Expiration date: 06/2025

Dosage form: 

Suspension for oral administration [orange]

Composition:

100 ml of the suspension contains:

Active substance: ibuprofen-2, 0 g.  

Excipients: sodium carmellose - 0, 97 g; macrogol glycerylmonostearate - 1, 14 g; sucrose - 34, 20 g; glycerol - 5, 70 g; magnesium aluminium silicate (veegum) - 0, 57 g; propylene glycol - 1, 71 g; methyl parahydroxybenzoate - 0, 15 g; parahydroxybenzoate - 0, 05 g; sodium phosphate dihydrate - 0, 46 g; citric acid monohydrate - 0, 91 grams; sodium saccharin - 0, 25 g; crospovidone - 1, 14 g; orange flavor - 0, 34 g; dye sunset yellow (E 110) - 0, 02 g; distilled water - upto 100 ml.

Description

Suspension orange with orange smell. 

Allowed the separation of the liquid layer and precipitate, which after stirring a homogenous suspension.

Pharmacotherapeutic group:

nonsteroidal anti-inflammatory drug (NSAID)

ATH code: M01AE01

Pharmacological action

Pharmacodynamics

Ibuprofen has antipyretic, analgesic, anti-inflammatory effect. The antipyretic effect is to block cyclooxygenase (COG)-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 thermoregulation center.

The reduction of temperature in fever begins within 30 minutes after taking the drug, the maximum effect through 3 hours.

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

The anti-inflammatory effect is due to the inhibition of COX activity and a decrease in the 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 antiplatelet activity.

Pharmacokinetics

After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract. 90% of the drug is associated with plasma proteins (mainly albumin).

The time to reach maximum concentration in plasma when taken on an empty stomach – 45 minutes at reception after meal 1, 5-2, 5 hours; in the synovial fluid 2-3 hours, where there are large concentrations than in plasma. 

The drug does not cumulate in the body. 

Ibuprofen has a two-phase elimination kinetics with a half-life period of 2-2, 5 hours.

Ibuprofen is metabolized mainly in the liver. Undergoes first-pass metabolism and postsistemnomu. After absorption about 60% pharmacologically inactive R-form ibuprofena 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 unchanged no more than 1%. 

After taking a single dose, the drug is completely excreted within 24 hours.

Indications for use

The drug is intended only for the treatment of children.

Increased body temperature of different Genesis at: 

• «catarrhal disease; 
  
• acute respiratory viral infections, including influenza; 
  
• sore throat (tonsillitis); 
  
• childhood infections; 
  
• post-vaccinal reactions.
  
• Pain syndrome of different origin of weak and moderate intensity in: 
  
• toothache, painful teething; 
  
• ear pain in inflammation of the middle ear; 
  
• headache, migraines; 
  
• neuralgia, pain in muscles, joints, due to injuries of the musculoskeletal system.
  

Designed for symptomatic therapy, reduce pain and inflammation at the time of use, the progression of the disease does not affect.

Contraindications

• Individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to the auxiliary components of the drug;
  
• full or partial combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including 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 (CC) less than 30 ml/ min), progressive kidney disease, severe hepatic insufficiency or active liver disease;
  
• confirmed hyperkalemia;
  
• inflammatory bowel disease;
  
• deficiency of sucrase/isomaltase;
  
• fructose intolerance, glucose-galactose malabsorption;
  
• disorders of blood coagulation (including hemophilia, prolonged bleeding time, bleeding tendency, bleeding diathesis);
  
• children's age up to 3 months.
  

With caution:

• cirrhosis of the liver with portal hypertension;
  
• hepatic and/or renal failure;
  
• arterial hypertension, chronic heart failure;
  
• nephrotic syndrome;
  
• hyperbilirubinemia;
  
• the presence of H. pylori infection;
  
• peptic ulcer of the stomach and duodenum (history);
  
• gastritis;
  
• enteritis;
  
• colitis;
  
• blood diseases of unclear etiology (leukopenia and anemia);
  
• long-term use of NSAIDs;
  
• severe somatic diseases;
  
• concomitant use of oral corticosteroids (including prednisone); anticoagulants (including warfarin); antiplatelet agents (including clopidogrel).
  
• Ibuprofen-quinacrine contain sugar, so you need to apply caution to his patients with diabetes.
  

Method of application and doses

Inside, after eating. 

Before use, shake well to obtain a homogeneous suspension. 

For accurate dosing of the suspension to the bottle attached dispenser (spoon or syringe). 

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 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)	??????? ????	????????? ??????
6-12 months (7-9 kg)	2.5 ml	3-4 times 2.5 ml during the day
1-3 years (10-15 kg)	5.0 ml	3 times 5.0 ml during the day
4-6 years (16-20 kg)	7.5 ml	3 times 7.5 ml during the day
7-9 years (21-29 kg)	10.0 ml	3 times 10.0 ml during the day
10-12 years (30-40 kg)	15.0 ml	3 times 15.0 ml during the day
The dose can be repeated every 6-8 hours. Do not exceed the maximum daily dose.

