Pharmacological properties
Pharmacodynamics.
Ibuprofen is a propionic acid derivative NSAID that has demonstrated effectiveness by inhibiting prostaglandin synthesis. In humans, ibuprofen reduces the severity of pain due to inflammation, swelling and fever. in addition, ibuprofen reversibly inhibits platelet aggregation. Experimental evidence suggests that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when these drugs are administered concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were administered within 8 hours before or 30 minutes after immediate-release acetylsalicylic acid (81 mg), a decrease in the effect of acetylsalicylic acid on thromboxane formation or platelet aggregation was observed. Although there is uncertainty regarding the extrapolation of these data to the clinical situation, the possibility cannot be ruled out that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With unsystematic use of ibuprofen, such a clinically significant effect is considered unlikely. Nurofen relieves pain, reduces inflammation and lowers body temperature.
Pharmacokinetics. Ibuprofen is quickly absorbed after administration and is quickly distributed throughout the body. Elimination is rapid and complete and occurs through the kidneys. Cmax in blood plasma is achieved 45 minutes after oral administration on an empty stomach. When used with food, Cmax is achieved within 1–2 hours. This time may vary for different dosage forms. T½ is about 2 hours.
In elderly patients, there are no significant differences in the pharmacokinetic profile.
In limited studies, ibuprofen has been detected in breast milk at very low concentrations.
Application
Nurofen. for short-term use only. The tablets must be taken with water without chewing. During short-term use, if symptoms persist or worsen, the patient should consult a doctor.
Side effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms. If symptoms persist more than 5 days from the start of treatment or worsen, you should consult a doctor.
The drug is prescribed to adults and children weighing 20 kg (about 6 years of age). The recommended daily dose of the drug is 20–30 mg/kg body weight per day. Do not exceed a dose of 30 mg/kg body weight.
Children weighing 20–30 kg (6–11 years) are prescribed 200 mg (1 tablet) per dose. Repeat the dose, if necessary, after 6 hours. Do not exceed the dose of 600 mg (3 tablets) per day.
For adults and children weighing 30 kg, use 200–400 mg (1–2 tablets) per dose. A repeat dose is used if necessary after 4–6 hours. Do not exceed the dose of 1200 mg (6 tablets) within 24 hours.
Elderly people do not require special dosing.
Nurofen Forte. For oral administration for short-term use.
Adults and children over 12 years of age. The drug is used 1 tablet every 4 hours. The tablets must be washed down with water. Do not take 3 tablets within 24 hours. The maximum daily dose is 1200 mg.
The minimum effective dose should be used for the shortest possible period necessary to eliminate symptoms. If necessary, use the drug for 10 days, if the symptoms do not disappear or their severity increases, the patient should consult a doctor.
Elderly patients do not require special dosing.
Patients with mild or moderate renal and hepatic impairment do not require dose adjustment.
Instructions for use
It is better to use the medicine only after consultation with a specialist and as prescribed.
Tablets can be given to adults and children over 12 years of age, no more than 200 mg 3-4 times a day. The drug is taken after meals. For faster and more noticeable results, you can double the dose and take it 3 times a day.
The ointment is intended for external use. Can only be used by persons over 12 years of age. No more than 125 mg of the main active ingredient can be used at a time. The gel can be applied no more than 4 times a day, with an interval of at least 4 hours. If after 12-14 days the condition does not improve, then you should stop taking the drug.
Contraindications
Hypersensitivity to ibuprofen or any of the components of the drug.
Hypersensitivity reactions (eg asthma, rhinitis, angioedema or urticaria) that have previously been noted after the use of ibuprofen, acetylsalicylic acid or other NSAIDs.
Active gastric ulcer/bleeding or history of relapses (2 or more severe episodes of peptic ulcer or bleeding).
History of gastrointestinal bleeding or perforation associated with NSAID use.
Severe impairment of liver and kidney function; heart failure (class IV according to the NYHA classification).
Last trimester of pregnancy.
Hematopoiesis or blood clotting disorder.
Active inflammatory bowel disease.
Cerebrovascular or other bleeding (Nurofen Forte).
Components and release form
The drug is produced in 2 forms: gel and tablets. The tablets are coated with a light film and have a round shape. Sold in packages.
Nurofen in gel form is intended for external use. It has a colorless and homogeneous consistency with an inherent odor of alcohol.
The main component is ibuprofen. The tablets contain auxiliary elements: croscarmellose sodium, colloidal silicon dioxide, stearic acid.
