NUROFEN FOR CHILDREN
◊ Oral suspension (orange) white or almost white in color, syrupy consistency, with a characteristic orange odor.
Excipients: polysorbate 5 mg, glycerol - 0.5 mg, maltitol syrup - 1.625 mg, sodium saccharinate - 10 mg, citric acid - 20 mg, sodium citrate - 25.45 mg, xanthan gum - 37.5 mg, sodium chloride - 5.5 mg, domiphene bromide - 0.5 mg, orange flavor 2M.5 mg, purified water - up to 5 ml.
Table of contents:
- NUROFEN FOR CHILDREN
- Nurofen ® for Children
- Active substance:
- Content
- Pharmacological group
- Nosological classification (ICD-10)
- 3D images
- Compound
- Description of the dosage form
- pharmachologic effect
- Pharmacodynamics
- Pharmacokinetics
- Indications of the drug Nurofen ® for children
- Contraindications
- Use during pregnancy and breastfeeding
- Side effects
- Interaction
- Directions for use and doses
- Overdose
- special instructions
- Release form
- Manufacturer
- Conditions for dispensing from pharmacies
- Storage conditions for Nurofen ® for children
- Shelf life of Nurofen ® for children
- Synonyms of nosological groups
- Prices in Moscow pharmacies
- Nurofen for children - official instructions for use
- Nurofen for children: instructions for use
- Release form and composition
- pharmachologic effect
- Indications for use
- Contraindications for use
- Directions for use and doses
- Side effects
- special instructions
- Overdose
- Analogues of Nurofen for children
- Terms and conditions of storage
- Nurofen children's price
100 ml - polyethylene terephthalate bottles (1) complete with a dosing syringe - cardboard boxes.
150 ml - polyethylene terephthalate bottles (1) complete with a dispenser syringe - cardboard boxes.
200 ml - polyethylene terephthalate bottles (1) complete with a dispenser syringe - cardboard boxes.
◊ Oral suspension (strawberry) white or almost white in color, syrupy consistency, with a characteristic strawberry odor.
Excipients: polysorbate 5 mg, glycerol - 0.5 mg, maltitol syrup - 1.625 mg, sodium saccharinate - 10 mg, citric acid - 20 mg, sodium citrate - 25.45 mg, xanthan gum - 37.5 mg, sodium chloride - 5.5 mg, domiphene bromide - 0.5 mg, strawberry flavor E - 12.5 mg, purified water - up to 5 ml.
100 ml - polyethylene terephthalate bottles (1) complete with a dosing syringe - cardboard boxes.
150 ml - polyethylene terephthalate bottles (1) complete with a dispenser syringe - cardboard boxes.
200 ml - polyethylene terephthalate bottles (1) complete with a dispenser syringe - cardboard boxes.
NSAIDs. It has analgesic, antipyretic and anti-inflammatory effects.
The mechanism of action of ibuprofen, a derivative of propionic acid, is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks COX-1 and COX-2, as a result of which it inhibits the synthesis of prostaglandins. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect is most pronounced for inflammatory pain. The effect of the drug lasts up to 8 hours.
Suction and distribution
Absorption is high, quickly and almost completely absorbed from the gastrointestinal tract. After taking the drug on an empty stomach in adults, ibuprofen is detected in the blood plasma after 15 minutes; Cmax of ibuprofen in the blood plasma is reached after 60 minutes. Taking the drug with food can increase the time to reach Cmax by up to 1-2 hours.
Binding to blood plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma.
In limited studies, ibuprofen has been found in breast milk at very low concentrations.
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.
It is excreted by the kidneys (unchanged - no more than 1%) and, to a lesser extent, with bile. T 1/2 – 2 hours.
For children from 3 months to 12 years of age as an antipyretic for infectious and inflammatory diseases and conditions accompanied by an increase in body temperature, incl. at:
— acute respiratory diseases;
— other infectious and inflammatory diseases and post-vaccination reactions.
