Description overdue on 07/21/2014
- Latin name: Ibufen
- ATC code: M01AE01
- Active substance: Ibuprofen (Ibuprofen)
- Manufacturer: Medana Pharma TERPOL Group J.S., Co. (Poland)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use Ibufena (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Synonyms
- Babies
- With alcohol
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
The main active ingredient is Ibufena Ibuprofen - 100 mg per 5 ml of suspension.
The composition is enriched with the following auxiliaries:
- Cremophor RH-40;
- sodium phosphate dihydrate;
- magnesium aluminum silicate;
- sucrose;
- glycerol;
- propylene glycol;
- methyl hydroxybenzoate (E 218) and propyl (E 216);
- citric acid monohydrate;
- sodium carboxymethylcellulose;
- sodium saccharin;
- crospovidone;
- orange flavor - orange oil, ethanol, isopropyl alcohol;
- orange-yellow dye;
- purified water.
If the pharmaceutical formulation is in the form of capsules or tablets , The constituent components are:
- Ibuprofen (active drug substance) - 200 mg;
- macrogol 600;
- potassium hydroxide;
- purified water.
The shell consists of the following parts:
- liquid, crystallising sorbitol;
- patented blue dye E 131;
- maltitol liquid;
- gelatin.
Product form
The pharmacy pharmaceutical preparation is very popular because it can be found in such a wide list of Product:
- Oral suspension 100 ml in glass vials of amber glass. Drug orange liquid with a characteristic orange odor and a sweet taste with a slightly pungent, easily perceptible flavor. Under the influence of gravity internally of the vial contents may be divided into a pellet layer and, because of the drug before use components should be mixed until a uniform suspension. The cardboard packaging is 1 vial in combination with a special metering device with a scale.
- Ibufen D - A suspension for oral administration in plastic bottles of 120 ml (concentration of active ingredient corresponds to that of conventional form Ibufena - 100 mg of ibuprofen per 5 ml of solution). The scope of the package, besides the capacity of drug liquid, placed a special syringe dispenser in the amount of 1 pieces.
- Ibufen Forte - A stronger form of a pharmaceutical preparation in the form of an oral suspension. The concentration of active substance increased to 200 mg per 5 ml of liquid formulation. The vial into which the solution for 100 ml. The cardboard package contains 1 bottle with pharmaceuticals.
- Ultra Ibufen As Ibufen Forte is enhanced pharmaceutical form of the drug, further enriched with active ingredients in parts by weight to 200 mg. However, this comes in the form of the drug Gelatin capsules oval shapes that have a translucent blue shell (inner content is a viscous liquid). The plate of PVDC, PVC or aluminum foil 10 is secured capsules. The carton is placed 1 or 2 contour blister.
- Ibufen children is supplied in the form of soft capsules (traditional pills ) Of 200 mg each. Arranged on the tablets in the blisters 10 or 20 pieces. Contour cell plates are packed in cardboard boxes with obligatory note that Ibufen children.
Pharmacological action
Ibufen classified as non-steroidal anti-inflammatory pharmaceutical preparation, which has analgesic and antipyretic properties .
The active component of the drug is Ibuprofen . Its mechanism of action lies in the inhibition of the cyclooxygenase enzyme, which plays an important role in the metabolism of arachidonic acid, which reduces the prostaglandin synthesis . In response to these influences, it decreases the intensity of the inflammatory process, because prostaglandins are mediators of local pathological process. It normalizes body temperature, as the excitatory effect of preventing thermal center of the brain and reduces the generation of pain impulses in the nerve trunks of pathophysiological disease outbreak.
Analgesic Properties the active ingredient is also partly due to the decrease in the production of prostaglandins classes E, F, I. Complements the action is reducing the concentration biogenic amines and changes in receptor sensitivity nociceptive system . The maximum impact is expressed analgesic drug for inflammatory disease, where the amount of all these substances is enhanced by a damaging factor.