Additional components in the gel are: sodium hydroxide, isopropyl alcohol, water.
Side effects
Adverse reactions observed with the use of ibuprofen and other NSAIDs are classified according to organ systems and the frequency of their manifestation: very often (≥1/10); often (≥1/100, 1/10); uncommon (≥1/1000, 1/100); rare (≥1/10,000, 1/1000); very rare (1/10,000) and unknown (cannot be estimated due to limited data available).
The list of the following adverse reactions refers to those observed with the use of ibuprofen in over-the-counter doses for short-term use. When treating chronic conditions, long-term treatment may cause additional side effects.
The most commonly reported adverse reactions were from the gastrointestinal tract. Adverse reactions are generally dose dependent, including the risk of gastrointestinal bleeding depending on the dose and duration of treatment.
From the blood and lymphatic system: very rarely - hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe malnutrition, unexplained bleeding and bruises of unknown etiology.
From the immune system: hypersensitivity reactions1; infrequently - urticaria and itching; very rarely - severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylactic reactions, angioedema or severe shock); frequency unknown - airway reactivity, including asthma, exacerbation of asthma, bronchospasm or shortness of breath.
From the nervous system: infrequently - headache; very rarely - aseptic meningitis2.
From the cardiac system: frequency unknown - heart failure, edema.
Clinical trial and epidemiological data suggest that the use of ibuprofen, especially at a high dose of 2400 mg/day and during long-term treatment, may be associated with a slightly increased risk of arterial thrombotic complications (eg, myocardial infarction or stroke).
From the vascular system: frequency unknown - hypertension.
From the digestive system: infrequently - abdominal pain, nausea, dyspepsia; rarely - diarrhea, flatulence, constipation and vomiting; very rarely - peptic ulcer of the stomach and duodenum, perforation or gastrointestinal bleeding, melena, hematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis; frequency unknown - exacerbation of colitis and Crohn's disease.
From the liver: very rarely - impaired liver function.
From the skin and subcutaneous tissue: infrequently - various rashes on the skin; very rarely - severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur.
From the respiratory tract and mediastinal organs: frequency unknown - respiratory tract reactivity, including asthma, bronchospasm or shortness of breath.
From the kidneys and urinary system: very rarely - acute renal dysfunction, papillonecrosis, especially with long-term use, associated with an increase in urea levels in the blood serum, and edema; frequency unknown - renal failure.
Laboratory tests: very rarely - decreased hemoglobin levels.
Description of selected adverse reactions
1There have been reports of hypersensitivity reactions following treatment with ibuprofen. Such reactions include (a) nonspecific allergic reactions and anaphylaxis, (b) respiratory reactions, including asthma, exacerbation of asthma, bronchospasm or shortness of breath, or (c) various skin disorders, including various types of rashes, itching, urticaria, purpura, angioedema and, less commonly, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
2The mechanism of pathogenesis of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAIDs indicate a hypersensitivity reaction (due to the timing of drug administration and the disappearance of symptoms after drug discontinuation). In particular, isolated cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever and confusion) have been observed when treating patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) with ibuprofen.
Nurofen forte tablet p o 400 mg pack cont cell/pack card x12
Trade name: Nurofen forte International name: Ibuprofen
Release form: film-coated tablets 400 mg (blisters)
Ingredients: ibuprofen 400 mg
Pharmacological group: NSAID (non-steroidal anti-inflammatory drug)
Pharmacological group according to ATK: M01AE01 (Ibuprofen)
Pharmacological action: antiplatelet, antipyretic, NSAID, anti-inflammatory, analgesic,
Indications: Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, juvenile chronic, psoriatic arthritis, osteochondrosis, neuralgic amyotrophy (Personage-Turner disease), arthritis with SLE (as part of complex therapy), gouty arthritis (in case of an acute attack of gout, fast-acting medications are preferred forms), ankylosing spondylitis (ankylosing spondylosis). Pain syndrome: myalgia, arthralgia, ossalgia, arthritis, sciatica, migraine, headache (including menstrual syndrome) and toothache, cancer, neuralgia, tendinitis, tendovaginitis, bursitis, neuralgic amyotrophy (Personage-Turner disease) , post-traumatic and postoperative pain syndrome, accompanied by inflammation. Algodismenorrhea, inflammatory process in the pelvis, incl. adnexitis, childbirth (as an analgesic and tocolytic agent). Feverish syndrome with “colds” and infectious diseases.