As an analgesic for pain of mild or moderate intensity, incl. at:
- pain with sprains;
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs;
- a history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs;
- erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, 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);
- severe liver failure or active liver disease;
- severe renal failure (creatinine clearance <30 ml/min);
— the period after coronary artery bypass grafting;
- cerebrovascular or other bleeding;
— hemophilia and other bleeding disorders (including hypocoagulation);
— III trimester of pregnancy;
— child’s body weight up to 5 kg;
- hypersensitivity to ibuprofen or any of the components included in the drug.
with caution when using other NSAIDs simultaneously; a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history (possible development of bronchospasm); severe somatic diseases; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; renal failure, incl. for dehydration (KKml/min), fluid retention and edema; liver failure; arterial hypertension and/or heart failure; cerebrovascular diseases; dyslipidemia/hyperlipidemia; diabetes mellitus; peripheral arterial diseases; blood diseases of unknown etiology (leukopenia, anemia); simultaneous use of other drugs that may increase the risk of ulcers or bleeding, in particular, corticosteroids 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 1st and 2nd trimester of pregnancy, during breastfeeding, in elderly patients.
Nurofen for children is a drug developed specifically for children. The drug is intended for short-term use only.
The drug is taken orally. Patients with hypersensitivity of the stomach are recommended to take the drug with meals.
The dose depends on the age and body weight of the child.
For fever and pain, the maximum daily dose should not exceed 30 mg/kg body weight with intervals between doses of the drug of 6-8 hours.
Do not exceed the indicated dose.
The duration of treatment is no more than 3 days.
If, when using the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), symptoms persist or worsen, you should stop treatment and consult a doctor.
For fever after immunization in children under 6 months of age, the drug is prescribed at a dose of 50 mg (2.5 ml); if necessary, after 6 hours the drug can be re-administered at the same dose.
Do not use more than 100 mg (5 ml) within 24 hours.
Rules for using a measuring syringe
The suspension should be shaken thoroughly before use.
For precise dosing of the suspension, a measuring syringe is included with the bottle. 5 ml of the drug contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.
1. Insert the syringe tightly into the neck of the bottle.
2. Turn the bottle upside down and smoothly pull the plunger down, drawing the suspension into the syringe to the desired mark.
3. Return the bottle to its original position and remove the syringe, carefully turning it.
4. Place the syringe in the child’s mouth and slowly press the plunger, smoothly releasing the suspension.
After use, rinse the syringe in warm water and dry it out of the reach of the child.
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose required to eliminate 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. When treating chronic conditions and with long-term use, other adverse reactions may occur.
The incidence of adverse reactions was assessed 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/to <1/1000), very rare (<1/10,000), frequency unknown (no data available to estimate frequency).
From 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, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
From the immune system: infrequently - hypersensitivity reactions (nonspecific allergic reactions and anaphylactic reactions), reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura , Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely - severe hypersensitivity reactions, incl. swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).
From 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; frequency unknown - exacerbation of ulcerative colitis and Crohn's disease.
From the liver and biliary tract: very rarely - liver dysfunction.
From the urinary system: very rarely - 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, papillary necrosis.
From the nervous system: infrequently - headache; very rarely - aseptic meningitis (in patients with autoimmune diseases).
From the cardiovascular system: frequency unknown - heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.
From the respiratory system: frequency unknown - bronchial asthma, bronchospasm, shortness of breath.
Other: very rarely - swelling, incl. peripheral.
Laboratory parameters: 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, you should stop taking the drug and consult a doctor.
In children, overdose symptoms may occur after taking a dose exceeding 400 mg/kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. T 1/2 of the drug in case of overdose is 1.5-3 hours.
Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, 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 may develop. In patients with bronchial asthma, exacerbation of this disease is possible.
The simultaneous use of ibuprofen with the drugs listed below should be avoided.
Acetylsalicylic acid: with the exception of acetylsalicylic acid in low doses (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 acetylsalicylic acid in small doses as an antiplatelet agent is possible after starting ibuprofen).
Other NSAIDs, including 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 concomitantly with the following medications.
Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.
Antihypertensive drugs (ACE inhibitors and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
Cardiac glycosides: simultaneous administration 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.
