Nurofen for children rectal suppositories 60mg N10
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Active ingredients
Ibuprofen
Release form
Suppositories
Composition
Active ingredient: ibuprofen. Concentration of active ingredient (mg): 60 mg
Pharmacological effect
Absorption - high, connection with plasma proteins (mainly albumin) - more than 90%. A high degree of protein binding results in a relatively low volume of distribution (0.1 L / kg). Although ibuprofen is actively associated with albumin, it does not affect drug interactions. The time to reach maximum plasma concentration Ttah - 1-2 hours. The half-life is 2 hours. In the elderly (over 65 years), the half-life of the drug is increased, the total clearance is reduced. According to some data, babies aged 6–18 months have a higher Tmax (3 hours). It is believed that in children the half-life of ibuprofen does not differ significantly from the value established for adults. Eating slows down the absorption of ibuprofen, but does not reduce its bioavailability. When taken with food, Tmax is increased by 30-60 minutes compared with fasting and is 1.5-3 hours. Ibuprofen slowly penetrates into the cavity of the joints, is retained in the synovial tissue, creating in it greater concentrations than in the plasma; The maximum concentration is observed after 5-6 hours after administration. Cerebrospinal fluid shows lower concentrations of ibuprofen compared to plasma. After absorption, about 60% of the pharmacologically inactive R-form slowly transforms into the active S-form in the gastrointestinal tract and liver. It is metabolized in the liver to form 4 metabolites. Excreted by the kidneys (70-90% of the administered dose in the form of ibuprofen and its metabolites; in unchanged form, no more than 1%) and, to a lesser extent, with bile (less than 2%). Excretion of metabolites with urine usually ends 24 hours after the last dose. The total excretion of ibuprofen and its metabolites in the urine is linearly dependent on the dosage. At the age of 2 months, the kidneys are well developed enough to cope with the elimination of ibuprofen by glomerular filtration. The study, which included 49 children aged 3 months to 12 years, showed no age-dependent differences in the rate of absorption and elimination of ibuprofen.
Pharmacokinetics
The drug belongs to nonsteroidal anti-inflammatory drugs (NSAIDs). Nurofen has anesthetic, antipyretic and anti-inflammatory effect. Indiscriminately blocks TsOG1 and TsOG2. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. A decrease in temperature during fever begins 30 minutes after ingestion, its maximum effect is manifested after 3 hours. The leading analgesic mechanism is the reduction of prostaglandin production of classes E, F and I, biogenic amines, which leads to the prevention of the development of hyperalgesia at the level of changes in the sensitivity of nociceptors. The analgesic effect is most pronounced for inflammatory pain. The analgesic effect is felt within 15 minutes after taking ibuprofen. Anti-inflammatory effect due to inhibition of cyclooxygenase (COX) activity. As a result, the synthesis of prostaglandins in inflammatory foci. This leads to a decrease in the secretion of inflammatory mediators and a decrease in the activity of the exudative and proliferative phases of the inflammatory process.
Indications
For children from 3 months of age to 2 years as an antipyretic in infectious and inflammatory diseases and conditions accompanied by fever, including: acute respiratory diseases, influenza, childhood infections, other infectious and inflammatory diseases and post-vaccination reactions. As an analgesic for pain syndrome of weak or moderate intensity, including for: toothache, headache, migraine, neuralgia, ear pain, sore throat, pain during sprains, muscle pain, rheumatic pain, pain in joints and other types of pain. The drug is recommended for use in case of oral medication is not possible, or in the presence of vomiting. The drug is intended for symptomatic therapy, reduction of pain and inflammation at the time of use, it does not affect the progression of the disease.