Antipyretic and analgesic effect develops much faster than the anti-inflammatory, since data on the relief of pathologic manifestations require lower dosages of the pharmaceutical preparation. Inhibition of inflammatory processes observed only 5-7 days of conservative readjustment pathophysiological process.
Pharmacodynamics and pharmacokinetics
The drug is used orally . Over 80 percent of the active constituents absorbed from the gastrointestinal tract. Time to achieve plasma concentrations independent of food intake : Fasting maximum number of active substances in the blood within 45 minutes and after meal - just over 1, 5-2, 5 hours. The components of the bloodstream of a pharmaceutical preparation capable of binding to plasma proteins (mainly albumin ) Is approximately 90 percent, allowing them to circulate in the body a relatively long period of time.
The joint cavity active ingredients penetrate slowly - the maximum concentration synovial fluid achieved 2-3 hours after administration of the pharmaceutical preparation, however, may be retained in the physiological environment of the body is longer than in plasma.
The drug is metabolized primarily in the liver, undergoing pre and post processing system. After absorption of the drug greater part (approximately 60 percent) in pharmacological terms inactive R-ibuprofen form is transformed into the active S-shape under the influence of internal factors organism.
60-90 per cent of the dose displayed by the kidneys in the form of metabolic products with glucuronic acid. To a lesser extent the pharmaceutical preparation is released in the bile and only 1 percent unchanged. Kinetics ibuprofen It is biphasic in nature and the half-life of 2-2, 5:00. A single dose is completely excreted from the body within 24 hours. Effect Ibufena as antipyretic, is 30 minutes after administration and lasts for about 6-8 hours, depending on the individual metabolic parameters.
Indications
Ibuprofen, the main active ingredient of the pharmaceutical preparation, possesses a wide spectrum of pharmacological action because it can be used in two ways. First of all, the scope of the drug includes fever and his ability to appoint the following situations:
- colds;
- acute respiratory disease ;
- flu ;
- sore throat (pharyngitis);
- childhood infectious diseases that are accompanied by intense fever ;
- post-vaccination reactions .
Ibufen also can be used as a painkiller in such pathological conditions, such as:
- tooth pain (including those caused by inflammatory processes);
- headache and migraine ;
- neuralgia ;
- algomenorrhea ;
- pain in muscles and joints (juvenile or chronic, arthritic and psoriatic arthritis . osteochondrosis , Ankylosing spondylitis - ankylosing spondylitis The defeat of joints at systemic lupus erythematosus and so on);
- neuralgic amyotrophy - Personeydzha disease-Turner ;
- teething Accompanied by pain;
- when all sorts of injuries, thermal and electrical burns.
Contraindications
- Individual hypersensitivity, acquired or hereditary intolerance composite component to the pharmaceutical and ibuprofen in particular;
- aspirin triad (" Aspirin asthma ») - The simultaneous development of bronchospasm hives and Allergic rhinitis the treatment is not narcotic painkillers;
- carbohydrate malabsorption by type galactose malabsorption glucose or deficiency of glucose-6-defosfatdegidrogenazy;
- Peptic duodenal ulcer or stomach ;
- propensity to frequent hemorrhage ;
- violation of plasma or platelet clotting (including hereditary diseases such as hemophilia syndrome hypocoagulation );
- hemorrhagic diathesis ;
- organic liver disease or kidney disease in severe stages of the disease process;
- third trimester pregnancy ;
- severe heart failure (especially in the decompensated stage);
- arterial hypertension ;
- angioneurotic angioedema ;
- polypous growths in the nasal cavity;
- in the pediatric department of the drug is used only after the age of 6 months and body weight of more than 7 kg.
Also, there are a number of states where the use of the drug is recommended only under the supervision of qualified medical personnel and regular diagnostic assays (eg during inpatient treatment in an appropriate institution):
- ulcerative colitis ;
- Crohn's disease ;
- dehydration and exsicosis ;
- chronic liver disease, kidney or heart;
- if the patient's life history found information transferred gastric ulcer or duodenal ulcer, recent surgical intervention.