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 when NSAIDs are administered concomitantly with cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.
Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase.
Zidovudine: Concomitant use of NSAIDs and zidovudine may result in 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 be increased.
It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.
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.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
During the treatment period, ethanol intake is not recommended.
The drug is contraindicated in patients with fructose intolerance, because contains maltitol.
Nurofen for children can be used for children with diabetes mellitus, because. the drug does not contain sugar.
Does not contain dyes.
Patients with renal failure should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys.
Patients with arterial hypertension, incl. history, and/or chronic heart failure, you should consult your doctor before using the drug, since the drug may cause fluid retention, increased blood pressure and edema.
Impact on the ability to drive vehicles and operate machinery
Patients who experience dizziness, drowsiness, lethargy, or blurred vision while taking ibuprofen should avoid driving or operating machinery.
The use of the drug is contraindicated in the third trimester of pregnancy. Before using the drug in the first and second trimesters of pregnancy or during breastfeeding, you should consult your doctor. There is evidence that ibuprofen can pass into breast milk in small quantities without any adverse effects on the health of the nursing infant.
Contraindicated in severe renal failure (creatinine clearance <30 ml/min).
Caution should be exercised when prescribing a drug for renal failure, incl. for dehydration (KKml/min), fluid retention and edema.
Contraindicated in severe liver failure or active liver disease.
Use with caution in case of liver failure.
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.
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Nurofen ® for Children
Active substance:
Content
Pharmacological group
Nosological classification (ICD-10)
3D images
Compound
Description of the dosage form
White or almost white suspension of syrupy consistency with an orange or strawberry odor.
pharmachologic effect
Pharmacodynamics
The mechanism of action of ibuprofen, a derivative of propionic acid from the NSAID group, is due to inhibition of the synthesis of PG - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks COX-1 and COX-2, as a result of which it inhibits the synthesis of PG. In addition, ibuprofen reversibly inhibits platelet aggregation. It has analgesic, antipyretic and anti-inflammatory effects. The analgesic effect is most pronounced for inflammatory pain. The effect of the drug lasts up to 8 hours.
Pharmacokinetics
Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract (binding with blood plasma proteins - 90%). After taking the drug on an empty stomach in adults, ibuprofen is detected in the blood plasma after 15 minutes, the Cmax of ibuprofen in the blood plasma is achieved after 60 minutes. Taking the drug with food can increase T max up to 1–2 hours. T 1/2 - 2 hours. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 50% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Metabolized in the liver. No more than 1% is excreted unchanged by the kidneys and, to a lesser extent, with bile.
In clinical studies, ibuprofen was detected in very low concentrations in breast milk.
Indications of the drug Nurofen ® for children
For children from 3 months to 12 years:
as a symptomatic treatment as an antipyretic for acute respiratory infections (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature;
as a symptomatic analgesic for pain of mild or moderate intensity, incl. toothache, headache, migraine, neuralgia, earache, sore throat, sprain pain, muscle pain, rheumatic pain, joint pain and other types of pain.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.
Contraindications
hypersensitivity to ibuprofen or any of the components included in the drug;
complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs;
a history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs;
erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, 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);
severe liver failure or active liver disease;
decompensated heart failure, the period after coronary artery bypass grafting;
cerebrovascular or other bleeding;
hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;
pregnancy (third trimester);
child's body weight up to 5 kg.
With caution: in the presence of the conditions specified in this section, you should consult a doctor before using the drug - simultaneous use of other NSAIDs, a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of Helicobacter pylori , ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history - bronchospasm may develop; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; renal failure, incl. with dehydration (Cl creatinine 30–60 ml/min), fluid retention and edema, liver failure, arterial hypertension and/or heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, blood diseases of unknown etiology (leukopenia, anemia); simultaneous use of other drugs that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine , sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I–II trimester), breastfeeding period, old age.
Use during pregnancy and breastfeeding
The use of the drug is contraindicated in the third trimester of pregnancy. Before using the drug in the first and second trimesters of pregnancy or during breastfeeding, you should consult your doctor. There is evidence that ibuprofen can pass into breast milk in small quantities without any adverse effects on the health of the nursing infant.