Dosage regimen: Inside, after meals. Adults: for osteoarthritis, psoriatic arthritis and ankylosing spondylitis - 400-600 mg 3-4 times a day. For rheumatoid arthritis - 800 mg 3 times a day, for soft tissue injuries, sprains - 1.6-2.4 g / day in several doses. For algodismenorrhea - 400 mg 3-4 times a day, for moderate pain syndrome - 1.2 g / day. For children over 12 years of age, the initial dose is 150-300 mg 3 times a day, the maximum dose is 1 g, then 100 mg 3 times a day, for juvenile rheumatoid arthritis - 30-40 mg/kg/day in several doses. To reduce body temperature 39.2 degrees C and above - 10 mg/kg/day, below 39.2 degrees C - 5 mg/kg/day. Oral suspension - 5-10 mg/kg 3 times a day: children aged 6-12 months (only as prescribed by a doctor) - an average of 50 mg 3-4 times a day, 1-3 years - 100 mg 3 times per day, 4-6 years - 150 mg 3 times a day, 7-9 years - 200 mg 3 times a day, 10-12 years - 300 mg 3 times a day. For febrile syndrome after immunization - 50 mg, if necessary, after 6 hours, repeat administration at the same dose, maximum daily dose - 100 mg.
Contraindications: Hypersensitivity, erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease - nonspecific ulcerative colitis), "aspirin" asthma, blood clotting disorders (including hemophilia, prolongation of bleeding time, bleeding tendency, hemorrhagic diathesis), pregnancy, lactation.
Side effects: From the digestive system: NSAID gastropathy (nausea, vomiting, abdominal pain, heartburn, loss of appetite, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding) , irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis. From the respiratory system: shortness of breath, bronchospasm. 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. From the nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases). From the cardiovascular system: development or worsening of heart failure, tachycardia, increased blood pressure. From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis. Allergic reactions: skin rash (usually erythematous, urticaria), skin itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome) , eosinophilia, allergic rhinitis. From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Other: increased sweating. The risk of developing ulcerations of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia) increases with long-term use in large doses. Overdose. Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest. Treatment: gastric lavage (only within an hour after administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of CBS, blood pressure).
Pharmacodynamics: NSAIDs have analgesic, antipyretic and anti-inflammatory effects due to non-selective blockade of COX1 and COX2 and have an inhibitory effect on Pg synthesis. The analgesic effect is most pronounced for inflammatory pain. Like all NSAIDs, ibuprofen exhibits antiplatelet activity.
Pharmacokinetics: Well absorbed from the gastrointestinal tract. Absorption is slightly reduced when taking the drug after meals. TCmax when taken on an empty stomach - 45 minutes, when taken after meals - 1.5-2.5 hours, in synovial fluid - 2-3 hours (where it creates higher concentrations than in plasma). 90% bound to plasma proteins. Subject to presystemic and postsystemic metabolism in the liver. After absorption, approximately 60% of the pharmacologically inactive R form of ibuprofen is slowly transformed into the active S form. The CYP2C9 isoenzyme takes part in the metabolism of the drug. It has two-phase elimination kinetics with T1/2 2-2.5 hours (for retard forms - up to 12 hours). It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.
Special instructions: During 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 blood test to determine Hb, hematocrit, and a stool test for occult blood. To prevent the development of NSAID gastropathy, it is recommended to combine it with PgE drugs (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Patients should refrain from all activities that require increased attention, rapid mental and motor reactions. During the treatment period, ethanol intake is not recommended. Carefully. Cirrhosis of the liver with portal hypertension, hyperbilirubinemia, peptic ulcer of the stomach and duodenum (history), gastritis, enteritis, colitis, liver and/or renal failure, nephrotic syndrome, CHF, arterial hypertension, blood diseases of unknown etiology (leukopenia and anemia ), children's age (for tablet forms - up to 12 years, 6 months - for oral suspension). Children 6-12 months are prescribed only on the recommendation of a doctor.
