Ibuprofen FT oral suspension 200mg/5ml 100g №1

Name:
Ibuprofen FT susp.dpr.in. 200mg 5ml per vial 100g per pack No. 1
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Suspension of white or almost white color, viscous consistency, sweet taste with a specific smell of orange. Stratification of the suspension is allowed, which is eliminated by shaking. Main active ingredient Ibuprofen Form of release suspension Dosage 100 g Special instructions and precautions The likelihood of adverse reactions can be minimized by using the lowest effective dose for the shortest period of time necessary to eliminate symptoms (see below the risks in relation to the gastrointestinal tract and cardiovascular system ). Elderly IBUPROFEN FT should be used with caution in the elderly, because they noted an increased incidence of adverse reactions during the use of NSAIDs, especially from the gastrointestinal tract (gastrointestinal bleeding, ulcers, perforations, which can be fatal). Respiratory system Patients with bronchial asthma or allergic diseases (including history) may develop bronchospasm. Other NSAIDs The simultaneous use of IBUPROFEN FT suspension and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided (see section “Interaction with other medicinal products and other forms of interaction”). Systemic lupus erythematosus and mixed connective tissue disease Systemic lupus erythematosus and mixed connective tissue disease contribute to an increased risk of aseptic meningitis (see section “Side effects”). Cardiovascular and cerebrovascular effects IBUPROFEN FT should be used with caution in patients with heart failure, arterial hypertension (since fluid retention, hypertension and edema have been reported in connection with the use of NSAIDs). The use of ibuprofen (especially at high doses of 2400 mg / day and for a long time) may be associated with a slight increase in the risk of developing pathologies caused by arterial thrombosis (eg, myocardial infarction, stroke). In general, data from epidemiological studies do not indicate that ibuprofen, when used at doses of ?1200 mg / day, may increase the risk of myocardial infarction. Effects on the kidneys Ibuprofen should be used with caution in patients with impaired renal function, as these disorders may be aggravated by the use of ibuprofen. There is a risk of developing impaired renal function in children with dehydration (see sections “Contraindications” and “Side Effects”). Effects on the liver Ibuprofen should be used with caution in patients with liver dysfunction (see sections “Contraindications” and “Side Effects”). Influence on the gastrointestinal tract Patients with diseases of the gastrointestinal tract (ulcerative colitis, Crohn’s disease) should be prescribed NSAIDs with caution due to the possible exacerbation of these diseases (see section “Side Effects”). Gastrointestinal bleeding, ulcers, perforations (including fatalities) have been reported with all NSAIDs at any time from the start of their use with or without previous symptoms and with or without severe gastrointestinal pathology. in history. The risk of bleeding, development of ulcers, perforations increases with an increase in the dose of NSAIDs; also, this risk is higher in patients with a history of ulcers, especially those complicated by bleeding or perforation (see section “Contraindications”), and in the elderly. These patients should start the use of ibuprofen with minimal doses. Patients with a history of gastrointestinal pathology, especially elderly patients, should report any unusual gastrointestinal symptom (in particular, signs of gastrointestinal bleeding), especially occurring at the initial stage of taking the drug. If patients develop an ulcer or gastrointestinal bleeding while taking ibuprofen, the drug should be stopped immediately. When symptoms of gastropathy appear, careful monitoring of the patient’s condition is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), fecal occult blood analysis. Caution should be observed in patients taking concomitant medicinal products that may increase the risk of ulcers or bleeding in the gastrointestinal tract, such as oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors, antiplatelet agents (acetylsalicylic acid) (see section “Interaction with other drugs and other forms of interaction”). Effects on blood coagulation IBUPROFEN FT may temporarily inhibit platelet function. In this regard, patients with bleeding disorders should be carefully examined. The results of experimental studies show a weakening of the action of acetylsalicylic acid as an inhibitor of platelet aggregation when used simultaneously with ibuprofen. Skin reactions There are very rare reports of the development of severe skin reactions, sometimes fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in connection with the use of NSAIDs (see section “Side effect”). It is likely that patients are most at risk of developing such reactions at the start of NSAID use: in most cases, these skin reactions began to develop during the first month of therapy. Ibuprofen should be discontinued immediately at the first sign of a skin rash, mucosal damage, or any other symptoms of hypersensitivity. In exceptional cases, chickenpox can lead to severe infectious complications of the skin and soft tissues. At the moment, a certain contribution of NSAIDs to the worsening of the course of this infection cannot be excluded. Therefore, it is desirable to avoid the use of ibuprofen in chickenpox. Impaired fertility in women There is limited evidence that drugs that inhibit prostaglandin synthesis, which occurs with the participation of the enzyme cyclooxygenase, can cause impaired fertility in women through an effect on ovulation. This effect is reversible upon discontinuation of the drug. Excipients 5 ml of IBUPROFEN FT suspension contains 1 g of sugar (0.1 XE), which must be taken into account in patients with diabetes mellitus. The medicinal product contains white crystalline sugar. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency should not take IBUPROFEN FT. A preliminary consultation with a doctor is required. The medicinal product contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, which may cause allergic reactions. Indications for use Decrease in body temperature during fever, including post-vaccination. Relief of cold and flu symptoms. Treatment of pain syndrome from mild to moderate intensity (pain in the throat, pain during teething, toothache, earache, headache, pain with minor injuries and sprains of the ligaments and muscles. Dosage and administration The drug is intended for oral administration. 5 ml of suspension contains 100 mg or 200 mg of ibuprofen Shake before use until a homogeneous suspension is obtained The drug is taken after meals with liquid The measuring cup with a scale attached to the package allows you to accurately dose the drug The dose is set depending on the age and body weight of the child (see table below).The likelihood of adverse reactions can be minimized by using the lowest effective dose for the shortest period of time necessary to eliminate symptoms (see section “Special instructions and precautions”). The drug is intended for short-term use only. applications . The recommended daily dose of the drug IBUPROFEN FT is 20-30 mg/kg of the child’s body weight, divided into several equal doses for several doses during the day. It is not allowed to exceed the maximum daily dose. Recommendations for dosing regimen are presented in the table. Application during pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and the development of the embryo and fetus. Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. It is likely that the risk increases as the dose and duration of drug use increase. The use of ibuprofen in the first 6 months of pregnancy is allowed only on prescription after a careful assessment of the ratio of the intended benefit to the mother and potential risks to the embryo / fetus. The use of ibuprofen in the last trimester of pregnancy is contraindicated. Taking inhibitors of prostaglandin synthesis during the third trimester of pregnancy can cause the development of toxic effects on the cardiovascular and respiratory systems of the fetus (premature closure of the ductus arteriosus, pulmonary hypertension), impaired fetal kidney function (up to the development of renal failure with oligohydramnios), increase in time bleeding in the mother and newborn (an antiplatelet effect can be observed even after using very low doses), inhibition of uterine contractions (which can lead to a delay in the onset of labor or make them protracted). Lactation According to limited data, very low concentrations of ibuprofen have been found in breast milk. There are no known cases of adverse reactions in infants, but it is recommended to stop breastfeeding during treatment with ibuprofen. Interaction with other drugs The simultaneous use of ibuprofen and the following drugs should be avoided. Acetylsalicylic acid (aspirin) Except when low doses of acetylsalicylic acid (no more than 75 mg / day) are prescribed by the attending physician, the simultaneous use of acetylsalicylic acid should be avoided, as this may increase the risk of adverse reactions (see section “Special instructions and precautions). Experimental data indicate that ibuprofen may inhibit the effect of low doses of acetylsalicylic acid (aspirin) on platelet aggregation when these drugs are co-administered. However, the limitations of these data and the