Side effects
When conservative treatment Ibufenom may experience the following undesirable effects:
- On the part of the central nervous system: dizziness . headache , Violation of sleep, anxiety . drowsiness . depression , Reversible toxic amblyopia , Blurred vision, diplopia - Double vision.
- From hemopoiesis system: heart failure . tachycardia . thrombocytopenia . anemia , Increased blood pressure, leukopenia (manifested in the form of agranulocytosis).
- Digestive system: dyspeptic indigestion . diarrhea , Decreased appetite, heartburn . costiveness . flatulence , Violation of the excretory function of the liver, peptic ulcer with haemorrhagic outcome.
- The urinary system : acute renal failure , Nephrotic syndrome, which manifests itself mainly edema, polyuria . cystitis , Renal inflammation apparatus.
- Allergic reactions : itching and rashes, bronhospastichesky syndrome . rhinitis . angioneurotic angioedema . Stevens-Johnson syndrome and Lyell .
Instructions for use Ibufena (method and dosage)
Instructions on Ibufen Forte . Ibufen D As a simple Ibufen stipulates that the average single dose for adults is 5-10 mg per 1 kg body weight of repeating 3-4 times throughout the day. The maximum daily amount received drug should not exceed 30 mg per 1 kg of body weight. The course of conservative therapy is appointed individually by the attending physician, as shall be consistent with the indications for treatment and regular diagnostic performance of the body.
Pediatric use Ibufen syrup for children, instruction which requires a strict dosage of the pharmaceutical preparation on the basis of the age and body weight of the child (for children who eat solid food, the syrup can be replaced by a tablet, so the number of the received substances indicated in ml and in mg, depending on the formulation):
- 6 months to 1 year at 7-9 kg in weight - 2, 5 mL (50 mg) 3 times every 24 hours with the maximum daily concentration which is 7, 5 ml (150 mg).
- 1-3 years and 10-15 kg of weight of the child - the same number as in the age group of 6 months to a year, but 3-4 times a day and the maximum amount of the drug may be up to 10 ml (200 mg).
- At the age of 3-6 years, and weight of the patient in 16-20 kg - to take the dose is increased to 5 ml (100 mg) 4 times a day, with the maximum amount of the drug - 20 ml (400 mg).
- 9-12 years old and weighing 31 to 41 kg - child syrup used in an amount of 10 ml (200 mg) three times a day at a dosage of 30 ml (600 mg).
- At the age of 12 years and body weight over 41 kg is allowed to use 10 ml (200 mg). Children's drug already used 4 times a day. The maximum daily dose of 40 ml (800 mg).
Children Ibufen, instruction which is set out above, should be applied periodically, every 6 or 8 hours.
Overdose
When a drug overdose the following symptoms observed increased concentrations of the active components of the preparation:
- abdominal pain;
- nausea and vomiting ;
- inhibition of the reaction;
- noise in ears ;
- depression ;
- violations of sleep and wakefulness;
- metabolic acidosis ;
- hemorrhagic diathesis ;
- hypotension ;
- acute renal failure;
- Arrhythmia the type of tachycardia or bradycardia, depending on individual susceptibility to a change in the rhythm of the heart;
- fibrillation atria;
- convulsions;
- apnea ;
- coma (adverse effects of treatment, this is especially true for children of the age group up to 5 years).
Specific pharmacological analogue for Ibufena there. If symptoms of overdose symptomatic treatment is used. Showing actions such as:
- gastric lavage ;
- correction of acid-base balance of the body;
- appointment enterosorbents headed charcoal ;
- alkaline food ;
- correction blood pressure (depending on its level, and heart rhythm).
Cooperation
Do not combine the application Ibufena with other pharmaceuticals in this group, as acetylsalicylic acid Constituting component of most non steroidal anti-inflammatory agents reduces the therapeutic effect and increases the possibility of side effects.