Side effects
The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose required to eliminate 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. When treating chronic conditions and with long-term use, other adverse reactions may occur.
The incidence of adverse reactions was assessed based on the following criteria; very often (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000); frequency unknown (no frequency estimates available).
From the blood and lymphatic system: very rare - 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, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
From the immune system: infrequently - hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rare - severe hypersensitivity reactions, incl. swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).
From 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; frequency unknown - exacerbation of ulcerative colitis and Crohn's disease.
From the liver and biliary tract: very rarely - liver dysfunction.
From the kidneys and urinary tract: very rarely - 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, papillary necrosis.
From the nervous system: infrequently - headache; very rarely - aseptic meningitis (in patients with autoimmune diseases).
From the cardiovascular system: frequency unknown - heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.
From the respiratory system and mediastinal organs: frequency unknown - bronchial asthma, bronchospasm, shortness of breath.
Other: very rarely - swelling, incl. peripheral.
Laboratory values: hematocrit or Hb (may decrease); bleeding time (may increase); plasma glucose concentration (may decrease); creatinine clearance (may decrease); plasma creatinine concentration (may increase); liver transaminase activity (may increase). If side effects occur, you should stop taking the drug and consult a doctor.
Interaction
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, incl. selective COX-2 inhibitors: 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.
Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
GCS: 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 glomerular filtration rate 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 when NSAIDs are administered concomitantly with cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.
Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase.
Zidovudine: Concomitant use of NSAIDs and zidovudine may result in 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 be increased.
Directions for use and doses
Inside. Nurofen ® for children is a suspension specially designed for children.
Patients with hypersensitivity of the stomach are recommended to take the drug with meals.
For short term use only.
Read the instructions carefully before taking the drug.
Shake the bottle thoroughly before use. To accurately measure the dose of the drug, a convenient measuring syringe is included. 5 ml of the drug contain 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.
Using a measuring syringe
Insert the measuring syringe tightly into the neck of the bottle. Turn the bottle upside down and smoothly pull the plunger down, drawing the suspension into the syringe to the desired mark. Return the bottle to its original position and remove the syringe, carefully turning it. Place the syringe in the oral cavity and slowly press the plunger, smoothly releasing the suspension.
After use, rinse the syringe in warm water and dry it out of the reach of the child.
Fever (fever) and pain
The dosage for children depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg/kg with intervals between doses of the drug of 6–8 hours. Children aged 3–6 months (child weight from 5 to 7.6 kg) - 2.5 ml (50 mg) up to 3 once every 24 hours, no more than 7.5 ml (150 mg) per day.
Children aged 6–12 months (child weight 7.7–9 kg): 2.5 ml (50 mg) up to 3–4 times within 24 hours, no more than 10 ml (200 mg) per day. Children aged 1–3 years (child weight 10–16 kg): 5 ml (100 mg) up to 3 times within 24 hours, no more than 15 ml (300 mg) per day.
Children aged 4–6 years (child weight 17–20 kg): 7.5 ml (150 mg) up to 3 times within 24 hours, no more than 22.5 ml (450 mg) per day.
Children aged 7–9 years (child weight 21–30 kg): 10 ml (200 mg) up to 3 times within 24 hours, no more than 30 ml (600 mg) per day.
Children aged 10–12 years (child weight 31–40 kg): 15 ml (300 mg) up to 3 times within 24 hours, no more than 45 ml (900 mg) per day.
The duration of treatment is no more than 3 days. Do not exceed the indicated dose.
If symptoms persist or worsen after taking the drug for 24 hours (in children aged 3–5 months) or for 3 days (in children aged 6 months and older), you should stop treatment and consult a doctor.
Children under 6 months of age: 2.5 ml (50 mg) of the drug. If necessary, another 2.5 ml (50 mg) after 6 hours. Do not use more than 5 ml (100 mg) within 24 hours.
Overdose
In children, overdose symptoms may occur after taking a dose exceeding 400 mg/kg. In adults, the dose-dependent effect of overdose is less pronounced. T1 /2 of the drug in case of overdose is 1.5–3 hours.
Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased PT, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible.
Treatment: symptomatic, with mandatory maintenance of airway patency, monitoring of ECG and vital signs until the patient’s condition is normalized.
Oral use of activated charcoal or gastric lavage is recommended within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be treated with IV diazepam or lorazepam. If bronchial asthma worsens, the use of bronchodilators is recommended.
special instructions
It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.
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 (Hb determination), and a stool test for occult blood.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, ethanol intake is not recommended. The drug is contraindicated in patients with fructose intolerance, because contains maltitol.
Nurofen ® for children can be used in children with diabetes mellitus, because the drug does not contain sugar. Does not contain dyes.
Patients with renal failure should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys.
Patients with hypertension, incl. history and/or CHF, you should consult your doctor before using the drug, since the drug can cause fluid retention, increased blood pressure and edema.
Impact on the ability to drive vehicles and other potentially dangerous mechanisms. Patients who experience dizziness, drowsiness, lethargy, or blurred vision while taking ibuprofen should avoid driving or operating machinery.
Release form
Oral suspension (orange, strawberry), 100 mg/5 ml. PET bottle with LDPE or polypropylene cap and liner, containing 100 ml, 150 ml or 200 ml of suspension.
Each bottle is complete with a dispenser syringe and packed in a cardboard box.
Manufacturer
Reckitt Benckiser Healthcare Limited, Dansome Lane, Hull, East Yorkshire, HY8 7DS, UK.
Reckitt Benckiser Healthcare India Limited, Khasra No. 701/534, Sandholi, Baddi - Nalagar Road, Baddi, Solan (Himachal Pradesh), India (for oral suspension (orange).
Legal entity in whose name the registration certificate is issued: Reckitt Benckiser Healthcare International Ltd., Thane Road, Nottingham, NG90 2DB, UK.
Representative in Russia/organization receiving consumer complaints: Reckitt Benckiser Healthcare LLC, Russia, Moscow, st. Kozhevnicheskaya, 14.
Tel.: (calls within Russia are free).
Conditions for dispensing from pharmacies
Storage conditions for Nurofen ® for children
Keep out of the reach of children.
Shelf life of Nurofen ® for children
Do not use after the expiration date stated on the package.
Synonyms of nosological groups
Prices in Moscow pharmacies
The information is intended solely for comparing prices in stationary pharmacies operating in accordance with Article 55 of the Federal Law “On the Circulation of Medicines” dated April 12, 2010 N 61-FZ.
oral suspension 100 mg/5 ml strawberry(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
suspension for oral administration 100 mg/5 ml orange(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
oral suspension 100 mg/5 ml strawberry(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
oral suspension 100 mg/5 ml strawberry(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
suspension for oral administration 100 mg/5 ml orange(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
suspension for oral administration 100 mg/5 ml orange(s), 1 pc.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
rectal suppositories for children 60 mg, 10 pcs.
Reckitt Benckiser Healthcare International Ltd. (Great Britain)
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Opinion of “Doctors of the Russian Federation” about the drug Nurofen ® for children
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Nurofen for children - official instructions for use
on the medical use of the drug NUROFEN FOR CHILDREN
Trade name: NUROFEN® FOR CHILDREN
Registration number: P No/01
International nonproprietary name (INN) ibuprofen
Dosage form: oral suspension [orange, strawberry]
Description: a suspension of white or almost white color, syrupy consistency with a characteristic orange or strawberry odor.
5 ml of Nurofen® suspension for children contains 100 mg of ibuprofen (active ingredient) and excipients: maltitol syrup, water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharinate, orange flavor 2M16014 or strawberry flavor E, xanthan gum, polysorbate 80, domiphene bromide.
Pharmacotherapeutic group non-steroidal anti-inflammatory drug.
It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action of ibuprofen is due to inhibition of the biosynthesis of prostaglandins - mediators of pain and inflammation. The effect of the drug lasts up to 8 hours.