Infants 3 to 6 months (5-7. 6 kg) at post-vaccination reactions: 

2, 5 ml of the drug, if necessary, re-admission 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 the drug can be used only after consultation with the attending physician.

The drug is Ibuprofen-quinacrine is used not more than 3 days as an antipyretic, and not more than 5 days as a pain reliever.

If the fever persists more than 3 days, consult a doctor. 

If pain persists for more than 5 days, consult your doctor.

The use of the dispenser in the form of a syringe:

1. Unscrew the cap at the bottle (press down and turn counterclockwise). 

2. Hard to push the dispenser into the hole of the neck of the bottle. 

3. The contents of the bottle vigorously shake. 

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

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

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

7. After application, the bottle should be closed, screwing the lid, and the dispenser should be washed with drinking water and dried.

Side effect

From the digestive system: 

NSAID-induced 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 mucosa of the gastrointestinal tract (in some cases complicated by perforation and bleeding); dryness of the mucous membrane of the mouth, 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 excitation, irritability, confusion, hallucinations, rarely – aseptic meningitis (more often in patients with autoimmune diseases).

From the sensory organs: 

hearing loss, ringing or roaring in the ears, reversible toxic optic neuritis, blurred vision or diplopia, impaired color vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic Genesis), scotoma, amblyopia.

From hematopoietic organs: 

anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, 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 reaction: 

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

Other: 

increased sweating.

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

Overdose

Symptoms of overdose: 

abdominal pain, nausea, vomiting, obstruction, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, lowering blood PRESSURE, convulsions, respiratory arrest, acute renal failure, impaired liver function, tachycardia, bradycardia, atrial fibrillation. Children under 5 years are especially prone to apnea, coma and seizures. 

Serious consequences associated with the toxic effect of the drug are usually manifested after taking a dose exceeding 400 mg/kg body weight. 

In case of overdose, seek medical advice immediately.

Treatment: 

gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drink, symptomatic therapy (correction of acid-base state, blood PRESSURE).

Interaction with other drugs

You should not use ibuprofen along with other NSAIDs (e.g., acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen enhances the and side effects).

Should, whenever possible, to avoid the simultaneous application of ibuprofen and diuretics, due to the weakening of the diuretic effect and the risk of development of kidney disease.

Ibuprofen reduces the antihypertensive 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 severe hepatotoxic reactions.

Antacids and cholestyramine reduce the absorption of ibuprofen.

Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the frequency of gipoprotrombinemii.

Mielotoksicnae drugs increase the manifestation gematotoksichnosti drug.

Cyclosporins, gold preparations enhance the effect of ibuprofen on prostaglandin synthesis in the kidneys, which manifests an increase in nephrotoxicity.

Ibuprofen increases plasma concentration of cyclosporine and the probability of its hepatotoxic effects.

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

Enhances the effect of indirect anticoagulants, antiplatelets, fibrinolytics (increased risk of hemorrhagic complications).

Increases blood concentration of digoxin, methotrexate and lithium preparations.

Caffeine enhances the analgesic effect.

Special instruction

In patients with bronchial asthma or other diseases occurring with bronchospasm, ibuprofen can increase the risk of bronchospasm. The use of the drug in these patients is only valid subject to compliance with great care, and in the case of difficulty in breathing should immediately consult a doctor.

During long-term NSAID treatment needed to be monitored picture peripheral blood and functional state of the liver and kidneys. To prevent the development of NSAID-gastropathy should be combined with drugs of prostaglandin E (misoprostol). If you have symptoms of NSAID-gastropathy shows careful monitoring, including conducting esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood.

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

During the period of treatment is not recommended reception of the preparations containing ethanol.

To reduce the risk of adverse effects from the gastrointestinal tract should be used minimally effective dose of the drug Ibuprofen-quinacrine minimum possible short course.

In 1 ml of suspension of Ibuprofen-Akrikhin contains about 0, 34 g sucrose, which corresponds to about 0, 03 grain units (HE). Thus, the minimum single dose of the drug, equal to 2, 5 ml, contains 0, 85 g sucrose (corresponds to 0, 075 XE), the maximum single dose of the drug, equal to 15, 0 ml, contains 5, 13 g sucrose (corresponds to 0, 45 XE).

The drug does not have an antibacterial effect, and in the treatment of angina requires medical advice for the appointment of adequate therapy.

The driving of vehicles and maintenance of operating mechanical devices

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

Form release

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

100 g each into bottles of dark glass with a screw-on polyethylene lid with a protective ring " first opening "and a spoon dispenser, or 100 g into plastic bottles with a screw-on polyethylene lid with a protective ring" first opening " and a syringe dispenser. 

Each bottle together with the instruction on application and a spoon dispenser or syringe dispenser placed in a cardboard bundle.

Storage conditions

In a dark place at a temperature not exceeding 25°C. 

Keep out of reach of children.

Shelf life

3 years. 

The opened bottle must be used within 6 months. 

Do not use after the expiry date.

Conditions of supply of pharmacies

Without a prescription.