Fever of various origins (also in the course of viral infections, in the course of vaccination). Pains of various origins of weak to moderate severity: headache, throat and muscle pain (eg in the course of viral infections); pain in the muscles, joints and bones, as a result of injuries to the musculoskeletal system (strains, sprains); pain due to soft tissue injuries, postoperative pain; toothache, pain after tooth extraction, pain due to serration; Headache; ear pain that occurs in inflammations of the middle ear.
Composition:
5 ml oral suspension contains 100 mg or 200 mg (forte) of ibuprofen.
Action:
A non-steroidal antipyretic drug, analgesic and anti-inflammatory. The mechanism of anti-inflammatory action consists in inhibiting the activity of prostaglandin cyclooxygenase. It is rapidly absorbed from the digestive tract and reaches Cmax about 1-2 h after administration (food delays the absorption of Ibuprofen, but does not reduce its bioavailability). It is more than 99% bound to plasma proteins. It is metabolized in the liver and excreted mainly in the urine in the form of metabolites. T0,5 is about 2 hours.
Contraindications:
Hypersensitivity to Ibuprofen or to other NSAIDs or any of the excipients. Presence of allergy symptoms in the form of rhinitis, urticaria or bronchial asthma in the past after taking 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. Severe hepatic failure. Severe renal failure. Severe heart failure. Concomitant use of other NSAIDs, including COX-2 inhibitors (increased risk of side effects). Bleeding from cerebral vessels or other active bleeding. Hemorrhagic diathesis or unexplained hematopoietic disorders. Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Third trimester of pregnancy. In addition, forte is contraindicated in children weighing <5 kg.
Precautions:
Caution in patients with: systemic lupus erythematosus and mixed connective tissue disease (risk of steroid inflammation of the meninges); congenital disorder of porphyrin metabolism (e.g., acute reversible porphyria); diseases of the gastrointestinal tract and chronic inflammatory bowel diseases - ulcerative colitis, Crohn's disease (risk of exacerbation of these diseases); hypertension and / or cardiac dysfunction (risk of worsening kidney function, edema); impaired renal function; impaired liver function; impaired blood coagulation (ibuprofen may prolong the bleeding time); immediately after a major surgery; with active or past bronchial asthma, chronic obstructive pulmonary disease, hay fever, nasal polyps or hypersensitivity to other substances (increased risk of allergic reactions, including bronchospasm); in the elderly (increased risk of side effects). In addition, patients with uncontrolled hypertension, congestive heart failure, known ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease and risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes, smoking) should be treated ibuprofen after careful consideration. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dosages, in patients with a history of ulceration (especially complicated hemorrhage or perforation), in the elderly and in patients taking other medicines at the same time that may increase the risk of stomach disorders and intestinal or haemorrhage (such as corticosteroids, anticoagulants, anti-aggregation agents, including ASA) - the lowest effective dose of ibuprofen should be used in these patient groups for the shortest time; combination with protective drugs (eg misoprostol or proton pump inhibitors) should be considered.In the event of a gastrointestinal haemorrhage or ulcer, the preparation should be discontinued immediately. Discontinue treatment after the first signs of hypersensitivity, such as skin rash and mucous membrane damage. The use of ibuprofen in the case of chickenpox should be avoided (risk of serious complications of skin and soft tissue). Ibuprofen may mask the symptoms of infection and fever. During long-term use, check blood count indicators and kidney and liver function at regular intervals. As a result of long-term use of painkillers, headaches may occur which should not be treated with increased doses of this medicine. Individual cases of toxic ambliopathy have been reported with ibuprofen, therefore any visual disturbances should be carefully monitored. Concomitant, long-term use of various painkillers may lead to kidney damage with the risk of renal failure (resolved nephropathy). The medicine contains: sodium benzoate - therefore it should be used with caution in patients with hypersensitivity, in particular children with atopic changes, asthma; maltitol - therefore it should not be used in patients with fructose intolerance; sodium - this should be taken into account in patients with reduced renal function and in patients who control sodium content in the diet.
