Nurofen express capsules 200mg N16
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Active ingredients
Ibuprofen
Release form
Capsules
Composition
Active ingredient: Ibuprofen (Ibuprophenum) Active ingredient concentration (mg): 200
Pharmacological effect
The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to the inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Indiscriminately blocks COX-1 and COX-2, as a result of which it inhibits prostaglandn synthesis. It has a quick directional effect against pain (pain reliever), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation.
Pharmacokinetics
Absorption and distribution Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract. After taking 2 capsules of the drug on an empty stomach, ibuprofen is detected in the blood plasma after 15 minutes, C max of ibuprofen in the blood plasma is reached after 30-40 minutes, which is 2 times faster than after taking the equivalent dose of the drug Nurofen in the dosage form of a 200 mg coated tablet. Taking the drug with food may increase Tmax. Binding to plasma proteins by more than 90%. Slowly penetrates the cavity of the joints, lingers in the synovial fluid, creating greater concentrations in it than in the blood plasma. Metabolism and excretion After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form. Metabolized in the liver. T1 / 2 - 2 hours. Excreted by the kidneys (unchanged, no more than 1%) and, to a lesser extent, with bile. In limited studies, ibuprofen was found in breast milk at very low concentrations. Pharmacokinetics in special groups of patients differences in the pharmacokinetic profile of the drug compared with younger people.
Indications
Headache; - migraine; - toothache; - painful menstruation; - neuralgia; - back pain; - muscle pain; - rheumatic pain; - fever with flu and colds.
Contraindications
Hypersensitivity to ibuprofen or any of the components that make up the drug - a complete or incomplete combination of asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including in history); - erosive and ulcerative diseases digestive tract organs (includingpeptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding); - bleeding or perforation of the gastrointestinal ulcer in history, provoked by the use of NSAIDs; 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; - fructose intolerance; - hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; - III trimester of pregnancy; - children under 12 years old.
Precautionary measures
Use with caution simultaneously with the following drugs: Anti-coagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs. Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of these groups. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs. GCS: an increased risk of ulceration of the gastrointestinal tract and gastrointestinal bleeding.Antiagreganty and selective inhibitors of serotonin reuptake: an increased risk of gastrointestinal bleeding. to the aggravation of heart failure, a decrease in the glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma. Preparations l tia: there are data on the likelihood of increasing the plasma concentration of lithium in the background of using NSAIDs. Metotrexat: there are data on the likelihood of increasing the concentration of methotrexate in the blood plasma on the background of using NSAIDs. should start no earlier than 8-12 days after taking mifepristone, because NSAIDs can reduce the effectiveness of mifepristone. Tacrolimus: while prescribing NSAIDs and tacrolimus You can increase the risk nefrotoksichnosti.Zidovudin: the simultaneous use of NSAIDs and zidovudine may increase gematotoksichnosti.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. cefotetan, valproic acid, plicamycin: an increase in the incidence of hypoprothrombinemia. Drugs that block tubular secretion: a decrease in excretion and increase e-plasma ibuprofena and insulin: increased effect. Antacids and Kolestiramine: reduced absorption. Caffeine: increased anal Gezira effect.
Use during pregnancy and lactation
Use of the drug in the III trimester of pregnancy is contraindicated. It is necessary to avoid the use of the drug in the I-II trimesters of pregnancy, if necessary, you should consult with your doctor. There is evidence that ibuprofen in small quantities can penetrate into breast milk without any negative consequences for the health of the infant, therefore usually with short-term There is no need to stop breastfeeding. If you need long-term use of the drug, you should contact your doctor to decide whether to stop breastfeeding for the period of use of the drug. Information for women planning pregnancy: these drugs suppress COX and prostaglandin synthesis, affect ovulation, impairing female reproductive function (reversibly after discontinuation of treatment ).
Dosage and administration
Carefully read the instructions before taking the drug. For oral administration. Only for short-term use. Adults and children over 12 years: inside 200 mg (1 capsule) 3-4 times / day. The capsule is taken without chewing, drinking water.The interval between doses of the drug should be 6-8 hours. To achieve a faster therapeutic effect in adults, the dose can be increased up to 2 capsules (400 mg) up to 3 times / day. The maximum daily dose is 1200 mg. The maximum daily dose for children 12- 17 years is 1000 mg. If the symptoms persist or worsen when taking the drug for 2-3 days, you should stop treatment and consult a doctor.
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. Side effects are predominantly dose-dependent. The following side effects were observed with short-term ibuprofen in doses not exceeding 1200 mg / day (6 capsules). 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 (there are no estimates of the frequency). From the blood side and lymphatic system: very rarely - blood disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, granulocytosis). 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. On the immune system: infrequent - hypersensitivity reactions - non-specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its aggravation, bronchospasm, shortness of breath, dyspnea), 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). On the part of the digestive system: rarely - abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely - diarrhea, flatulence, constipation,vomiting; very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases with a fatal outcome, especially in elderly patients, ulcerative stomatitis, gastritis; frequency is unknown - exacerbation of colitis and Crohn's disease. From the liver and biliary tract: very rarely - abnormal liver function (especially with prolonged use), increased activity of hepatic transaminases, hepatitis and jaundice. From the urinary system: very rare - acute renal failure ( compensated and decompensated) especially with long-term use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic th syndrome, papillary necrosis, interstitial nephritis, cystitis. For the nervous system: infrequently - headache; very rarely - aseptic meningitis. From the side of the cardiovascular system: the frequency is unknown - heart failure, peripheral edema, with prolonged use the risk of thrombotic complications (for example, myocardial infarction) is increased, the blood pressure is increased. From the respiratory system: the frequency is unknown - bronchial asthma, bronchospasm, shortness of breath. From the side of the skin and subcutaneous tissues: rarely - itching, urticaria, purpura, exfoliative and bullous dermatoses, incl. toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme. Other: very rare - edema, incl. peripheral.
Overdose
In children, overdose symptoms may occur after taking the vine 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. If bronchial asthma worsens, use of bronchodilators is recommended.
Interaction with other drugs
The simultaneous use of ibuprofen with the following drugs should be avoided. Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (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 small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen). It is necessary to avoid the simultaneous use of two or more drugs from the group of NSAIDs because of the possible increase in the risk of side effects.
special instructions
It is recommended to take the drug as soon as possible and at the minimum effective dose necessary to eliminate the symptoms. During long-term treatment, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, a careful monitoring is shown, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), fecal occult blood test. If necessary, determine the 17-ketosteroids drug should be canceled 48 hours before the study. Ethanol is not recommended during treatment. Patients with renal insufficiency should consult a physician before using the drug, because there is a risk of renal impairment. 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. Effects on the ability to drive vehicles and control mechanismsPatients who notice dizziness, drowsiness, inhibition or visual impairment taking ibuprofen, you should avoid driving vehicles or driving mechanisms.