Fever of various origins (including in the course of viral infections and vaccination reaction). Pains of various origins of weak to moderate severity: headaches, throats and muscles eg in the course of viral infections; aching muscles, joints and bones, due to injuries of the motor organs (strains, sprains); pain due to soft tissue injuries, postoperative pain; toothache, pain after dental procedures, pain due to serration; headaches; ear pains occurring in inflammations of the middle ear.
Composition:
5 ml of suspension contains 100 mg ibuprofen. The drug contains sucrose and sunset yellow (E 110).
Action:
Ibuprofen (a propionic acid derivative) belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). The mechanism of action is based on inhibition of prostaglandin synthesis. Ibuprofen reduces pain caused by inflammation, swelling and fever. In addition, it reversibly inhibits platelet aggregation. Analgesic and antipyretic effects begin within 30 minutes of taking the preparation. Ibuprofen is absorbed quickly and is rapidly distributed in the body. Cmax in serum occurs within 1-2 h after administration on an empty stomach. Ibuprofen and its metabolites are excreted completely and rapidly by the kidneys. T0,5 is about 2 hours.
Contraindications:
Hypersensitivity to Ibuprofen, other NSAIDs or to any of the excipients. Past hypersensitivity reactions, such as bronchial asthma, rhinitis or urticaria caused by the administration of salicylates (including acetylsalicylic acid) or other NSAIDs. Peptic ulcer of the stomach and / or duodenum, active or in history, perforation or bleeding, also those occurring after the use of NSAIDs. Concomitant use of other NSAIDs, including COX-2 inhibitors. Hemorrhagic diathesis. Severe hepatic failure. Severe renal failure. Severe heart failure. Third trimester of pregnancy.
Precautions:
Caution should be exercised when using the drug in patients with: systemic lupus erythematosus and mixed connective tissue disease - due to an increased risk of developing aseptic meningitis; gastrointestinal disease, especially chronic inflammatory bowel disease (ulcerative colitis, Leśniowski-Crohn's disease) - exacerbation of the disease may occur; hypertension and / or cardiac dysfunction also in a history of fluid retention and edema associated with NSAIDs; impaired renal function - the risk of further deterioration of renal function; hepatic impairment; blood coagulation disorders (ibuprofen may prolong the bleeding time). Taking the medicine in the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. In patients with active or past bronchial asthma and allergic diseases, taking the drug may cause bronchospasm. In elderly patients, the risk of side effects due to the use of the drug is higher than in younger patients. There is a risk of gastrointestinal haemorrhage, ulceration or perforation that can be fatal and which may not necessarily be preceded by warning signs or may occur in patients who have these warning signs. In case of a gastrointestinal haemorrhage or ulcer, the drug should be immediately discontinued. Patients with a history of a history of gastrointestinal tract, especially in the elderly, should be advised that the doctor should be informed of any unusual symptoms of the digestive system (especially bleeding), especially in the initial phase of therapy. These patients should use the lowest effective dose of the medicine. Caution should be exercised in patients who are also taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulants (eg Warfarin, acenocoumarol), anti-aggregation agents (eg acetylsalicylic acid).The intake of ibuprofen, especially at high doses (2,400 mg / day) over a long period of time may be associated with a small increase in the risk of arterial blockages (e.g., myocardial infarction or stroke). Epidemiological studies do not indicate that taking low doses (eg 1200 mg per day) is associated with an increased risk of heart attack. Patients with untreated hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease or cerebrovascular disease should be treated with ibuprofen with caution. Similarly, caution should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes, or smoking). Concomitant, long-term use of various painkillers may lead to kidney damage with the risk of renal failure (resolved nephropathy). The drug should be used with caution in patients with impaired renal, hepatic or cardiac function due to the possibility of deterioration of renal function. In these patients, monitoring of renal function is recommended. Due to the risk of severe skin reactions, the drug should be discontinued after the first symptoms, such as skin rash or other signs of hypersensitivity. The use of ibuprofen in patients with chickenpox should be avoided. NSAIDs may mask the symptoms of infection and fever. In case of blurred vision, the patient should consult an ophthalmologist. The product contains sucrose - should not be used in patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. The preparation contains an orange yellow which may cause allergic reactions.
