Nurofen coated pills 200mg N20
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Active ingredients
Ibuprofen
Release form
Pills
Composition
IbuprofenActivities: croscarmellose sodium - 30 mg, sodium lauryl sulfate - 0.5 mg, sodium citrate dihydrate - 43.5 mg, stearic acid - 2 mg, silicon dioxide, colloidal - 1 mg. The composition of the shell: carmellose sodium - 0.7 mg, talc - 33 mg, acacia gum - 0.6 mg, sucrose - 116.1 mg, titanium dioxide - 1.4 mg, macrogol 6000 - 0.2 mg, black ink [Opacode S-1-277001] (shellac - 28.225%, iron dye black oxide (E172) - 24.65%, propylene glycol - 1.3%, isopropanol * - 0.55%, butanol * - 9.75%, ethanol * - 32.275%, purified water * - 3.25%. * Solvents that evaporated after the printing process
Pharmacological effect
Anti-inflammatory, antipyretic, analgesic.
Pharmacokinetics
Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract. After taking the drug on an empty stomach, Cmax of ibuprofen in plasma is reached after 45 minutes. Taking the drug with food can increase Tmax up to 1–2 hours. Communication with plasma proteins is 90%. Slowly penetrates into the cavity of the joints, lingers in the synovial fluid, creating in it greater concentrations than in the blood plasma. In the cerebrospinal fluid found lower concentrations of ibuprofen compared with blood plasma. After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form. It is metabolized in the liver.T1 / 2 - 2 hours. Excreted in the urine (in an unchanged form, not more than 1%) and, to a lesser extent, in the bile. In limited studies, ibuprofen has been detected in breast milk at very low concentrations.
Indications
Headache; migraine; toothache; painful menstruation; neuralgia; back pain; muscle pain; rheumatic pain; pain in the joints; feverish conditions with the 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 NPVs (including history), erosive and ulcerative diseases of the gastrointestinal tract (including gastric 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 Ia); bleeding or gastrointestinal ulcer perforation in history,provoked by the use of NSAIDs, severe liver failure or liver disease in the active phase, severe renal failure (Cl creatinine <30 ml / min), confirmed hyperkalemia, decompensated heart failure, the period after coronary artery bypass surgery, cerebrovascular or other bleeding, fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, hemophilia and other bleeding disorders (including hypocoagulation), hemorrhoids giatic diathesis; pregnancy (III trimester); children's age up to 6 years.
Precautionary measures
With caution: simultaneous reception of other NSAIDs, the history of a single episode of gastric ulcer and duodenal ulcer or ulcerative bleeding of the gastrointestinal tract; 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; systemic lupus erythematosus or mixed connective tissue disease (Sharpe syndrome) - increased risk of aseptic meningitis; renal failure, incl. with dehydration (Cl creatinine <30–60 ml / min), nephrotic syndrome, liver failure, cirrhosis with portal hypertension, hyperbilirubinemia, arterial hypertension and / or heart failure, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, frequent use of alcohol, simultaneous use of drugs that may increase the risk of lung or bleeding, in particular, oral GCS (including prednisolone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel), pregnancy I – II trimesters, breastfeeding period, old age, age under 12 years.
Use during pregnancy and lactation
Use of the drug in the III trimester of pregnancy is contraindicated. It is necessary to avoid using 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, so usually with a short-term use, there is no need to stop breastfeeding. If necessary, long-term use of the drug should consult a doctor to decide whether to stop breastfeeding for the period of use of the drug.