Simultaneous use diuretics against the backdrop of Ibufena not recommended. During their interaction decreases the therapeutic effect of diuretics and increase the risk of kidney failure.
The drug reduces the effect of antihypertensives Especially pharmaceuticals, which the mechanism of the effect on blood pressure is inhibition of angiotensin-converting enzyme or effect on beta-adrenergic receptors. Concurrent with the allocation of reduced kidney that during prolonged therapy with these agents can lead to overdosing or more active display of side effects.
Ibufen enhances the action of a number of drugs:
- oral hypoglycemic agents used in diabetes (especially chemical derivatives of sulfonylurea insulin );
- fibrinolitikov and antiplatelet agents (largely increases the risk of bleeding complications);
- anticoagulants (mechanism of the therapeutic effects of which depends on the effects on protein synthesis function of the liver);
- toxic effects Methotrexate and preparations of lithium;
- increases plasma concentration Digoxin (the drug is capable of cumulation, because a pharmacokinetic effects will inevitably lead to severe overdose).
Ibufen D As other forms of the pharmaceutical preparation, is metabolized primarily in the liver, because of its metabolism for a cycle significantly affect inducers and inhibitors of microsomal oxidation . Drugs such as Fenition . Tricyclic antidepressants . Ethanol . Barbiturates . Phenylbutazone . Ziksorin . Rifampicin increase the production of hydroxylated active metabolites, which is manifested in increased risk of hepatotoxic complications. Mikosomalnogo oxidation inhibitors are the exact opposite.
Caffeine strengthens the analgesic effect ibuprofen .
Terms of sale
The drug is in the free market, that is to buy it at the drugstore can be certified without the receptor form.
Storage conditions
The pharmaceutical preparation should be stored protected from light and a place inaccessible to children at temperature from 15 to 25 degrees Celsius.
Shelf life
3 years (shelf life after first opening the bottle for the drug in the form of a syrup - 6 months).
Cautions
By gravity the constituent components of the drug may be separated by floating on the surface layers and the precipitate at the bottom, before each use because the drug must shake the vial until a homogeneous suspension.
In the long course of medical treatment of non-steroidal anti-inflammatory drugs can cause gradual damage to the gastric mucosa with the outcome of peptic ulcer or gastrointestinal bleeding . Therefore we recommend regular diagnostic tests acidic condition of gastric and intestinal juices.
A pharmaceutical preparation comprising sugar, because patients with diabetes It should be taken with caution.
Analogs
Analogs Ibufena up a whole group of non-steroidal anti-inflammatory drugs, which, as the main component of the drug to inhibit the enzyme cyclooxygenase and inhibit the production of prostaglandins . Most often, the therapeutic effect is replaced Nurofenom Because in the Pharmaceutical Forum is given a logical question.
Which is better: Ibufen or Nurofen?
Based on indications and side effects of both drugs, we can safely say that the question is not strictly correct. Nurofen is a more potent pharmaceutical drug because used in critical situations and serious diseases. For example, its use is more justified in rheumatoid arthritis, deforming osteoarthritis and ankylosing spondylitis.
Ibufen, thanks excipients and well chosen concentration of the active component, has a mild effect. His often prescribed for colds, flu or acute respiratory disease, as the drug has fewer side effects and anti-inflammatory effect develops only 5-7 days of conservative treatment. Also worth noting is that Ibufen more often used in pediatric practice.
Synonyms
Ibuprofen . Ibupron . Ibusan .
Babies
The drug is widely used in pediatric practice, however, it requires strict regulation of dosage based on the weight and age of the patient.
With alcohol
Active ingredients of the pharmaceutical formulation interact actively with alcohol in the systemic circulation, thereby may increase side effects from the gastrointestinal tract and central nervous system.
During pregnancy and lactation
.
breast-feeding
.
or . and
Pills For example,
tablets
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