Nurofen suspension 100mg 5ml strawberry 150ml
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Active ingredients
Ibuprofen
Release form
Suspension
Composition
Suspension for oral administration syrupy consistency, with a characteristic strawberry odor. 5 ml contains 100 mg of ibuprofen. Auxiliary substances: polysorbate 80 - 0.5 mg, glycerol - 0.5 mg, maltitol syrup - 1.625 mg, sodium saccharinate - 10 mg, citric acid - 20 mg, sodium citrate - 25.45 mg, xanthan gum - 37.5 mg, sodium chloride - 5.5 mg, domiphen bromide - 0.5 mg, strawberry flavoring 500244E - 12.5 mg, purified water - up to 5 ml
Pharmacological effect
Ibuprofen is a NSAID, a derivative of propionic acid, which has demonstrated its effectiveness by suppressing the synthesis of prostaglandins - mediators of pain and inflammation. Ibuprofen has an analgesic, antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation
Pharmacokinetics
Analgesic dose for children is 7-10 mg / kg of body weight when using the maximum dose of 30 mg / kg / day. Nurofen for children begins to act after 15 minutes, and reduces the body temperature in children up to 8 hours. Ibuprofen is 90–99% bound to plasma proteins and penetrates into the synovial fluid. Ibuprofen is metabolized in the liver to two inactive metabolites, which are quickly and almost completely excreted by the kidneys. Some amount (10%) is displayed in unchanged form. T1 / 2 is 2 hours.
Indications
Symptomatic treatment of fever and pain of various origins in children aged 3 months to 12 years old with a body weight of at least 5 kg (including fever after immunization, SARS, flu, teething pain, pain after tooth extraction, toothache, headache , sore throat, pain during sprains and other types of pain, including inflammatory origin)
Contraindications
A complete or incomplete combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs; - bleeding or perforation of the gastrointestinal ulcer in history, provoked by the use of NSAIDs; - erosive and ulcerative diseases of the gastrointestinal or more confirmed episodes of peptic ulcer or ulcerativebleeding); - severe liver failure or liver disease in the active phase; - severe renal failure (CK <30 ml / min); - confirmed hyperkalemia; - decompensated heart failure; - period after coronary artery bypass surgery; - cerebrovascular or other bleeding; - hemophilia and other bleeding disorders (including hypocoagulation); - hemorrhagic diathesis; - III trimester of pregnancy; - fructose intolerance; - baby body weight up to 5 kg; - hypersensitivity to ibuprofen or any of the components that make up the drug. Kazan for severe liver failure or liver disease in the active phase. With caution should be used for liver failure. Use for renal dysfunction. Contraindicated for severe renal failure (CK <30 ml / min). With caution, a drug of renal failure should be prescribed, including with dehydration (CC 30-60 ml / min), fluid retention and edema
Precautionary measures
Precautions should be prescribed with the simultaneous use of other NSAIDs; history of a single episode of gastric ulcer or gastric ulcer bleeding, gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the anamnesis (the development of bronchospasm is possible); severe somatic diseases; systemic lupus erythematosus or mixed connective tissue disease (Sharpe syndrome) - an increased risk of aseptic meningitis; renal failure, incl. with dehydration (CC 30-60 ml / min), fluid retention and edema; liver failure; hypertension and / or heart failure; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral artery diseases; blood diseases of unknown etiology (leukopenia, anemia); simultaneous use of other drugs that may increase the risk of ulcers or bleeding, in particular, GCS for oral administration (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (in t. hCitalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); in the first and second trimester of pregnancy, in the period of breastfeeding, elderly patients
Use during pregnancy and lactation
Use of the drug in the III trimester of pregnancy is contraindicated. Before using the drug in the I and II trimesters of pregnancy or during breastfeeding should consult a doctor. There is evidence that small amounts of ibuprofen can penetrate into breast milk without any negative consequences for the health of the infant.
Dosage and administration
The drug is intended only for short-term use. The drug is taken orally. Patients with hypersensitivity of the stomach are advised to take the drug with meals. The dose depends on the age and body weight of the child. With fever and pain syndrome, the maximum daily dose should not exceed 30 mg / kg body weight with intervals between doses of the drug 6-8 hours. Age 3-6 months, body weight 5 kg-7.6 kg, dosing regimen of 50 mg ) 3 times / day., The maximum daily dose of 150 mg (7.5 ml). Age 6-12 months., Body weight 7.7-9 kg, 50 mg (2.5 ml) 3-4 times / day, maximum daily dose 200 mg (10 ml). Age 1-3 years, body weight 10-16 kg, 100 mg (5 ml) 3 times / day, maximum daily dose of 300 mg (15 ml). Age 4-6 years, body weight 17-20 kg, 150 mg (7.5 ml) 3 times / day. , the maximum daily dose of 450 mg (22.5 ml). Age 7-9 years, body weight 21-30 kg, 200 mg (10 ml) 3 times / day., The maximum daily dose of 600 mg (30 ml). Age 10- 12 years, body weight 31-40 kg, 300 mg (15 ml) 3 times / day., The maximum daily dose of 900 mg (45 ml). Do not exceed the specified dose. The duration of treatment is not more e 3 days. If using the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), the symptoms persist or worsen, it is necessary to stop treatment and consult a doctor. For fever after immunization in children under the age of 6 months, the drug is administered at a dose of 50 mg (2.5 ml); if necessary, after 6 h, the drug can be reappointed in the same dose. Do not use more than 100 mg (5 ml) within 24 hours. The rules for using a measuring syringe The suspension before use should be carefully shaken. For accurate dosing of the suspension, a measuring syringe is attached to the vial. 5 ml of the preparation contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.1. Insert the syringe firmly into the neck of the bottle. 2Turn the vial upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark. 3. Return the vial to its original position and remove the syringe by gently turning it. 4. Place the syringe into the baby’s oral cavity and slowly press the plunger, gently releasing the suspension. After use, rinse the syringe in warm water and dry it in a place inaccessible to the child.