uncertainty about the possibility of extrapolating ex vivo data to clinical situations mean that it is impossible to draw firm conclusions and make recommendations regarding regular long-term use of ibuprofen; the possibility that ibuprofen with regular long-term use may reduce the cardioprotective effect of acetylsalicylic acid when used in low doses cannot be ruled out. It is believed that the development of clinically significant effects is unlikely with short-term use of ibuprofen. Other NSAIDs, including selective cyclooxygenase-2 inhibitors The simultaneous use of 2 or more NSAIDs should be avoided, as this may increase the risk of adverse reactions (see section “Special instructions and precautions”). Caution must be exercised when ibuprofen is used concomitantly with the following medicinal products. Anticoagulants NSAIDs may enhance the effects of anticoagulants such as warfarin (see section “Special instructions and precautions”). Diuretics, ACE inhibitors, beta-blockers and angiotensin II receptor antagonists NSAIDs may reduce the effect of diuretics and other antihypertensive agents. Diuretics may increase the risk of NSAID nephrotoxicity. Lithium, methotrexate Simultaneous use with methotrexate or lithium-based drugs may increase the concentration of these drugs in the blood plasma. Cardiac glycosides NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma glycoside levels. Cyclosporine Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects, and also increases the risk of nephrotoxicity. Tacrolimus With simultaneous administration increases the risk of nephrotoxicity. Corticosteroids Ibuprofen increases the risk of ulcers and gastrointestinal bleeding (see section “Special instructions and precautions”). Antiplatelet agents and selective serotonin reuptake inhibitors Increased risk of gastrointestinal bleeding (see section “Special instructions and precautions”). Zidovudine When used simultaneously with NSAIDs, the risk of hematotoxicity increases. There is a possibility of an increased risk of hemarthrosis and hematomas and HIV-positive people with hemophilia taking zidovudine and ibuprofen at the same time. Quinolone antibiotics Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking both NSAIDs and quinolones are likely to be at an increased risk of developing seizures. Mifepristone NSAIDs should not be used within 8 to 12 days of mifepristone use as NSAIDs may reduce the effect of mifepristone. Contraindications Known individual hypersensitivity to ibuprofen or other NSAIDs (including acetylsalicylic acid), as well as to auxiliary components of the finished dosage form. Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history). Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, ulcerative colitis, peptic ulcer, Crohn’s disease). Bleeding or perforation in the gastrointestinal tract in history, associated with the use of NSAIDs. Severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease. Severe liver failure or active liver disease. Severe heart failure. Confirmed hyperkalemia. Inflammatory bowel disease. philia, prolongation of bleeding time, tendency to bleeding, hemorrhagic diathesis). Children’s age up to 3 months. Last trimester of pregnancy (see. section “Fertility, pregnancy and lactation”). With caution: cirrhosis of the liver with portal hypertension; hepatic and / or renal failure; arterial hypertension, chronic heart failure; nephrotic syndrome; hyperbilirubinemia; presence of H. pylori infection; peptic ulcer of the stomach and duodenum (in history); gastritis; enteritis; colitis; blood diseases of unknown etiology (leukopenia and anemia); prolonged use of NSAIDs; severe somatic diseases; simultaneous administration of oral glucocorticosteroids (including prednisolone); anticoagulants (including warfarin); antiplatelet agents (including clopidogrel). The composition of the 5.0 ml suspension contains 100 mg or 200 mg of ibuprofen as an active ingredient. Excipients: white crystalline sugar, glycerin, propylene glycol, macrogolglycerol hydroxystearate, citric acid monohydrate, sodium carboxymethylcellulose, anhydrous colloidal silicon dioxide, sodium dihydrogen phosphate dihydrate, Orange PX1488 flavor, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. OverdoseSymptoms Possible symptoms of overdose: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, lowering blood pressure, convulsions, respiratory arrest, acute renal failure, abnormal liver function , tachycardia, bradycardia, atrial fibrillation. Children under 5 are especially prone to sleep apnea, coma, and seizures. Serious effects associated with the toxic effect of the drug usually appear after taking a dose exceeding 400 mg / kg of body weight. Also, in case of an overdose, it must be taken into account