IBUFEN oral suspension with raspberry flavor 100ml 100mg/5ml


IBUFEN oral suspension with raspberry flavor 100ml 100mg/5ml

When using the drug, caution should be exercised in patients with: - systemic lupus erythematosus and mixed connective tissue disease,

— diseases of the gastrointestinal tract, as well as chronic inflammatory bowel diseases (ulcerative colitis, Lesniewski’s disease and Crohn’s disease),

• hypertension and (or) heart failure,

• kidney failure,

• liver failure,

• blood clotting disorders (ibuprofen may prolong bleeding time).

Taking the drug in the recommended dose as soon as possible to reduce symptoms reduces the risk of side effects (see below: effects on the gastrointestinal tract and circulatory system).

The incidence and intensity of side effects can be reduced by using the minimum therapeutic dose over a shorter period of use.

Taking the drug in persons with bronchial asthma and other allergic diseases, in the active stage or in history, can cause bronchospasm.

There is a risk of gastrointestinal bleeding, ulceration or perforation; in the event of gastrointestinal bleeding or ulceration, the drug product should be stopped immediately. Patients with a history of gastrointestinal diseases should be informed of the need to notify the physician of any unusual gastrointestinal symptoms (in particular bleeding), especially during the initial period of therapy. Such patients should take a minimum dose of the drug.

Those that increase the risk of gastrointestinal disorders or bleeding, for example, corticosteroids and antithrombotic drugs such as warfarin, or antiplatelet drugs such as acetylsalicylic acid.

Clinical studies and epidemiological data suggest that taking ibuprofen, especially in high doses (2400 mg per day) for a long time, may be associated with a small increase in the risk of arterial embolism (eg heart attack or stroke). In general, epidemiological studies do not show that taking low doses of ibuprofen (eg.

Simultaneous long-term use of different analgesic drugs can lead to kidney damage and the risk of renal failure (postanalgesic nephropathy).

Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrosis (Lyell's syndrome) have been reported extremely rarely in association with the use of NSAID drugs. The greatest risk of these severe reactions occurs at the beginning of therapy, in most cases in the first month of using the drug. If the first symptoms occur: skin rash, damage to the mucous membrane or other symptoms of hypersensitivity, the drug should be discontinued.

It has been proven that drugs that inhibit cyclooxygenase (prostaglandin synthesis) can cause fertility disorders in women, affecting ovulation. This effect is temporary and stops after completion of therapy.

Isolated cases of toxic amblyopia have been reported with the use of ibuprofen, so any visual disturbances should be reported to your doctor.

The drug contains sodium benzoate, so it should be prescribed with great caution to patients with hypersensitivity, especially children with atopic changes and asthma.

The drug should not be prescribed to patients with rare genetic fructose intolerance.

Description of the drug IBUFEN D

With simultaneous use, ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).

When used simultaneously with anticoagulants, their effect may be enhanced.

When used simultaneously with GCS, the risk of side effects from the gastrointestinal tract increases.

When used simultaneously, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), and oral hypoglycemic drugs, sulfonylurea derivatives, from compounds with blood plasma proteins.

When used simultaneously with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid - the concentration of ibuprofen in the blood plasma decreases; with baclofen - a case of increased toxic effects of baclofen has been described.

When used simultaneously with warfarin, an increase in bleeding time is possible; microhematuria and hematomas were also observed; with captopril - the antihypertensive effect of captopril may be reduced; with cholestyramine - a moderate decrease in the absorption of ibuprofen.

When used simultaneously with lithium carbonate, the concentration of lithium in the blood plasma increases.

When used simultaneously with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate - the toxicity of methotrexate increases.

The simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.

There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.

With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.

NSAIDs may reduce the effectiveness of mifepristone, so taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.

Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ibuprofen.

In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.

In patients receiving concomitant NSAIDs and myelotoxic drugs, hematotoxicity increases.

With the simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the incidence of hypoprothrombinemia increases.

With the simultaneous use of ibuprofen and drugs that block tubular secretion, there is a decrease in excretion and an increase in plasma concentration of ibuprofen.

With the simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), there is an increase in the production of hydroxylated active metabolites and an increased risk of developing severe intoxications.

Overdose

Symptoms:

abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, hemorrhagic diathesis, decreased blood pressure, acute renal failure, liver dysfunction, tachycardia, bradycardia, atrial fibrillation; convulsions, apnea and coma (especially typical for children under 5 years of age).

Treatment:

gastric lavage, administration of activated carbon, alkaline drinking, symptomatic therapy (correction of acid-base balance, blood pressure).

