Nurofen tablets 200 mg No. 20
Compound
Active substance: ibuprofen 200 mg.
Excipients: croscarmellose sodium - 30 mg, sodium lauryl sulfate - 0.5 mg, sodium citrate dihydrate - 43.5 mg, stearic acid - 2 mg, colloidal silicon dioxide - 1 mg.
Shell composition: 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 oxide black (E172) 24.65%, propylene glycol 1.3%, isopropanol* 0.55%, butanol* 9.75%, ethanol* 32.275%, purified water* 3.25%).
* solvents that have evaporated after the printing process.
Pharmacokinetics
Absorption is high, binding to plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating higher concentrations in it than in plasma. Lower concentrations of ibuprofen are found in cerebrospinal fluid compared to plasma. After absorption, about 60% of the pharmacologically inactive R form is slowly transformed into the active S form in the gastrointestinal tract and liver. Metabolized in the liver. The time to reach the maximum concentration in plasma Tmax is 1-2 hours. The half-life is 2 hours. It is excreted by the kidneys (70-90% of the administered dose in the form of ibuprofen and its metabolites; unchanged, no more than 1%) and, to a lesser extent, with bile (less than 2%).
Indications for use
Nurofen is used for headaches and toothaches, migraines, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; as well as in case of fever due to influenza and colds.
Contraindications
- Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, including gastric and duodenal ulcers in the acute phase, ulcerative colitis, peptic ulcer, Crohn's disease;
- heart failure;
- severe arterial hypertension;
- hypersensitivity to ibuprofen or to the components of the drug;
- complete or incomplete acetylsalicylic acid intolerance syndrome (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- optic nerve diseases; impaired color vision, amblyopia, scotoma;
- deficiency of glucose-b-phosphate dehydrogenase, hemophilia and other bleeding disorders, hemorrhagic diathesis, hypocoagulation conditions
- pregnancy III trimester, lactation period;
- severe liver dysfunction;
- severe renal failure (creatinine clearance less than 30 ml/min);
- hearing loss, pathology of the vestibular apparatus;
- period after coronary artery bypass surgery;
- gastrointestinal bleeding and intracranial hemorrhage;
- hemophilia and other bleeding disorders, hemorrhagic diathesis;
- children under 6 years old.
With caution: elderly age, coronary heart disease, cerebrovascular diseases, dyslipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, frequent alcohol consumption, long-term use of NSAIDs, severe somatic diseases, concomitant use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin, clopidogrel, acetylsalicylic acid), taking selective serotonin reuptake inhibitors, diseases when taking the drug in patients with a history of gastric and duodenal ulcers, gastritis, enteritis, colitis, with anamnestic information about bleeding from the gastrointestinal tract; in the presence of concomitant liver and/or kidney diseases; for liver cirrhosis with portal hypertension, nephrotic syndrome, chronic heart failure; arterial hypertension; for blood diseases of unknown etiology (leukopenia and anemia); for bronchial asthma, for hyperbilirubinemia; pregnancy (I, II trimesters); age under 12 years.
Directions for use and doses
NUROFEN® is prescribed to adults and children over 12 years of age orally, after meals, in tablets of 200 mg 3-4 times a day. The tablets should be taken with water.
To achieve a rapid therapeutic effect in adults, the dose can be increased to 400 mg (2 tablets) 3 times a day.
Children from 6 to 12 years old: 1 tablet no more than 4 times a day; the drug can only be used if the child weighs more than 20 kg. The interval between taking tablets is at least 6 hours. Do not take more than 6 tablets in 24 hours. The maximum daily dose is 1200 mg. If symptoms persist after taking the drug for 2-3 days, you should stop treatment and consult a doctor.
Storage conditions
Store in a dry place at a temperature not exceeding + 25°C. Keep the drug out of the reach of children.
Best before date
3 years. Do not use a drug that has expired.
special instructions
It is recommended to prescribe ibuprofen for the shortest possible course and at the minimum effective dose necessary to eliminate symptoms. If systemic use is necessary for more than 10 days, you should consult your doctor.
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood.
The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). Therefore, it is recommended to avoid the use of ibuprofen for chickenpox.
Ibuprofen suppresses COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).
Description
Non-steroidal anti-inflammatory drug (NSAID).
Use in children
Ibuprofen is contraindicated in children under 6 years of age (at a dose of 200 mg).
Pharmacodynamics
NSAIDs, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic and antipyretic effects.
The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both peripheral (indirectly, through suppression of prostaglandin synthesis) and central mechanisms (inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation.
Side effects
When using the drug NUROFEN® for 2-3 days, practically no side effects are observed. In case of long-term use, the following side effects may occur:
From the gastrointestinal tract: nausea, vomiting, heartburn, anorexia, pain and discomfort in the epigastrium, diarrhea, flatulence, possible erosive and ulcerative lesions of the gastrointestinal tract (in some cases complicated by perforation and bleeding), abdominal pain, irritation , dryness of the oral mucosa or pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.
