Nurofen express forte capsules 400mg N10
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Active ingredients
Ibuprofen
Release form
Capsules
Composition
Active ingredient: ibuprofen Concentration of active ingredient (mg): 400 mg
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 into the cavity of the joints, is retained 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 is slowly transformed 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 Elderly people were not found to be significant differences in the pharmacokinetic profile of the drug compared with younger people.
Indications
Headache, toothache, migraine, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; feverish conditions with flu and colds.
Contraindications
Hypersensitivity; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, including ulcerative colitis; severe arterial hypertension; "Aspirin" bronchial asthma, urticaria, rhinitis,provoked by taking acetylsalicylic acid (salicylates) and other NSAIDs; diseases of the optic nerve, impaired color vision, amblyopia, scotoma; deficiency of glucose-6-phosphate dehydrogenase, hemophilia, hypocoagulation state, leukopenia; pregnancy, lactation; renal and / or liver dysfunction; hearing loss, pathology of the vestibular apparatus; children's age up to 12 years.
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. Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of these drugs in 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 serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding. Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can 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. Cyclosporine: an increase in the risk of nephrotoxicity with the simultaneous administration of NSAIDs and cyclosporine. 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. Quinolone antibiotics: in patientsreceiving a joint treatment of NSAIDs and anti-biotics of the hnnolonovogo range, may increase the risk of seizures. Cefamendol, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the incidence of hypoprothrombinemia. phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): an increase in the production of hydroxylated are active x metabolites, increased risk of severe intoxication. Microsomal oxidation inhibitors: reduced risk of hepatotoxic action. Oral hypoglycemic drugs sulfonylurea derivatives and insulin: increased effect. Antacids and colestiramine: reduced absorption. Caffeine: increased analgesic 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
Adults and children over 12 years old are prescribed orally 200 mg 3-4 times / day. To achieve a rapid therapeutic effect, the dose may be increased to 400 mg 3 times / day. The maximum daily dose for adults is 1.2 g. The maximum daily dose for children and adolescents between the ages of 12 and 17 is 1 g. The capsule should be taken with water. The patient should be warned that if diseases remain, it is necessary to stop treatment and to see a doctor.
Side effects
On the part of the digestive system: NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; it is possible - increased activity of hepatic transaminases; rarely - erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract, which in some cases are complicated perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, hepatitis. From the side of the central nervous system: headache, dizziness, insomnia, anxiety, nervousness, irritability, psychomotor agitation, sleepiness, depression, confusion, hallucination ; rarely - aseptic meningitis (more often in patients with autoimmune diseases). From the cardiovascular system: heart failure, tachycardia, increased blood pressure. From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis; perhaps a decrease in QA, an increase in serum creatinine concentration. From the sense organs: hearing loss, ringing or tinnitus, toxic damage to the optic nerve, blurred vision or diplopia, dryness and eye irritation, conjunctival and eyelid edema (allergic genesis), scotoma. On the part of the respiratory system: shortness of breath, bronchospasm. On the side of the hematopoietic system: anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia; possibly - increased bleeding time, hematocrit or hemoglobin reduction Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis. Others: increased sweating; a decrease in the concentration of glucose in the blood is possible. When using the drug for 2-3 days, the side effect is observed very rarely.
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 mechanisms taking ibuprofen, you should avoid driving vehicles or driving mechanisms.