Dosage and administration
Inside, drinking water. Patients with hypersensitivity of the stomach are advised to take the drug with meals. For short term use only. Before taking the drug, you should carefully read the instructions. Adults and children over 12 years old: inside on 1 table. (200 mg) up to 3-4 times per day. To achieve a faster therapeutic effect in adults, the dose can be increased to 2 table. (400 mg) up to 3 times a day. For children from 6 to 12 years: 1 tab. (200 mg) up to 3-4 times a day; the drug can be taken only in the case of a child's body weight of more than 20 kg. The interval between taking the pill should be at least 6 hours. The maximum daily dose for adults is 1200 mg (6 tab.). The maximum daily dose for children from 6 to 18 years is 800 mg (4 tab.). If the symptoms persist or worsen while 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 you take the drug in a short course, at the minimum effective dose necessary to eliminate the symptoms. In elderly people, there is an increased incidence of adverse reactions during the use of NSAIDs, especially gastrointestinal bleeding and perforations, in some cases with a fatal outcome. Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term ibuprofen in doses not exceeding 1200 mg / day (6 tab.). In the treatment of chronic conditions and long-term use, other adverse reactions may occur. The incidence of adverse reactions was estimated 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). blood and lymphatic system: very rarely - blood disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).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, nonspecific 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 vinca, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell's 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 (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; unknownness - exacerbation of colitis and Crohn's disease. From the liver and biliary tract: very rarely - abnormal liver function, increased activity of hepatic transaminases, hepatitis and jaundice. From the kidneys and urinary tract: 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 syndrome, papillary necrosis, int interstitial nephritis, cystitis. From the nervous system: infrequently - headache; very rarely - aseptic meningitis. For CVS: unknown frequency - heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (for example, myocardial infarction), elevation of blood pressure. From the respiratory system and mediastinal organs: frequency unknown - bronchial asthma, bronchospasm ,dyspnea. Laboratory parameters: hematocrit or Hb (may decrease); bleeding time (may increase); plasma glucose concentration (may decrease); creatinine clearance (may decrease); plasma creatinine concentration (may increase); activity of hepatic transaminases (may increase). In the event of 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. It is recommended oral administration of activated charcoal or gastric lavage for 1 hour after administration of a potentially toxic dose of ibuprofen. 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 LSA acetylsalicylic acid should be avoided: with the exception of low doses of acetylsalicylic acid (not more than 75 mg / day) prescribed by a doctor, since 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 receiving small doses of acetylsalicylic acid as an antiplatelet agentafter starting ibuprofen). Other NSAIDs, in particular, selective COX-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increase in the risk of side effects. Use caution with the following LSA and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs. Anti-hypertensive drugs (ACE inhibitors and ARA II) and diuretics: NSAIDs can reduce the effectiveness of drugs. ratov these groups. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous administration of ACE or APA II inhibitors and COX inhibitors can lead to a deterioration in renal function, including the development of acute renal failure ( usually reversible). These interactions should be considered in patients taking Coxibs at the same time as ACE or APA II inhibitors. In this regard, the combined use of the above funds should be prescribed with caution, especially in the elderly. It is necessary to prevent dehydration in patients, as well as to consider monitoring renal function after the start of such combined treatment and periodically in the future. Diuretics and ACE inhibitors may increase nephrotoxicity increased risk of gastrointestinal bleeding. Cardiac glycosides: co-administration of NSAIDs and cardiac glycosides can lead to worsening heart failure Accuracy, decrease in glomerular filtration rate and increase in the concentration of cardiac glycosides in the blood plasma. Preparations of lithium: there is evidence of the likelihood of increasing the concentration of lithium in the blood plasma during the use of NPVS. Cyclosporine: an increase in the risk of nephrotoxicity with the simultaneous appointment of NSAIDs and cyclosporine. Mifepristone: NSAID administration should be started no earlier than 8–12 days after taking mifepr It’s possible to increase the risk of nephrotoxicity. 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. Quinolone antibiotics: patients who receive joint treatment of NSAIDs and quinolone antibiotics may increase the risk of seizures. Myelotoxic drugs: hematotoxicity. Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the frequency of development of hypoprothrombinemia. LS, tubular blocking sec etsiyu: decrease in removal and increase in plasma concentration of ibuprofen. Microsomal oxidation inducers (Phenytome area, area of ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increase in production of hydroxylated active metabolites, increase in the risk of developing severe intoxication, microrosyrosis, anorestomy, and the growth of the hydroxylated active metabolites; hypoglycemic drugs and insulin, sulfonylurea derivatives: increased effect of drugs. Antacids and colestiramia: reduced abso Pharmaceuticals. Urikozuricheskie drugs: reduced efficacy of drugs. Caffeine: increased analgesic effect
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. If it is necessary to take the drug for more than 10 days, it is necessary to consult a doctor. In patients with bronchial asthma or an allergic disease in the acute stage, as well as in patients with a history of bronchial asthma / allergic disease, the drug can provoke bronchospasm. The use of the drug in patients with systemic lupus erythematosus or a mixed connective tissue disease is associated with an increased risk of aseptic meningitis. 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.During the period of treatment, ethanol is not recommended. Patients with renal insufficiency should consult with a physician before using the drug, because there is a risk of renal deterioration. Patients with hypertension, including in history and / or CHF, you should consult with your doctor before using the drug, because the drug can cause fluid retention, increased blood pressure and edema. Information for women planning pregnancy: the drug suppresses COX and GH synthesis, affects ovulation, impairing female reproductive function reversible after the cancellation of treatment). The effect on the ability to drive vehicles, mechanisms. Patients who notice dizziness, drowsiness, lethargy or visual impairment when taking ibuprofen, should avoid driving vehicles or driving mechanisms.