Interaction: Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions. Microsomal oxidation inhibitors reduce the risk of hepatotoxicity. Reduces the hypotensive activity of vasodilators (including BMCC and ACE inhibitors), natriuretic and diuretic activity - furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications), ulcerogenic effect with bleeding of MCS and GCS, colchicine, estrogens, ethanol, enhances the effect of oral hypoglycemic drugs and insulin. Antacids and cholestyramine reduce the absorption of ibuprofen. Increases the blood concentration of digoxin, Li+ drugs and methotrexate. Caffeine enhances the analgesic effect. When administered simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effects of ASA (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of ASA as an antiplatelet agent is possible after starting ibuprofen). When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding simultaneously increases. Cefamandole, cefaperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. Cyclosporine and Au preparations enhance the effect of ibuprofen on Pg synthesis in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects. Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.
Dispensed from pharmacies: Dispensed by prescription.
Drug registration number: P No. 016033/01
Date of registration (re-registration) of the drug: December 29, 2006
special instructions
Side effects can be reduced by using the minimum effective dose needed to relieve symptoms for a short period.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
Effect on the cardiovascular and cerebrovascular system. Patients with a history of hypertension and/or heart failure should initiate treatment with caution (consult a physician or pharmacist) as cases of fluid retention, hypertension and edema associated with NSAID therapy have been reported.
Data from clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a slightly increased risk of arterial thrombotic complications (eg, myocardial infarction or stroke). In general, data from epidemiological studies do not suggest that low-dose ibuprofen (eg, ≤1200 mg/day) is associated with an increased risk of arterial thrombotic events.
In patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), diagnosed coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, treatment with ibuprofen should only be prescribed by a physician after a thorough analysis of the clinical picture. High doses (2400 mg/day) should be avoided. In patients with risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), long-term treatment with NSAIDs should also be prescribed only after a careful assessment of the clinical picture, especially if high doses of ibuprofen (2400 mg/day) are required.
Effects on the respiratory system. Bronchospasm may occur in patients with asthma or allergic diseases or a history of these diseases.
Other NSAIDs. Concomitant use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, should be avoided.
Systemic lupus erythematosus and mixed connective tissue diseases. Ibuprofen should be used with caution in cases of systemic lupus erythematosus and mixed connective tissue diseases due to the increased risk of aseptic meningitis.
Cases of aseptic meningitis have been reported with ibuprofen. Although this effect is more likely in patients with systemic lupus erythematosus and other connective tissue diseases, it has also been reported in some patients without chronic diseases and should therefore be taken into account when using this drug.
Effect on the kidneys and liver. Caution should be exercised in patients with renal failure due to the possibility of deterioration of renal function. Ibuprofen should be used with caution in patients with renal or hepatic disease, especially during concomitant diuretic therapy, as inhibition of prostaglandin synthesis may lead to fluid retention and further deterioration of renal function. In such patients, the lowest possible dose of ibuprofen should be used and renal function should be monitored regularly. If dehydrated, ensure adequate fluid intake. There is a risk of kidney failure in children (6 years of age and older) and adolescents who are dehydrated.
In general, systematic use of analgesics, especially combinations of different analgesics, can lead to long-term kidney damage with a risk of renal failure (analgesic nephropathy). The highest risk of this reaction exists in elderly patients, patients with renal, cardiac and hepatic impairment, and those receiving diuretics or ACE inhibitor therapy. After cessation of NSAID therapy, a return to pre-treatment status is usually achieved.
Like other NSAIDs, ibuprofen may cause small temporary increases in certain liver function tests, as well as significant increases in AST and ALT levels. If these indicators increase significantly, treatment should be discontinued.
With long-term use of ibuprofen, it is necessary to regularly check liver function, kidney function, and hematological function/blood picture.
Effect on fertility in women. There is limited evidence that drugs that inhibit COX/prostaglandin synthesis may impair fertility in women by interfering with ovulation. This process is reversible after stopping treatment.
Effect on the gastrointestinal tract. NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. There are reports of cases of gastrointestinal bleeding, perforation, ulcers, possibly fatal, that occurred at any stage of treatment with NSAIDs, regardless of the presence of warning symptoms or a history of gastrointestinal disorders.
The risk of gastrointestinal bleeding, perforation, and ulcers increases with increasing doses of NSAIDs in patients with a history of ulcers, especially if complicated by bleeding or perforation, and in elderly patients. These patients should begin treatment with minimal doses.
In these patients, as well as in patients who require simultaneous use of low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, combination therapy with protective drugs (for example, misoprostol or proton pump inhibitors) is recommended.
Patients with a history of GI toxicity, especially the elderly, should be advised of any unusual GI symptoms (especially GI bleeding), particularly at the start of treatment.