Side effects
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose needed to eliminate the symptoms. The side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term ibuprofen in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and long-term use, other adverse reactions may occur. Evaluation of the incidence of adverse reactions was made based on the following criteria: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently ( from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (data on frequency estimates are not available). On the system side hematopoiesis: very rarely - hematogenous disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranul cell count). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, hemorrhages and hemorrhages of unknown etiology. For the immune system: rarely - hypersensitivity reactions (non-specific allergic reactions and anaphylactic reactions), reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, edema K Inca, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Lyell syndrome, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely - severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, angioedema or severe anaphylactic shock). From the gastrointestinal tract: infrequently - abdominal pain, nausea, dyspepsia; rarely - diarrhea, flatulence, constipation, vomiting; very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, ulcerative stomatitis,gastritis; the frequency is unknown - exacerbation of ulcerative colitis and Crohn's disease. From the side of the liver and biliary tract: very rarely - abnormal liver function. On the part of the urinary system: very rarely - acute renal failure (compensated and decompensated), especially with prolonged use, combined with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis. From the nervous system: infrequently - headache; very rarely - aseptic meningitis (in patients with autoimmune diseases). From the side of the cardiovascular system: the frequency is unknown - heart failure, peripheral edema, with long-term use the risk of thrombotic complications (eg myocardial infarction, stroke), increased blood pressure is increased. respiratory system: frequency is unknown - asthma, bronchospasm, shortness of breath. Others: very rarely - edema, incl. peripheral. Laboratory parameters: hematocrit or hemoglobin may decrease, bleeding time may increase, plasma glucose concentration may decrease, CC may decrease; plasma creatinine concentration may increase; Hepatic transaminase activity may increase. If you experience side effects, you should stop taking the drug and consult a doctor.
Overdose
In children, overdose symptoms may occur after taking a dose in excess of 400 mg / kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. T1 / 2 of the drug in overdose is 1.5-3 hours. Symptoms: nausea, vomiting, pain in the epigastric region or, rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely - excitement, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis can develop. Patients with bronchial asthma may have an exacerbation of this disease. Treatment: symptomatic, with mandatory airway management, monitoring of ECG and basic vital signs until the patient's condition is normalized.Oral administration of activated charcoal or gastric lavage for 1 hour after administration of a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be given to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped in / in the introduction of diazepam or lorazepam. With the worsening of bronchial asthma, the use of bronchodilators is recommended.
Interaction with other drugs
The simultaneous use of ibuprofen with the drugs listed below should be avoided. Acetylsalicylic acid: with the exception of acetylsalicylic acid in low doses (not more than 75 mg / day) prescribed by a doctor, because the combined use may increase the risk of side effects. With simultaneous use of ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients who receive acetylsalicylic acid in small doses as an antiplatelet agent after starting ibuprofen). Other NSAIDs, including selective COX-2 inhibitors : the simultaneous use of two or more drugs from the group of NSAIDs should be avoided due to the possible increase in the risk of side effects. use simultaneously with the following drugs. Anti-coagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs. Antihypertensives (ACE inhibitors and angiotensin II receptor antagonists) and diuretics can be used as an example. Diuretics and ACE inhibitors can increase the nephrotoxicity of NPVS.GKS: an increased risk of gastrointestinal ulcers and gastrointestinal bleeding. Antiaggregants and selective serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding. worsening heart failure, reducing glomerular filtration rate and increasing the concentration of cardiac glycosides in the blood plasma. Lithium preparations: exist data on the probability of increasing the concentration of lithium in the blood plasma during the use of NSAIDs.Methotrexate: there are data on the likelihood of increasing plasma concentration of methotrexate on the background of using NSAIDs. Cyclosporine: increasing the risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine. Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone because NSAIDs may reduce the effectiveness of mifepristone. Tacrolimus: with the simultaneous appointment of NSAIDs and tacrolimus, an increased risk of nephrotoxicity may be increased. Zidovudine: simultaneous use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received joint treatment with zidovudine and ibuprofen. Quinol antibiotics: in patients receiving joint treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase
special instructions
It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate the symptoms. During long-term treatment, monitoring of the peripheral blood and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is provided, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), occult blood test. If necessary, 17-ketosteroids should be determined. cancel 48 hours before the study. During the period of treatment ethanol is not recommended. The drug is contraindicated in patients with fructose intolerance, because contains maltitol. Nurofen for children can be used for children with diabetes, because the drug does not contain sugar. It does not contain dyes. Patients with renal insufficiency should be consulted with a doctor before using the drug, because there is a risk of deterioration of the functional state of the kidneys. Patients with arterial hypertension, including. history and / or chronic heart failure, you should consult with your doctor before using the drug, because the drug can cause fluid retention, increased blood pressure and edema