that the drug contains the excipient propylene glycol. Propylene glycol, when used in large volumes, has an intoxicating effect that is three times less pronounced than that of ethanol. Side effects in case of overdose are most often manifested by the central nervous system, especially in newborns. Other single adverse reactions include ototoxicity, cardiovascular effects (hypotension), convulsions. Hyperosmolarity and lactic acidosis are most common in patients with renal insufficiency. Side effects are more common when large amounts of propylene glycol are consumed or used in newborns, children under 4 years of age, pregnant women, and patients with hepatic or renal insufficiency. Disulfiram-like reactions may also occur in patients receiving concomitant disulfiram or metronidazole. In case of overdose, you should immediately consult a doctor. Treatment Gastric lavage (only within an hour after taking the drug), activated charcoal, alkaline drink, symptomatic therapy (correction of the acid-base state, blood pressure). Side effects Undesirable reactions that may occur when using ibuprofen are classified by frequency of occurrence and by organ systems. The frequency of occurrence of adverse reactions is estimated according to the following scheme: very often (? 1/10); often (?1/100 to <1/10); infrequently (?1/1000 to <1/100); rarely (?1/10000 to <1/1000); very rarely (<1/10000); frequency unknown (frequency cannot be determined from available data). When using the drug IBUPROFEN FT for 2-3 days, adverse reactions are practically not observed. In the case of longer use, the following adverse reactions may occur. Infectious and parasitic diseases: very rarely - an exacerbation of the inflammatory process caused by an infection (for example, the development of necrotizing fasciitis), in exceptional cases, severe infectious complications from the skin and soft tissues with chickenpox may occur. Immune system disorders: infrequently - hypersensitivity reactions, which can be divided into: - non-specific allergic reactions, anaphylaxis; - reactions of the respiratory tract, for example, asthma, exacerbation of asthma, bronchospasm, shortness of breath; - various skin reactions, for example, itching, urticaria, Quincke's edema, purpura, less often exfoliative and bullous dermatosis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme). Gastrointestinal disorders; infrequently - abdominal pain, nausea, dyspepsia; rarely - diarrhea, flatulence, constipation, vomiting; very rarely - ulceration of the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding, followed by chalking or vomiting of blood), dryness of the oral mucosa, aphthous stomatitis, exacerbation of colitis and Crohn's disease, pancreatitis, gastritis. Liver and biliary tract disorders: very rarely - liver dysfunction, hepatitis. Nervous system disorders: infrequently - headache, dizziness, insomnia, psychomotor agitation, irritability or fatigue; very rarely - aseptic meningitis (more often in patients with autoimmune diseases). On the part of the organ of vision: infrequently - visual disturbances (blurred vision or diplopia), dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis). On the part of the organ of hearing and labyrinth disorders: rarely - hearing loss, ringing or noise in the ears. Blood and lymphatic system disorders: very rarely - anemia (including hemolytic, aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia. Cardiac disorders: very rarely - development or worsening of heart failure, palpitations. The use of ibuprofen (especially at high doses of 2400 mg / day and for a long time) may be associated with a slight increase in the risk of developing pathologies caused by arterial thrombosis (eg, myocardial infarction, stroke). Vascular disorders: very rarely - increased blood pressure. The use of ibuprofen (especially at high doses of 2400 mg / day and for a long time) may be associated with a slight increase in the risk of developing pathologies caused by arterial thrombosis (eg, myocardial infarction, stroke). Renal and urinary tract disorders: very rarely - nephrotic syndrome (edema), acute renal failure, papillary necrosis, polyuria, increased serum urea concentrations, interstitial nephritis. Skin and subcutaneous tissue disorders: infrequently - skin rash; very rarely - alopecia; frequency unknown - drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Influence on the results of laboratory and instrumental studies: very rarely - a decrease in hemoglobin levels. Reporting suspected adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions through the national adverse reaction reporting system. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children! 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