Long-term use of any painkillers to treat headaches may worsen the condition. In such cases, you should consult a doctor and stop treatment. The possibility of headache resulting from drug abuse should be considered in patients with frequent or daily headaches despite (or as a result of) regular use of anti-headache medications.
Caution should be exercised when treating patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (eg, acetylsalicylic acid).
In the event of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued immediately.
From the skin and subcutaneous tissue. Very rarely, severe skin reactions that can be fatal may occur with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The highest risk of such reactions is observed in the early stages of therapy, in most cases their onset occurs in the first month of treatment. Ibuprofen should be discontinued at the first sign of skin rash, pathological changes in the mucous membranes, or any other signs of hypersensitivity.
In exceptional cases, chickenpox can cause severe infectious complications of the skin and soft tissues. At present, the influence of NSAIDs on the worsening of this infection cannot be ruled out, so it is recommended to avoid the use of Nurofen for chickenpox.
Nurofen Forte. 1 tablet contains 232.2 mg (0.68 mmol) of sucrose. The drug should be used with caution in patients with diabetes mellitus.
Patients with a rare hereditary form of fructose intolerance, glucose-galactose malabsorption syndrome, or deficiency of the enzymes sucrase or isomaltase should not take this drug.
Nurofen contains 25.3 mg (or 1.1 mmol) sodium per 2 tablets, and each tablet of Nurofen Forte contains approximately 25.1 mg (1.09 mmol) sodium, which should be taken into account when prescribing the drug to patients who are indicated for a low diet. sodium content.
Use during pregnancy and lactation. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage, congenital heart defects, or gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular defects increased from 1 to 1.5%. The risk is believed to increase with increasing dose and duration of therapy. In animals, the use of prostaglandin synthesis inhibitors led to an increase in the incidence of pre- and post-implantation miscarriages and embryo/fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with prostaglandin synthesis inhibitors during organogenesis.
Nurofen should not be taken in the first two trimesters of pregnancy unless absolutely necessary. If Nurofen is used by a woman who is trying to become pregnant, or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest period. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose the following risks:
- for the fetus: cardiopulmonary toxicity (characterized by premature closure of the ductus arteriosus and pulmonary hypertension); impaired renal function, which can progress to renal failure accompanied by oligohydramnios;
- for mother and newborn, at the end of pregnancy: possible increase in bleeding time, antiplatelet effect, which can develop even at very low doses; inhibition of uterine contractions, which leads to a delay or increase in the duration of labor.
Thus, Nurofen is contraindicated in the third trimester of pregnancy.
In limited studies, ibuprofen has been found in breast milk at very low concentrations, so it is unlikely to adversely affect a breastfed baby.
Children. Nurofen is not used in children weighing 20 kg and under the age of 6 years. Nurofen Forte is not prescribed to children under 12 years of age.
The ability to influence reaction speed when driving vehicles or working with other mechanisms. When used in accordance with the recommended doses and duration of treatment, the drug does not affect the reaction rate when driving vehicles or operating other mechanisms. Patients who experience dizziness, drowsiness, disorientation, or visual disturbances while taking NSAIDs should not drive or operate machinery.
Interactions
In general, caution should be exercised when using NSAIDs in combination with other drugs that may increase the risk of developing gastrointestinal ulcers, gastrointestinal bleeding, or worsening kidney function.
Ibuprofen, like other NSAIDs, should not be used in combination with:
acetylsalicylic acid, since this may increase the risk of adverse reactions, unless acetylsalicylic acid (dose not exceeding 75 mg/day) was prescribed by a doctor.
Experimental data indicate that, when used concomitantly, ibuprofen can competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation. Although there is uncertainty regarding the extrapolation of these data to the clinical situation, the possibility cannot be ruled out that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With unsystematic use of ibuprofen, such a clinically significant effect is considered unlikely;
Other NSAIDs, including selective COX-2 inhibitors: Concomitant use of two or more NSAIDs should be avoided as this may increase the risk of adverse reactions.