From the nervous system: headache, dizziness, insomnia, agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).
From the cardiovascular system: heart failure, increased blood pressure (BP), tachycardia.
From the urinary system: nephrotic syndrome (edema), acute renal failure, allergic nephritis, polyuria, cystitis.
From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.
From the senses: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma.
Allergic reactions: skin rash, itching, urticaria, Quincke's edema, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
From the respiratory system: bronchospasm, shortness of breath.
Other: increased sweating.
With long-term use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).
Use during pregnancy and breastfeeding
Use during pregnancy and breastfeeding is contraindicated.
Interaction
With simultaneous use, ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).
When used simultaneously with anticoagulants, their effect may be enhanced.
When used simultaneously with GCS, the risk of side effects from the gastrointestinal tract increases.
When used simultaneously, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), and oral hypoglycemic drugs, sulfonylurea derivatives, from compounds with blood plasma proteins.
When used simultaneously with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid - the concentration of ibuprofen in the blood plasma decreases; with baclofen - a case of increased toxic effects of baclofen has been described.
When used simultaneously with warfarin, an increase in bleeding time is possible; microhematuria and hematomas were also observed; with captopril - the antihypertensive effect of captopril may be reduced; with cholestyramine - a moderate decrease in the absorption of ibuprofen.
When used simultaneously with lithium carbonate, the concentration of lithium in the blood plasma increases.
When used simultaneously with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate - the toxicity of methotrexate increases.
The simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.
There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.
With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.
NSAIDs may reduce the effectiveness of mifepristone, so taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.
Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Concomitant 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 concomitant treatment with zidovudine and ibuprofen.
In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.
In patients receiving concomitant NSAIDs and myelotoxic drugs, hematotoxicity increases.
With the simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the incidence of hypoprothrombinemia increases.
With the simultaneous use of ibuprofen and drugs that block tubular secretion, there is a decrease in excretion and an increase in plasma concentration of ibuprofen.
With the simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), there is an increase in the production of hydroxylated active metabolites and an increased risk of developing severe intoxications.
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal and liver failure, gastrointestinal bleeding, decreased blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest, increased prothrombin time, rarely convulsions.
Treatment: gastric lavage (only within an hour after administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy. In case of frequent or prolonged seizures, it is necessary to use anticonvulsants (diazepam or lorazepam intravenously).
Impact on the ability to drive vehicles and operate machinery
Patients should refrain from all activities related to driving vehicles and working with moving mechanisms, as well as other types of potentially hazardous activities associated with concentration and increased speed of psychomotor reactions.
Nurofen Express, 24 pcs., 200 mg, capsules
The simultaneous use of ibuprofen with the following drugs should be avoided
Acetylsalicylic acid:
with the exception of low doses of acetylsalicylic acid (no more than 75 mg/day) prescribed by a doctor, since combined use may increase the risk of side effects. With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after 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 increased risk of side effects.
Use with caution simultaneously with the following drugs
Anticoagulants and thrombolytic drugs:
NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.
Antihypertensive drugs (ACE inhibitors and ARA II) and diuretics:
NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (for example, dehydrated patients or elderly patients with impaired renal function), co-administration of ACE inhibitors or ARB II and COX-inhibiting agents may 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 concomitantly with ACE inhibitors or ARB II. In this regard, the combined use of the above drugs should be prescribed with caution, especially in elderly people. Patients should be prevented from dehydration and consideration should be given to monitoring renal function upon initiation of this combination treatment and periodically thereafter.
Diuretics and ACE inhibitors:
may increase the nephrotoxicity of NSAIDs.
GKS:
increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet agents and SSRIs:
increased risk of gastrointestinal bleeding.
Cardiac glycosides:
simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in GFR and an increase in the concentration of cardiac glycosides in the blood plasma.
Lithium preparations:
There is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs.
Methotrexate:
There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.
Cyclosporine:
increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine.
Mifepristone:
NSAIDs should be started no earlier than 8–12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.
Tacrolimus:
with simultaneous administration of NSAIDs and tacrolimus, the risk of nephrotoxicity may increase.
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 concomitant treatment with zidovudine and ibuprofen.
Quinolone antibiotics:
in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.
Myelotoxic drugs:
increased hematotoxicity.
Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin:
increased incidence of hypoprothrombinemia.
Drugs that block tubular secretion:
decreased excretion and increased plasma concentrations of ibuprofen.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants):
increased production of hydroxylated active metabolites, increased risk of developing severe intoxications.
Microsomal oxidation inhibitors:
reducing the risk of hepatotoxicity.
Oral hypoglycemic drugs and insulin, sulfonylurea derivatives:
enhancing the effect of drugs.
Antacids and colestyramics:
decreased absorption.
Uricosuric drugs:
decreased effectiveness of drugs.
Caffeine:
enhancing the analgesic effect.