Pregnancy and lactation:
Ibuprofen can be used in the first and second trimester of pregnancy only if there is a definite necessity (risk of miscarriage and the occurrence of congenital heart defects and gastrosharing due to the use of a prostaglandin synthesis inhibitor in early pregnancy, the risk increases with the dose and duration of treatment). If ibuprofen is to be used in women planning pregnancy or in the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. In the third trimester, the use of ibuprofen is contraindicated. Ibuprofen used in the third trimester of pregnancy may cause pulmonary hypertension, premature closure of the ductus arteriosus and renal dysfunction, which may be converted into renal failure with oligohydramnios; in the mother - suppress the uterine contractile function; in the mother and in the fetus an anti-aggregation effect may be manifested by the prolongation of coagulation time. Ibuprofen and its metabolites can penetrate into breast milk in very small amounts. Interruption of feeding is not necessary with short-term use of ibuprofen in doses used to treat pain and fever. The use of ibuprofen may reduce fertility in women and it is not recommended for women who are planning pregnancy. For women who have difficulty conceiving or who are being tested for infertility, discontinuation should be considered.
Side effects:
Uncommon: indigestion, abdominal pain, nausea, epigastric pain, abdominal cramps, epigastric discomfort, heartburn, headache, scotoma, blurred vision, diplopia, color vision disorders, urticaria and pruritus. Rare: diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, fatigue, edema. Very rare: tarry stools, bloody vomiting, ulcerative oral mucositis, exacerbation of colitis and Crohn's disease, aseptic meningitis, disturbances of consciousness, depression, emotional disturbances, tinnitus, impaired hearing, azotemia, hematuria, renal failure (including acute renal failure), renal papillary necrosis, decreased creatinine clearance, polyuria, decreased urine output, increased sodium in the blood (sodium retention), liver dysfunction, liver damage (especially during long-term use), hematological disorders - anemia , leukopenia, thrombocytopenia, pancytopenia, agranulocytosis (first symptoms are fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, bleeding, e.g.bruises, ecchymosis, purpura, nosebleeds); erythema multiforme, Stevens-Johnson syndrome, toxic necrotizing fissures, severe hypersensitivity reactions such as swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension, shock), asthma exacerbation, bronchospasm, edema, hypertension and heart failure (associated with use of NSAIDs in high doses), aseptic meningitis (mainly in patients with autoimmune disease, e.g. systemic lupus erythematosus and related connective tissue diseases). In exceptional cases, severe infections of the skin and complications of soft tissues may occur during infection with chickenpox. Gastric ulcer, perforation or gastrointestinal bleeding may occur, sometimes with fatal outcome, especially in elderly patients. Clinical trials and epidemiological data suggest that intake of ibuprofen, especially long-term at high doses (2,400 mg / day) may be associated with a small increase in the risk of arterial emboli (eg myocardial infarction or stroke). Additional side effects may occur during long-term therapy with high doses.
Dosage:
Orally. The maximum daily dose is 20-30 mg / kg, in divided doses, according to the following scheme: infants from 3 to 6 months old. (m. 5-7,6 kg): 2.5 ml 3 times a day; infants from 6 to 12 months (body weight: 7.7-9 kg): 2.5 ml 3-4 times a day; children from 1 to 3 years (10-15 kg): 5 ml 3 times a day; children from 4 to 6 years (16-20 kg): 7.5 ml 3 times a day; children from 7 to 9 years (body weight: 21-29 kg): 10 ml 3 times a day; children from 10 to 12 years (30-40 kg): 15 ml 3 times a day. Children <6 months drug can be given only in consultation with a doctor. Do not use it for more than 3 days without consulting your doctor.