Ibuprofen should be used with caution in combination with:
anticoagulants: NSAIDs can enhance the therapeutic effect of anticoagulants such as warfarin;
Antihypertensives and diuretics: NSAIDs may reduce the effect of these medications. In some patients with impaired renal function (eg, those with dehydration or the elderly with impaired renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit COX may lead to a further deterioration of renal function, including possible acute renal failure, which usually occurs reversible nature. These interactions should be considered in patients using coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If treatment is necessary, the patient should be adequately hydrated and the need to monitor renal function at the beginning of combined treatment, as well as at certain intervals thereafter, should be taken into account. Diuretics may increase the risk of nephrotoxicity from NSAIDs;
GCS may increase the risk of ulcers and bleeding in the gastrointestinal tract;
lithium: there is evidence of a potential increase in plasma lithium levels;
methotrexate: there is evidence of a potential increase in plasma levels of methotrexate;
Zidovudine: An increased risk of hematological toxicity is known with the combined use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia in the case of concomitant treatment with zidovudine and ibuprofen;
cardiac glycosides: NSAIDs can increase cardiac dysfunction, reduce glomerular filtration function of the kidneys and increase the level of glycosides in the blood plasma;
antiplatelet agents and selective serotonin reuptake inhibitors: the risk of gastrointestinal bleeding increases;
cyclosporine: increased risk of nephrotoxicity;
tacrolimus: there may be an increased risk of nephrotoxicity with simultaneous use of NSAIDs and tacrolimus;
mifepristone: NSAIDs should not be used earlier than 8-12 days after using mifepristone, as they reduce its effectiveness;
quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolone antibiotics concomitantly may be at increased risk of seizures.
Overdose
Most reported overdose cases have been asymptomatic. the risk of symptoms occurs at ibuprofen doses above 80–100 mg/kg body weight. use of the drug in children at a dose of 400 mg/kg may cause symptoms of intoxication. in adults, the dose effect is less pronounced. t½ in case of overdose is 1.5–3 hours.
Symptoms Symptoms of overdose occur within 4 hours after use. In most patients, use of a clinically significant amount of NSAIDs caused mild overdose symptoms, including nausea, vomiting, epigastric pain, or less commonly, diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. With more severe poisoning, toxic damage to the central nervous system is possible in the form of vertigo, dizziness, lethargy, drowsiness, and sometimes agitation, ataxia, disorientation or coma. Sometimes patients develop seizures. In severe poisoning, hyperkalemia, metabolic acidosis, and an increase in the prothrombin time/international normalized ratio (probably due to interaction with coagulation factors circulating in the bloodstream) may occur. In rare cases, moderate to severe symptoms have been observed, such as acute renal failure, liver damage, hypotension, hypothermia, cyanosis, dyspnea/acute respiratory syndrome and short-term episodes of apnea (in children after using large amounts of the drug). In patients with asthma, an exacerbation of the disease may occur. Nystagmus, blurred vision and loss of consciousness are possible.
Treatment. There is no specific antidote. Treatment should be symptomatic and supportive, including maintaining the airway and monitoring cardiac and vital signs until the condition returns to normal. When using small amounts of the drug (50 mg/kg), fluid intake is recommended to minimize gastrointestinal disorders. When using large quantities, oral administration of activated charcoal or gastric lavage is recommended if no more than 1 hour has passed since the patient took a potentially toxic dose of the drug and the patient has not used an amount of the drug that poses a threat to life. If ibuprofen has already been absorbed, alkaline agents can be used to promote the excretion of acidic ibuprofen in the urine. The benefit of forced diuresis, hemodialysis and hemoperfusion has not been proven, since ibuprofen has a high degree of binding to plasma proteins. For frequent or prolonged seizures, treatment should be carried out with intravenous diazepam or lorazepam. In case of asthma, bronchodilators should be used.
Adverse reactions and overdose
If Nurofen is used for painful periods, toothache or fever for several days, then no adverse reactions should occur. With prolonged use, adverse reactions may occur:
- from the digestive system: stomach ulcer, constipation, anorexia, indigestion, pain in the mouth, hepatitis;
- from the central nervous system: headache, lethargy, drowsiness, stress, emotionality, insomnia;
- from the cardiovascular system: increased blood pressure, heart failure;
- from the senses: the appearance of tinnitus, deterioration of vision and hearing, swelling of the eyelids;
- from the hematopoietic system: leukopenia, anemia;
- from the respiratory system: bronchospasm, shortness of breath.
Other effects include allergies such as urticaria, angioedema, itching and excessive sweating.
If Nurofen is taken continuously for a long time, ulceration of the gastric mucosa may occur and bleeding may begin.
In case of overdose, a delayed reaction, drowsiness, stress, headache, and high blood pressure appear.
If the permissible dose is exceeded, you need to rinse your stomach, drink activated charcoal and engage in symptomatic therapy.
Note!
Description of the drug Nurofen forte table. p/o 400 mg No. 12 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
