of administration 6-12 months (7.7-9 kg) 2.5 ml 3-4 times 2.5 ml per day 1-3 years (10-15 kg) 5.0 ml 3 times 5.0 ml per day 4-6 years (16-20 kg) 7.5 ml 3 times 7.5 ml per day 7-9 years (21-29 kg) 10.0 ml 3 10.0 ml times 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.

Infants from 3 to 6 months (5-7.6 kg) with post-vaccination reactions: 2.5 ml of the drug, if necessary, repeat 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.

For children from 3 to 6 months of age, the drug can be used only after consultation with the attending physician.

The drug Ibuprofen-Akrikhin is used for no more than 3 days as an antipyretic and no more than 5 days as an analgesic.

If fever persists for more than 3 days, you should consult your doctor.

If pain persists for more than 5 days, you should consult a doctor.

Using a syringe-shaped dispenser: 1. Unscrew the cap of the bottle (press, pressing down, and turn counterclockwise). 2. Press the dispenser firmly into the opening of the bottle neck. 3. Shake the contents of the bottle vigorously. 4.To fill the dispenser, the bottle must be turned upside down, and then carefully move the dispenser piston down, pour in the contents until the desired mark on the scale is reached. 5. Turn the bottle over to its original position and carefully remove the dispenser from it with a rotating motion. 6. Place the tip of the dispenser in the child’s mouth, and then, slowly pressing the piston, introduce the contents of the dispenser. 7.After use, the bottle should be closed by screwing on the cap, and the dispenser should be rinsed with drinking water and dried. Side effect

From the digestive system: NSAID gastropathy (nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the mucous membrane of the gums and mucous membrane of the gastrointestinal tract (in some cases complicated 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 senses: hearing loss, ringing or tinnitus, reversible toxic optic neuritis, blurred vision or diplopia, impaired color vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma, amblyopia.

From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

From the cardiovascular system: development or worsening 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 itching, skin rash (erythematous or urticaria), angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia , allergic rhinitis.

Other: increased sweating.

If any of the listed side effects occur, you should stop taking the drug and consult your doctor.

Overdose

Symptoms of overdose: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, respiratory arrest, acute renal failure, liver dysfunction, tachycardia, bradycardia, atrial fibrillation. Children under 5 years of age are especially prone to apnea, coma, and seizures. Serious consequences associated with the toxic effect of the drug usually appear after taking a dose exceeding 400 mg/kg body weight. In case of overdose, consult a doctor immediately.

Treatment: gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drinking, symptomatic therapy (correction of acid-base status, blood pressure).

Interaction with other drugs

Ibuprofen should not be used simultaneously with other NSAIDs (for example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases side effects).

If possible, the simultaneous use of ibuprofen and diuretics should be avoided, due to the weakening of the diuretic effect and the risk of developing renal failure.

Ibuprofen reduces the hypotensive activity of vasodilators (including angiotensin-converting enzyme inhibitors).

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

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

Antacids and cholestyramine reduce the absorption of ibuprofen.

Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporines and gold preparations enhance 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 developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.

Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications).

Increases the blood concentration of digoxin, methotrexate and lithium preparations.

Caffeine enhances the analgesic effect.

special instructions

In patients with bronchial asthma or other diseases associated with bronchospasm, ibuprofen may increase the risk of developing bronchospasm. The use of the drug in these patients is permissible only if great caution is observed, and in case of difficulty breathing, you should immediately consult a doctor. During long-term treatment with NSAIDs, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. To prevent the development of NSAID gastropathy, it is recommended to combine it with prostaglandin E drugs (misoprostol). When symptoms of NSAID gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin, hematocrit, and a stool test for occult blood.

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

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

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose of Ibuprofen-Akrikhin should be used in the shortest possible short course.

1 ml of Ibuprofen-Akrikhin suspension contains about 0.34 g of sucrose, which corresponds to approximately 0.03 bread units (XU). Thus, the minimum single dose of the drug, equal to 2.5 ml, contains 0.85 g of sucrose (corresponding to 0.075 XE), the maximum single dose of the drug, equal to 15.0 ml, contains 5.13 g of sucrose (corresponding to 0.45 HE).

The drug does not have an antibacterial effect, and when treating angina, a doctor’s consultation is required to prescribe adequate therapy.

Driving vehicles and maintaining operating mechanical devices

Considering the possibility of developing significant side effects, during the treatment period it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form Oral suspension [orange] 100 mg/5 ml. 100 g in dark glass bottles with a screw-on polyethylene cap with a “first-opening” protective ring and a dispensing spoon, or 100 g in plastic bottles with a screw-on polyethylene cap with a “first-opening” protective ring and a dispensing syringe. Each bottle, along with instructions for use and a dispensing spoon or dispensing syringe, is placed in a cardboard box.

Storage conditions: Protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life: 3 years. An opened bottle must be used within 6 months. Do not use after expiration date.

Conditions for dispensing from pharmacies Without a prescription.

Manufacturer MEDANA PHARMA Joint Stock Company 98-200 Sieradz, st. Polish Military Organization 57, Poland

Organization that accepts consumer complaints OJSC Chemical and Pharmaceutical Plant AKRIKHIN 142450, Moscow region, Noginsky district, Staraya Kupavna, st. Kirova, 29 Phone/fax

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