Nurofen" for children is used from 3 months of life to 12 years as an antipyretic for acute respiratory diseases, influenza, childhood infections, post-vaccination reactions and other infectious and inflammatory diseases accompanied by an increase in body temperature. The drug is used as an analgesic for pain of mild or moderate intensity, including: headaches and toothaches, migraines, neuralgia, pain in the ears and throat, pain with sprains and other types of pain.
Your doctor may also recommend this drug for other indications (in this case, follow your doctor’s recommendations on dosage and dosage regimen).
Nurofen® for children should not be used if:
1. Insert the syringe tightly into the neck of the bottle.
2. Shake the suspension well.
3. Turn the bottle upside down and smoothly pull the plunger down, drawing the suspension into the syringe to the desired level.
4. Return the bottle to its original position and remove the syringe, carefully turning it.
5. Place the syringe in the child’s mouth and slowly press the plunger, smoothly releasing the suspension. After use, rinse the syringe in warm water and dry it out of the reach of the child. Fever (Heat) and pain:
The dosage for children depends on the age and body weight of the child. A single dose is 5-10 mg/kg of the child’s body weight 3-4 times a day. The maximum daily dose should not exceed 30 mg per kg of body weight of the child per day. Children aged 3-6 months (child weight more than 5 kg): 2.5 ml 3 times within 24 hours, no more than 150 mg per day. Children aged 6-12 months (average child weight 6-10 kg): 2.5 ml 3-4 times within 24 hours, no more than 200 mg per day. Children aged 1-3 years (average child weight kg): 5.0 ml 3 times within 24 hours, no more than 300 mg per day. Children aged 4-6 years (average child weight kg): 7.5 ml 3 times within 24 hours, no more than 450 mg per day. Children aged 7-9 years (average child weight kg): 10 ml 3 times within 24 hours, no more than 600 mg per day. Children aged one year (average child weight kg): 15 ml 3 times within 24 hours, no more than 900 mg per day. Warning: Do not exceed the indicated dose.
Post-immunization fever: 2.5 ml syringe for children under 1 year of age, after 1 year, if necessary, another 2.5 ml syringe after 6 hours.
INTERACTION WITH OTHER MEDICINES Simultaneous use of NUROFEN® FOR CHILDREN with anticoagulants may lead to an increase in their effect. Nurofen® for children increases the concentration of digoxin, phenytoin, methotrexate, lithium in the blood plasma when used simultaneously with these drugs. Using Nurofen® for children together with diuretics and antihypertensive drugs reduces their effectiveness. Increases the side effects of mineralocorticosteroids and glucocorticosteroids. SPECIAL INSTRUCTIONS Nurofen® for children can be used in children with diabetes mellitus, because the drug does not contain sugar. Does not contain dyes. RELEASE FORM Oral suspension [orange, strawberry] 100 mg/5 ml. Polyethylene terephthalate bottle with a low-density polyethylene or polypropylene cap and liner, containing 100 ml or 150 ml of suspension. Each bottle, complete with a dispenser syringe, is packaged in a cardboard box along with instructions for use. STORAGE CONDITIONS At a temperature not higher than 25°C. In a dry place. Keep out of the reach of children! SHELF LIFE: 3 years.
Do not use a drug that has expired. HOLIDAY FROM PHARMACIES Without a prescription.
Reckitt Benckiser Healthcare International Ltd. Thane Road, Nottingham, NG90 2DB, UK, manufactured by BSM Ltd, Thane Road, Nottingham, NG2 ZAA, UK. Representative in Russia/address for claims
Reckitt Benckiser Healthcare LLC
Russia, Moscow, Kozhevnicheskaya st., 14
Source: http://medi.ru/instrukciya/nurofen-dlya-detej_7347/
Nurofen for children: instructions for use
Nurofen suspension is a drug belonging to the pharmacological group of non-steroidal anti-inflammatory drugs. It is used for children as an analgesic and antipyretic for elevated body temperature.
Release form and composition
Suspension for oral (inside) use Nurofen has a syrupy consistency, white color, and a characteristic orange or strawberry smell. The main active ingredient of the drug is ibuprofen, its content in 5 ml of suspension is 100 mg. It also includes auxiliary components, which include:
- Lemon acid.
