Index of drugs

Symptomatic treatment of fever and mild and moderate pain only in children from 3 months of age. above 5 kg to 12 years.

5 ml of suspension contains 100 mg ibuprofen. The preparation contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol.

A drug from the group of non-steroidal anti-inflammatory drugs (NSAIDs). The mechanism of action is based on inhibition of prostaglandin synthesis. Ibuprofen reduces pain, swelling and fever associated with inflammation. In addition, it reversibly inhibits platelet aggregation induced by ADP and collagen. After oral administration, it is partially absorbed in the stomach and then completely absorbed in the small intestine. The maximum concentration in blood serum occurs about 1-2 hours after administration. The drug is 99% bound to plasma proteins. It undergoes metabolism in the liver (hydroxylation, carboxylation) to the two main metabolites excreted mainly via the kidneys. T_0,5 in the elimination phase, it is about 2 hours.

Hypersensitivity to ibuprofen or to any of the excipients. Patients with a history of bronchospasm, asthma, or urticaria after using Acetylsalicylic acid or other NSAIDs. Active or recurrent peptic ulcer disease and / or gastric bleeding (2 or more different cases of proven ulceration or bleeding). Patients with a history of gastrointestinal bleeding or perforation associated with the use of NSAIDs. Severe hepatic failure, severe renal failure or severe heart failure or coronary heart disease. Third trimester of pregnancy. Unexplained hematopoietic disorders. Vascular cerebral hemorrhage or other active bleeding. Significant dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

Caution should be exercised when using NSAIDs in patients with a history of gastroenteritis (ulcerative colitis, Crohn's disease). The drug should be used with caution in patients with a history of gastrointestinal ulceration (especially complicated by bleeding or perforation) and in elderly patients. In these patients as well as in patients requiring simultaneous use of low-dose acetylsalicylic acid or other medications that increase the risk of gastrointestinal adverse reactions, consideration should be given to combination therapy with protective drugs (e.g., misoprostol or proton pump inhibitors). In patients with systemic lupus erythematosus and mixed connective tissue disease, there is an increased risk of aseptic meningitis. The product should be avoided concomitantly with other NSAIDs including selective COX-2 inhibitors. Caution should be exercised in patients receiving concomitant preparations that may increase the risk of ulceration or bleeding, e.g. oral corticosteroids, anticoagulants such as Warfarin or selective serotonin reuptake inhibitors, and antiplatelet agents such as acetylsalicylic acid. In the case of gastrointestinal bleeding or ulceration, the drug should be discontinued. In patients with reduced renal blood flow and reduced circulating blood volume, NSAIDs may cause symptoms of dose-related renal toxicity. Patients at risk are patients with impaired renal function, heart failure and impaired liver function. This is particularly important in patients with a history of hypertension and / or a history of impaired cardiac function, as kidney function and / or fluid retention may occur. Caution should be used in such patients. Caution should be exercised when using the preparation in patients with bronchial asthma or allergic diseases, as they may have NSAID-dependent asthma associated with severe bronchospasm. It is recommended to avoid the use of the preparation in cases of chickenpox.Patients who have coagulation disorders or use anticoagulant therapy should be carefully monitored (the drug may temporarily inhibit platelet function). Caution should be exercised in patients with congenital porphyrin metabolism (eg acute intermittent porphyria), dehydrated patients, patients immediately after major surgery. Do not use the product in children under 3 months (5 kg), due to insufficient clinical experience. It should not be used in patients with rare hereditary problems of fructose intolerance.

Do not use ibuprofen during the first and second trimesters of pregnancy, unless it is absolutely necessary. If ibuprofen is used by a woman who is trying to become pregnant, or by a pregnant woman in the first or second trimester of pregnancy, the lowest dose should be used and the therapy time should be kept to a minimum. In the third trimester of pregnancy, the preparation is contraindicated. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: toxic effects on the heart and lungs (with premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction that may worsen in kidney failure with oligohydramnios; mother and newborn in the final stage of pregnancy: possible prolongation of bleeding time, antiaggregation, which may occur even at very low doses, inhibition of uterine contractions causing delay and prolonged delivery. Ibuprofen is excreted in small amounts in the milk of nursing mothers and is unlikely to adversely affect a fed baby. However, if long-term therapy is recommended, discontinuation of breast-feeding should be considered. The use of ibuprofen may impair fertility and is not recommended for women trying to get pregnant. For women who have difficulty conceiving or who have fertility tests, discontinuation of ibuprofen should be considered.

Common: gastrointestinal complaints such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation and low blood loss from the gastrointestinal tract, which in exceptional cases can lead to anemia. Uncommon: hypersensitivity reactions with skin rash and pruritus, and asthma attacks (also with a decrease in blood pressure), disturbances o.u.n. (such as pain and dizziness, drowsiness, agitation, irritability or fatigue), visual disturbances, gastrointestinal ulceration, potentially bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis , rash, photosensitivity. Rare: tinnitus, damage to renal tissue (renal papillary necrosis), especially in the case of long-term therapy, increased serum uric acid, increased serum concentration of urea nitrogen, transaminases and alkaline phosphatase, decrease in hemoglobin and hematocrit, inhibition of platelet aggregation , prolonged bleeding time, decreased Calcium concentration, increased uric acid concentration. Very rare: exacerbation of inflammation associated with infection (eg, development of necrotizing fasciitis), symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or limitation of consciousness (especially patients with autoimmune diseases seem to be predisposed, eg : systemic lupus erythematosus, mixed connective tissue disease), hematopoietic disorders (anemia, leukopenia, trambocytopenia, aplastic anemia and agranulocytosis), increased generalized hypersensitivity reactions, psychotic reactions, depression, palpitations, heart failure, myocardial infarction, hypertension, inflammation esophagitis, pancreatitis, formation of diaphragmatic stenoses in the gut, hepatic impairment, liver damage, especially in the case of long-term therapy, hepatic failure, acute hepatitis, severe skin reactions, such as bullous episodes, including Stevens-Johnson syndrome, erythema multiforme and alopecia as a result of toxic epidermal necrolysis, decreased urinary excretion and formation of edema, in particular in patients with hypertension or renal failure, nephrotic syndrome, interstitial nephritis,which may be accompanied by acute renal failure. In exceptional cases, during chickenpox, severe skin infections and complications involving soft tissues may occur. Clinical trials and epidemiological data suggest that intake of ibuprofen (especially at high doses of 2400 mg / day) and long-term therapy may be associated with a small increase in the risk of arterial blockages (eg, myocardial infarction or stroke). Edema, hypertension and heart failure have been reported in relation to NSAID treatment.

Orally. The daily dose is 20-30 mg / kg. in divided doses. Infants 3-6 months (over 5 kg): 2.5 ml (50 mg) 3 times a day. Infants 6-12 months (8-10 kg): 2.5 ml (50 mg) 3 times a day. Children from 1 to 3 years (10-15 kg): 5 ml (100 mg) 3 times a day. Children from 4 to 6 years (15-20 kg): 7.5 ml (150 mg) 3 times a day. Children from 7 to 9 years (20-30 kg): 10 ml (200 mg) 3 times a day. Children from 10 to 12 years (30-40 kg): 15 ml (300 mg) 3 times a day. The doses should be administered every 6-8 h. If the symptoms do not disappear after 24 h in infants aged 3-6 months, and in children over 6 months, the symptoms last longer than 3 days, please contact your doctor. In patients with mild or moderate renal or hepatic impairment, the lowest effective dose should be used for the shortest duration necessary to relieve symptoms and to monitor renal or hepatic function.