Contraindications
Have a history of hypersensitivity reactions (asthma, bronchoconstriction, rhinitis, rhinosinusitis, recurrent nasal polyposis or paranasal sinuses, angioedema, urticaria) in response to the use of aspirin or other NSAIDs, bleeding or perforation, gastrointestinal ulcer history provoked NSAIDs, erosive - ulcerative diseases of the gastrointestinal tract (includingpeptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding), severe liver failure or liver disease in the active phase, severe renal insufficiency (QC less than 30 mlmin), progressive kidney disease, confirmed hyperkalemia, decompensated heart failure, the period after coronary artery bypass surgery, n blood clotting disorders (including hemophilia, lengthening of bleeding time, bleeding tendency, hemorrhagic diathesis), III trimester of pregnancy, baby’s body weight up to 6 kg, proctitis, intracranial hemorrhage, hypersensitivity to ibuprofen or any of the components included in composition of the drug. Precautions should be prescribed the drug while taking other NSAIDs. History of a single episode of gastric 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). severe somatic diseases. systemic lupus erythematosus or mixed connective tissue disease (Sharpe syndrome) - an increased risk of aseptic meningitis. renal failure, including during dehydration (CC 30-60 mlmin), fluid retention and edema. Hepatic insufficiency. hypertension or heart failure. cerebrovascular diseases. Dyslipidemiigiperlipidemii. Diabetes mellitus. Diseases of peripheral arteries. Blood diseases of unknown etiology (leukopenia, anemia). concomitant use of other drugs that may increase the risk of ulcers or bleeding, in particular, GCS for oral administration (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel). in the I and II trimesters of pregnancy, during breastfeeding. elderly patients.
Precautionary measures
Nurofen is prescribed with caution in patients with heart failure, arterial hypertension, blood clotting disorders, and renal and / or liver function disorders. Care should be taken when using the drug in patients with bronchial asthma and other obstructive pulmonary diseases due to the risk of bronchospasm. Patients with diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease) should be carefully prescribed NSAIDs due to the possible exacerbation of these diseases. With caution, the drug is prescribed for elderly patients, since they more often have adverse side effects on NSAIDs, mainly gastrointestinal bleeding and perforation, which can lead to a sharp deterioration. Patients with gastrointestinal toxicity in history, especially elderly patients, should report any unusual abdominal symptom (especially gastrointestinal bleeding), especially if the symptom is observed at the initial stage of taking the drug. If patients with gastrointestinal bleeding develop on the background of the drug, it is urgent to stop taking the drug. The simultaneous use of Nurofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Systemic lupus erythematosus, as well as mixed connective tissue diseases contribute to an increased risk of aseptic meningitis. There is some evidence that drugs that inhibit the synthesis of cyclogenase / prostaglandins can cause impaired fertility in women, affecting ovulation. This phenomenon is reversible with drug withdrawal. The drug should not be administered to patients with fructose intolerance, with the syndrome of glucose-galactose malabsorption or sucrase-isomaltase deficiency. Two Nurofen pills contain 25.3 mg of sodium, which should be taken into account in patients who are on a controlled sodium diet. During long-term treatment, it is necessary to control the picture 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. Patients should refrain from all activities related to driving and working with moving machinery, as well as from other potentially dangerous activities related to concentration and increased speed of psychomotor reactions. During the period of treatment should refrain from the use of alcoholic beverages. When used in children aged 6 to 12 years, it should be borne in mind that pills can not be divided, and therefore can be used only in those children who have a single dose of at least 1 tablet.
Use during pregnancy and lactation
Use of the drug during pregnancy is possible only under the supervision of a physician. Use of the drug during the I and II trimesters is undesirable, but possible with caution. If Nurofen is used by a woman who is planning a pregnancy, or by a woman in the I and II trimester of pregnancy, then the smallest effective dose and short periods of treatment should be chosen. Use during the III trimester is contraindicated. The use of the drug during lactation is not recommended. In a number of studies, ibuprofen has been found in breast milk at very low concentrations, and its effect on infants is unlikely.
Dosage and administration
Nurofen for children suppositories are specially designed for children. The drug is used rectally. With fever and pain, the dose of the drug depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mgkg of body weight of the child with intervals between doses of the drug 6-8 hours. Children at the age of 3-9 months (body weight 6-8 kg) are prescribed 1 supp. (60 mg) up to 3 times, but not more than 180 mg days. Children aged from 9 months to 2 years (body weight 8-12 kg) are assigned 1 supp. (60 mg) up to 4 times, not more than 240 mg days. The duration of treatment is not more than 3 days. Do not exceed the specified dose. If during the use of the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older) the symptoms persist or worsen, it is necessary to stop treatment and consult a doctor. In postimmunization fever, children under the age of 1 year are prescribed 1 supp. (60 mg).if necessary, after 6 h, you can enter another 1 supp. (60 mg). Do not use more than 2 supp. (120 mg) for 24 hours.
