Ibuprofen, 100 mg/5 ml suspension, 100 ml

Composition

Composition 100 ml of suspension: active substance:ibuprofen – 2 g;auxiliary components:dihydrate sodium phosphate – 0,46 g;propylene glycol – 1,71 g;parahydroxybenzoate – 0.05 g;citric acid monohydrate is 0.91 g;crospovidon – 0,14 g;sodium saccharin – 0.25 g;glycerol – 5.7 g;sodium carmellose – 0,97 g;methyl parahydroxybenzoate – 0,15 g;glycerylmonostearate macrogol – 1,14 g;sucrose is 34.2 g;magnesium aluminum silicate (Veegum) – 0,57 g;dye sunset yellow (E110) – 0.02 g;orange flavor – 0,34 g;purified water to 100 ml.

the Pharmacological action of

Ibuprofen, a nonsteroidal anti-inflammatory drug that is derived phenylpropionic acid.

It has anti-inflammatory, analgesic and antipyretic effects.

The effect of the drug is due to inhibition of prostaglandin synthesis by blocking the cyclooxygenase enzyme.

Inhibits platelet aggregation. With prolonged use, it has a desensitizing effect.

Indications

Ibuprofen for children is used from 6 months to 12 years as an antipyretic agent for acute respiratory diseases, flu, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by an increase in body temperature.

The drug is used as an analgesic for pain syndrome of mild or moderate intensity, including headache and toothache, migraines, neuralgia, pain in the ears and throat, pain with sprains and other types of pain.

Contraindications

Hypersensitivity, erosive and ulcerative diseases of the gastrointestinal tract (GIT) in the acute stage (including peptic ulcer of the stomach and duodenum, ulcerative colitis, Crohn’s disease), complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including in the anamnesis), blood clotting disorders (including hemophilia, prolonged bleeding time, tendency to bleed, hemorrhagic diathesis), active gastrointestinal bleeding; severe renal insufficiency (creatinine clearance less than 30 ml/min), progressive kidney disease, severe liver failure or active liver disease, condition after coronary artery bypass grafting, confirmed hyperkalemia, inflammatory bowel diseases, hereditary fructose intolerance due to the presence of sorbitol in the composition of the drug.

WITH CAUTION

Take for-cirrhosis of the liver with portal hypertension; hepatic and / or renal failure, heart failure, nephrotic syndrome, hyperbilirubinemia, peptic ulcer of the stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis, blood diseases of unknown etiology (leukopenia and anemia), pregnancy (II-III trimester), lactation. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study; during the treatment period, ethanol is not recommended; to reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used in the shortest possible course. In patients with asthma or other conditions associated with bronchospasm, Ibuprofen may increase the risk of bronchospasm. The use of the drug in these patients is permissible only if great care is taken, and in case of breathing difficulties, you should immediately consult a doctor.

Side effects

• from the digestive system: NSAID – gastropathy (nausea, vomiting, abdominal pain, heartburn, loss of appetite, diarrhea, bloating, pain and discomfort in the epigastric region), ulceration of the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding); irritation, dryness of the mucous membrane of the mouth or pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, constipation, hepatitis,
• respiratory system:shortness of breath, bronchospasm; from the sensory organs: hearing loss, ringing or tinnitus, reversible toxic neuritis of the optic nerve, blurred vision or diplopia, dry and irritated eyes, conjunctival and eyelid edema (allergic origin), scotoma;
• from the nervous system:headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely-aseptic meningitis (more often in patients with autoimmune diseases);
• from the cardiovascular system:development or aggravation of heart failure, tachycardia, increased blood pressure;
• from the urinary system:acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis; allergic reactions: skin rash (usually erythematous, urticaria), itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), eosinophilia, allergic rhinitis;
• organs of hematopoiesis:anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia; others: increased sweating; the risk of developing ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual disturbances (color vision disorders, scotoma, amblyopia) increases with prolonged use in large doses.

Interaction

Ibuprofen may reduce the diuretic effect of furosemide when administered concomitantly.

When used together, Ibuprofen enhances the effect of diphenin, coumarin-type anticoagulants, and oral hypoglycemic drugs.

How to take, course of administration and dosage

Set individually, depending on the nosological form of the disease, the severity of clinical manifestations. When taken orally or rectally for adults, a single dose is 200-800 mg, the frequency of administration is 3-4 times/day; for children-20-40 mg / kg/day in several doses.

Topically applied for 2-3 weeks.

The maximum daily dose for adults when taken orally or rectally is 2.4 g.

Overdose

Symptoms of ibuprofen overdose in children: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, apnea, acute renal failure, liver function disorders, tachycardia, bradycardia, atrial fibrillation, forced diuresis. Children under 5 years of age are particularly prone to sleep apnea, coma, and seizures.

Serious consequences associated with the toxic effect of the drug usually occur after taking a dose exceeding 400 mg/kg of body weight (i. e.80 recommended single doses). If an overdose is suspected, you should immediately consult a doctor.

Treatment for overdose: gastric lavage, taking activated charcoal, alkaline drinking, symptomatic therapy

Special instructions

During long-term use, nonsteroidal anti-inflammatory drugs can cause damage to the gastric mucosa, peptic ulcers and bleeding from the digestive tract. During long-term treatment with NSAIDs, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine Hb, hematocrit, and a fecal occult blood test.

Interaction with other medications Ibuprofen should not be used simultaneously with other nonsteroidal anti-inflammatory drugs (for example, acetylsalicylic acid reduces the anti-inflammatory effect of ibuprofen and increases the side effect). Concomitant administration of ibuprofen and diuretics should be avoided as much as possible, due to the weakening of the diuretic effect on the one hand and the risk of developing renal failure on the other. Ibuprofen weakens the effect of antihypertensive agents (angiotensin convertase inhibitors, – adrenergic agents, thiazides).

Inhibits the antihypertensive effect of ACE inhibitors, while reducing their excretion by the kidneys. Ibuprofen enhances the effect of oral hypoglycemic agents (especially sulfonylureas) and insulin. Inducers of microsomal oxidation phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic (antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions. Microsomal oxidation inhibitors-reduce the risk of hepatotoxic effects.

Increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increased risk of hemorrhagic complications). Increases the concentration of digoxin in the blood. Increases the toxic effect of methotrexate and lithium preparations. Caffeine enhances the analgesic effect.

Form of production

suspension for oral administration

Storage conditions

Store in a dry place, protected from light. Keep out of reach of children.

Expiration date

Shelf life is 2 years. Do not use after the expiration date.

Active ingredient

Ibuprofen

Dosage form

Oral suspension

Weight

Weight: 200 gr.