- Xanthan gum.
- Sodium saccharinate.
- Maltitol syrup.
- Glycerol.
- Sodium citrate.
- Domiphen bromide.
- Sodium chloride.
- Orange flavor (2M16014) or strawberry (500244E).
- Purified water.
pharmachologic effect
The main active ingredient of the Nurofen suspension, ibuprofen, has an inhibitory effect on the enzyme cycloxygenase, which catalyzes the reaction of converting arachidonic acid into mediators of the inflammatory reaction, prostaglandins, which are responsible for the development of the inflammatory reaction in tissues, the appearance of pain, and an increase in body temperature. By reducing the concentration of prostaglandins, the analgesic, anti-inflammatory and antipyretic therapeutic effect of the Nurofen suspension is realized.
Data on the rate of absorption, distribution, metabolism and excretion of the active substance Nurofen have not been provided to date.
Indications for use
Taking Nurofen suspension is indicated for a number of pathological processes that are accompanied by an increase in body temperature and the development of pain against the background of an inflammatory reaction:
- Acute respiratory viral infection is a viral infection of the upper respiratory tract with the development of intoxication.
- Influenza is a specific respiratory viral infection caused by the influenza virus, characterized by a moderate to severe course with severe intoxication.
- Various childhood bacterial and viral infections accompanied by fever.
- Post-vaccination reaction of the body, which is characterized by an increase in the child’s body temperature after vaccination.
- Migraine is a paroxysmal headache of moderate intensity.
- Symptomatic headache.
- Toothache of moderate intensity.
- Neuralgia is pain that develops as a result of aseptic (non-infectious) inflammation of the peripheral nerves.
- Pain in the middle ear, throat, bone sinuses of the skull.
- Post-traumatic or postoperative pain of various localizations.
Nurofen suspension is a drug for symptomatic treatment, it helps to lower body temperature, reduce the inflammatory reaction and pain, it does not affect the course of the pathological process and its progression.
Contraindications for use
Taking Nurofen suspension is contraindicated in a number of pathological and physiological conditions, which include:
- Individual intolerance and increased sensitivity of the body to the active substance or auxiliary components of the drug.
- Hypersensitivity to other non-steroidal anti-inflammatory drugs (acetylsalicylic acid, paracetamol).
- The presence of manifestations of the “aspirin triad” syndrome, which is characterized by bronchial asthma, allergic rhinitis, nasal polyposis, which is provoked by taking acetylsalicylic acid and other representatives of non-steroidal anti-inflammatory drugs.
- Pathology of the gastrointestinal tract, which is characterized by the formation of defects in the mucous membrane (erosive gastritis, peptic ulcer of the stomach or duodenum), especially in the stage of clinical and laboratory exacerbation.
- Active gastrointestinal bleeding of any location.
- Inflammatory bowel pathology.
- Pathology of the blood system - hemophilia or hypocoagulation (blood clotting disorder), leukopenia (decreased number of leukocytes in the blood).
- Marked decrease in the functional activity of the kidneys or liver.
- Decreased hearing acuity.
Nurofen suspension should be taken with caution in case of pathology of the liver, kidneys, infection of the stomach with the bacterium Helicobacter pylori, taking indirect anticoagulants (drugs that reduce blood clotting) or other non-steroidal anti-inflammatory drugs, bronchial asthma and urticaria, suffered from a previous peptic ulcer of the stomach or duodenum. Before you start taking Nurofen suspension, you should make sure that there are no contraindications.
Directions for use and doses
Nurofen syrup is a drug developed specifically for use in children. It is applied orally 3-4 times a day, the volume is dosed using a special dispenser syringe. The dosage depends on the child’s body weight and age:
- Age 3-6 months, weight more than 5 kg – 50 mg (2.5 ml), 3 times a day.
- Age from six months to one year, weight 6-10 kg - 50 mg (2.5 ml), 3-4 times a day.
- Age from 1 year to 3 years, weight – 100 mg (5 ml), 3 times a day.