Directions for use and doses

Inside

, after meal.
The average single dose is 5–10 mg/kg body weight 3–4 times a day. Children aged 6 months - 1 year (7-9 kg)
- 2.5 ml (50 mg) 3 times a day, maximum daily dose - 7.5 ml (150 mg).
1-3 years (10-15 kg)
- 2.5 ml (50 mg) 3-4 times a day, maximum daily dose - 7.5-10 ml (150-200 mg).
3-6 years (16-20 kg)
- 5 ml (100 mg) 3 times a day, maximum daily dose - 15 ml (300 mg).
6-9 years (21-30 kg)
- 5 ml (100 mg) 4 times a day, maximum daily dose - 20 ml (400 mg).
9-12 years (31-41 kg)
- 10 ml (200 mg) 3 times a day, maximum daily dose - 30 ml (600 mg).
Over 12 years (over 41 kg)
- 10 ml (200 mg) 4 times a day, maximum daily dose 40 ml (800 mg). The dose can be repeated every 6–8 hours. Do not exceed the maximum daily dose. For children from 6 months to 1 year, the drug is prescribed on the recommendation of a doctor.

Pharmacokinetics

After oral administration, more than 80% is absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved when taken on an empty stomach - after 45 minutes, when taken after meals after 1.5–2.5 hours. Protein binding - 90%. Slowly penetrates into the joint cavity, but in the synovial fluid it creates higher concentrations than in the blood plasma (Cmax in the synovial fluid is reached after 2–3 hours). Metabolized mainly in the liver. Subject to pre- and post-systemic metabolism. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Excreted by the kidneys (60–90% in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent with bile, unchanged - no more than 1%). It has a two-phase elimination kinetics with T1/2 of 2–2.5 hours, after taking a single dose it is completely eliminated within 24 hours. The antipyretic effect of Ibufen develops after 30 minutes and lasts 6–8 hours.

Nosological classification (ICD-10)

  • G43 Migraine
  • J02.9 Acute pharyngitis, unspecified
  • J06 Acute upper respiratory tract infections of multiple and unspecified localization
  • J11 Influenza, virus not identified
  • K00.7 Teething syndrome
  • K08.8.0* Toothache
  • M25.5 Joint pain
  • M79.1 Myalgia
  • M79.2 Neuralgia and neuritis, unspecified
  • R50 Fever of unknown origin
  • R51 Headache
  • T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of ​​the body
  • T14.9 Injury, unspecified
  • T88.1 Other complications associated with immunization, not elsewhere classified

pharmachologic effect

Antipyretic, analgesic, anti-inflammatory.

Blocks arachidonic acid cyclooxygenase and reduces PG synthesis. The antipyretic effect is due to a decrease in the concentration of PG in the cerebrospinal fluid, a decrease in excitation of the thermoregulation center, which results in the normalization of body temperature. The analgesic effect is associated with a decrease in the production of PG classes E, F, I, biogenic amines, a change in the sensitivity of nociceptors and the prevention of the development of hyperalgesia. The analgesic effect is most pronounced for inflammatory pain. The anti-inflammatory effect is due to a decrease in the secretion of inflammatory mediators and a decrease in the activity of the exudative and proliferative phase of the inflammatory process. The antipyretic and analgesic effect appears earlier and at lower doses than the anti-inflammatory effect, which occurs on days 5–7 of treatment.

Side effects

From the side of the central nervous system:

headache, dizziness, sleep disturbance, anxiety, drowsiness, depression, agitation, visual impairment (reversible toxic amblyopia, blurred vision or double vision).

From the hematopoietic organs:

heart failure, tachycardia, increased blood pressure; anemia, thrombocytopenia, agranulocytosis, leukopenia.

From the gastrointestinal tract:

nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, constipation, flatulence, liver dysfunction, peptic ulcers, gastric bleeding.

From the urinary system:

acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

Allergic reactions:

itching, rash, bronchospastic syndrome, allergic rhinitis, Quincke's edema, Steven-Johnson syndrome, Lyell's syndrome.

Contraindications

Hypersensitivity (including to acetylsalicylic acid or other NSAIDs), peptic ulcer of the stomach and duodenum, severe failure of the liver, kidneys, cardiovascular system, arterial hypertension, hemophilia, hypocoagulation, hemorrhagic diathesis, deficiency of glucose-6-phosphate dehydrogenase , bronchospastic reactions after the use of acetylsalicylic acid or other NSAIDs (“aspirin asthma”), Quincke’s edema, nasal polyps, hearing loss, infancy (up to 6 months, with body weight below 7 kg).

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