Side effects
The risk of side effects can be minimized if the drug is used for a short time, at the minimum effective dose necessary to eliminate the symptoms. Side effects are predominantly dose dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and long-term use may cause other adverse reactions. The frequency of adverse reactions was estimated based on the following criteria: very often (≥110), often (from ≥1100 to less than 110), infrequently (from ≥11000 to less than 1100), rarely (from ≥110 000 to less than 11000), very rarely (less than 110 000), the frequency is unknown (frequency estimates are not available). On the part of the hematopoietic system: very rarely - hematopoietic 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, bleeding from the nose and subcutaneous hemorrhages, hemorrhages and hemorrhages of unknown etiology. On the part of the immune system: rarely - 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 (itch, urticaria, purpura , Quincke’s edema, exfoliative and bullous dermatosis, including toxic epidermal necrolysis, 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, hypotension (anaphylaxis, angioedema, or severe anaphylactic shock). On the part of the gastrointestinal tract: infrequently - abdominal pain, nausea, dyspepsia. rarely - diarrhea, flatulence, constipation, vomiting. very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, ulcerative stomatitis, gastritis.unknown frequency - exacerbation of ulcerative colitis and Crohn's disease. On the part of the hepatobiliary system: very rarely - abnormal liver function, hepatitis. On the part of the urinary system: very rarely - acute renal failure, especially with prolonged use, in combination with increased levels of urea in the blood plasma and the appearance of edema, papillary necrosis. From the nervous system: infrequently - headache. very rarely, aseptic meningitis (in patients with autoimmune diseases). Since the cardiovascular system: the frequency is unknown - heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (eg, myocardial infarction, stroke), increased blood pressure. On the part of the respiratory system: the frequency is unknown - bronchial asthma, bronchospasm, shortness of breath. Other: very rarely - edema, including peripheral. Laboratory indicators: hematocrit or hemoglobin may decrease. bleeding time may increase. plasma glucose concentration may decrease. QC may decrease. plasma creatinine concentration may increase. Hepatic transaminase activity may increase. If side effects occur, the patient should stop taking the drug and consult a doctor.
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, metabolic acidosis, coma, acute renal and hepatic failure, gastrointestinal bleeding, low blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, arrest respiration, increased prothrombin time, seizures are rarely possible. Treatment: during the first hour after taking the drug, gastric lavage and taking activated carbon. Alkaline drink, forced diuresis, and symptomatic therapy are also recommended. In the case of frequent or prolonged seizures, it is necessary to use anticonvulsant drugs (diazepam or lorazepam intravenously).
Interaction with other drugs
It is not recommended to take NUROFEN pills with acetylsalicylic acid (aspirin) at the same time, if taking low-dose aspirin (not exceeding 75 mg per day) is not recommended by the doctor, since it increases the risk of adverse side effects.When taken simultaneously, ibuprofen can inhibit the effects of low doses of aspirin on platelet aggregation. You should also avoid taking two or more NSAIDs at the same time, including selective cyclooxygenase-2 inhibitors, as this may increase the risk of side effects. When administered with anticoagulant and thrombolytic drugs (alteplazy, streptokinase, urokinase), the risk of bleeding increases at the same time. Cefamendol, cefaperazon, cefotetan, valproic acid, plicamycin, increase the incidence of hypoprothrombinemia. Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increased risk of nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects. Do not use NSAIDs for 8-12 days after taking mifepristone, as NSAIDs can reduce the effect of mifepristone. At the same time taking NSAIDs and tacrolimus may increase the risk of nephrotoxicity. At the same time taking NSAIDs and zidovudine increases the risk of hematological toxicity. Patients taking NSAIDs and quinolones, increases the risk of seizures. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic action. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics. Strengthens the side effects of mineral corticosteroids, glucocorticosteroids, estrogens, ethanol. Enhances the effect of oral hypoglycemic drugs, sulfonylurea derivatives and insulin. Antacids and colestyramine reduce absorption. Increases blood concentration of digoxin, lithium preparations, methotrexate.Caffeine enhances the analgesic effect.