- Age 4-6 years, weight – 150 mg (7.5 ml), 3 times a day.
- Age 7-9 years, weight – 200 mg (10 ml), 3 times a day.
- Age, weightkg – 300 mg (15 ml), 3 times a day.
It is not recommended to exceed the recommended age dosage of Nurofen suspension. The duration of use of the drug to reduce body temperature during fever should not exceed 3 days, to reduce the severity of pain - no more than 5 days. If the symptoms of the pathological process continue to persist, you should consult a doctor. Before taking the Nurofen suspension, you need to shake it, then place the dispenser syringe tightly on the neck of the bottle and draw the required volume of the suspension in a vertical position of the bottle. Then the contents of the dispenser syringe are slowly squeezed into the child’s oral cavity, pressing on the piston. After use, the dispenser syringe should be rinsed with warm water and dried.
Side effects
After taking the Nurofen suspension, it is rarely possible to develop negative reactions from various organs and systems:
- Digestive system - nausea followed by vomiting, pain in the abdomen, with a predominant localization in its upper parts (epigastrium), diarrhea, erosive and ulcerative lesions of the mucous membrane of the structures of the upper parts of the digestive tract, gastrointestinal bleeding.
- Nervous system – headache, periodic dizziness, insomnia, psychomotor agitation.
- Cardiovascular system - increased systemic blood pressure (arterial hypertension), increased heart rate (tachycardia).
- Urinary system - impaired functional activity of the kidneys, reactive inflammation of the bladder (cystitis).
- Blood system and red bone marrow – decrease in the number of red blood cells (anemia), platelets (thrombocytopenia), leukocytes (leukopenia).
- Allergic reactions - skin rash, itching, urticaria (characteristic rash and swelling of the skin, reminiscent of a nettle burn), angioedema (severe swelling of soft tissues with predominant localization in the face and external genitalia), severe necrotic skin lesions (Lyell's syndrome , Stevens-Johnson), bronchospasm (allergic narrowing of the lumen of the bronchi with the development of shortness of breath), anaphylactic shock (severe systemic allergic reaction, which is characterized by a pronounced decrease in systemic blood pressure and multiple organ failure).
If side effects develop after taking Nurofen suspension, its use should be stopped and consult a doctor.
special instructions
Before starting to use Nurofen suspension for children, you should carefully read the instructions for the drug. There are a few special instructions that you need to pay attention to, these include:
- Since the drug is used for children, it does not contain dyes as auxiliary components.
- Nurofen suspension contains sugar, which should be taken into account when using it in children with diabetes.
- The active substance of the drug can interact with drugs from other pharmacological groups, in particular with indirect anticoagulants, methotrexate, glucocorticoids, and weakens the therapeutic effect of diuretics (diuretics) and antihypertensive drugs. In cases of their use, you should warn your doctor.
- The use of the drug in children under 3 months is prohibited.
Nurofen suspension is sold in pharmacies as an over-the-counter drug. If you have any questions regarding its use, you should consult your doctor.
Overdose
If the recommended therapeutic dose of the Nurofen suspension is exceeded, abdominal pain, nausea, vomiting, tinnitus appear, metabolic acidosis may develop (a pH shift to the acidic side), impaired consciousness up to coma, blood pressure decreases, the rhythm and frequency of heart contractions is disturbed (arrhythmia). Treatment of overdose consists of gastric and intestinal lavage, taking intestinal sorbents (provided that no more than an hour has passed since taking the suspension), as well as symptomatic therapy.
Analogues of Nurofen for children
In terms of composition and therapeutic effect, the drugs Ibuprofen, Ibufen, and Advil are similar to the Nurofen suspension.
Terms and conditions of storage
The shelf life of Nurofen suspension is 3 years from the date of manufacture. The drug should be stored in a dry, dark place, out of reach of children, at an air temperature no higher than +25° C.
Nurofen children's price
The average cost of Nurofen suspension in Moscow pharmacies depends on its volume in the bottle:
- Bottles with a volume of 100 ml - rubles.
- Bottles with a volume of 150 ml - rubles.