Pregnancy and lactation:
Ibuprofen should not be used during the first and second trimesters of pregnancy, unless it is absolutely necessary. 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. Interruption of feeding is not necessary with short-term use of ibuprofen at the recommended doses, for analgesic and antipyretic purposes. Ibuprofen may affect fertility in women by affecting ovulation; this effect is transient and disappears after completion of therapy.
Side effects:
Adverse effects observed during treatment with ibuprofen, also those occurring after long-term therapy with high doses, used in patients with rheumatic disease. These incidence rates, which go beyond very rare reports, refer to the short-term use of daily doses up to a maximum oral dose of 1,200 mg ibuprofen and up to a maximum dose of 1,800 mg in the form of rectal suppositories. Common: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, slight bleeding from the gastrointestinal tract (which may lead to anemia in exceptional cases). Uncommon: hypersensitivity reactions (skin rash, urticaria, pruritus, as well as bouts of breathlessness - possible occurrence in combination with lowering of blood pressure), headache, dizziness, insomnia, agitation, irritability, fatigue, visual disturbances, gastrointestinal ulcers (potentially with bleeding and perforation), ulcerative oral mucositis, exacerbation of colitis and Crohn's disease, gastritis. Rare: tinnitus, renal papillary necrosis, increased uric acid in the blood. Very rare: tarry stools, bloody vomiting, exacerbation associated with infection of inflammation (eg necrotizing fasciitis), symptoms of aseptic meningitis in patients with autoimmune diseases, anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, severe, generalized hypersensitivity reactions (swelling of the face, swelling of the tongue, laryngeal internal swelling with impaired airway obstruction, respiratory failure, increased heart rate, lowering of blood pressure, and life-threatening shock), asthma exacerbation, bronchospasm, psychotic reactions, depression, palpitations, heart failure, myocardial infarction, stroke, hypertension, oesophagitis, pancreatitis,formation of diaphragmatic stenosis, liver dysfunction, liver damage (in particular after long-term treatment), hepatic failure, acute hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, severe skin infections and soft tissue complications patients infected with chickenpox, edema (especially in patients with hypertension or renal failure), decreased urine output, sodium retention, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. The use of ibuprofen, especially at high doses (2,400 mg / day) for a long time may be associated with a small increase in the risk of arterial blockages (eg myocardial infarction or stroke); however, epidemiological studies do not indicate that taking low doses of ibuprofen (<1,200 mg per day) is associated with an increased risk of heart attack.
Dosage:
Oral: 20-30 mg ibuprofen / kg / day, in divided doses. You should keep at least a 6-hour break between each dose.Preparation 100 mg / 5 ml (Ibufen D, Ibufen for children with a raspberry or strawberry flavor). Infants from 3 to 6 months (5-7,6 kg): 2.5 ml 3 times daily (150 mg / day). Infants from 6 to 12 months (7.7-9 kg): 2.5 ml 3-4 times a day (150-200 mg / day). Children 1-3 years (10-15 kg): 5 ml 3 times a day (300 mg / day). Children 4-6 years (16-20 kg): 7.5 ml 3 times a day (450 mg / day). Children 7-9 years (21-29 kg): 10 ml 3 times a day (600 mg / day). Children 10-12 years (30-40 kg): 15 ml 3 times a day (900 mg / day).Forte 200 mg / 5 ml (Ibufen for forte children with a raspberry or strawberry flavor). Infants from 3 to 6 months (5-7,6 kg): 1.25 ml 3 times a day (150 mg / day). Infants from 6 to 12 months (7.7-9 kg): 1.25 ml 3-4 times a day (150-200 mg / day). Children 1-2 years (10-12 kg): 2.5 ml 3 times a day (300 mg / day). Children 3-5 years (13-19 kg): 2.5 ml 4 times a day (400 mg / day). Children 6-9 years (20-29 kg): 5 ml 3 times a day (600 mg / day). Children 10-12 years (30-40 kg): 5 ml 4 times a day (800 mg / day). Children from 12 years, adolescents, adults (> 40 kg): 5-10 ml 3 times a day (1200 mg / day).Special groups of patients. In patients with mild or moderate renal or hepatic impairment as well as in the elderly, dose adjustment is not required.Method of administration. The drug is given after meals, with lots of fluids.