Nurofen for children suspension 100mg/5ml orange, 200ml

Composition

In 5 ml of Nurofen® suspension for children contains: Active ingredient: ibuprofen 100 mg, excipients: Polysorbate 80 0.5 mg, glycerol,0.5 ml, syrup maltitol 1,625 ml, sodium saccharin 10 mg, citric acid 20 mg, sodium citrate 25,45 mg, xanthan gum 37.5 mg, sodium chloride 5.5 mg, domiphen bromide 0.5 mg, orange flavor,2 M 16014 or strawberry flavoring 500244 E 12.5 mg, purified water to 5 ml.

Pharmacological properties

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID).

ATX Code: M01AE01

Pharmacological properties

Pharmacodynamics :

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction. It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting prostaglandin synthesis. In addition, ibuprofen reversibly inhibits platelet aggregation. It has analgesic, antipyretic and anti-inflammatory effects. The analgesic effect is most pronounced in inflammatory pain. The effect of the drug lasts up to 8 hours.

Pharmacokinetics:

Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract (GIT) (connection with plasma proteins – 90%). After taking the drug on an empty stomach in adults, ibuprofen is detected in blood plasma after 15 minutes, the maximum concentration (Cmax) of ibuprofen in blood plasma is reached after 60 minutes. Taking the drug together with food can increase the time to reach the maximum concentration (TMAX) to 1-2 hours. The elimination half-life (T 1/2) is 2 hours. Slowly penetrates the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

Indications

Nurofen® suspension for children is used in children from 3 months of life to 12 years for symptomatic treatment as an antipyretic agent for acute respiratory diseases (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature.

The drug is used as a symptomatic analgesic for pain syndrome of mild or moderate intensity, including: toothache, headache, migraine, neuralgia, ear pain, sore throat, sprain pain, muscle pain, rheumatic pain, joint 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 that make up the drug.
• Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs.
• Bleeding or perforation of a history of gastrointestinal ulcers caused by the use of NSAIDs.
• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn’s disease, ulcerative colitis) active or history of ulcerative bleeding (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding).
• Severe liver failure or active liver disease.
• Severe renal insufficiency (creatinine clearance
• Decompensated heart failure, the period after coronary artery bypass grafting.
• Cerebrovascular or other bleeding.
• Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.
• Pregnancy (third trimester).
• Fructose intolerance.
• The child’s body weight is up to 5 kg.

Caution: If you have any of the conditions listed in this section, you should consult your doctor before using the drug. Concomitant use of other NSAIDs, a 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 – may develop bronchospasm; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic seizures. meningitis; chickenpox; renal failure, including dehydration (creatinine clearance 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); concomitant use of other medications that may increase the risk ulceration or bleeding, in particular, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), breastfeeding, advanced age.

Side effects

The risk of side effects can be minimized by taking the drug in a short course, at the minimum effective dose necessary to eliminate symptoms.

Side effects are mostly dose-dependent. The following adverse reactions were observed with short-term ibuprofen use in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.

The frequency of adverse reactions is estimated based on the following criteria: very frequent (≥ 1/10), frequent (≥ 1/100 to < 1/10), infrequent (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000), very rare (

Disorders of 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 ulcers in the mouth,

flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

Immune system disorders

· Infrequent: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnoea), skin reactions (pruritus, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Lyell’s syndrome, Stevens-Johnson syndrome, multiforme erythema), allergic rhinitis, eosinophilia.

· Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

Disorders of the gastrointestinal tract

* Infrequent: abdominal pain, nausea, dyspepsia.

* Rare: diarrhea, flatulence, constipation, vomiting.

· Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis.

* Frequency unknown: exacerbation of ulcerative colitis and Crohn’s disease.

Liver and biliary tract disorders

· Very rare: liver function disorders.

Kidney and urinary tract disorders

· Very rare: acute renal failure (compensated and decompensated), especially with prolonged use, in

combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis.

Nervous system disorders

* Infrequent: headache.

· Very rare: aseptic meningitis (in patients with autoimmune diseases).

Disorders of the cardiovascular system

* Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.

Respiratory and mediastinal disorders

* Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

Other services

· Very rare: edema, including peripheral edema.

Laboratory parameters

* hematocrit or hemoglobin (may decrease)

* bleeding time (may increase)

· plasma glucose concentration (may decrease)

* creatinine clearance (may decrease)

* plasma creatinine concentration (may increase)

* activity of “hepatic” transaminases (may increase)

If side effects occur, you should stop taking the drug and consult a doctor.

Interaction

Concomitant use of ibuprofen with the following medications should be avoided:

* Acetylsalicylic acid: except for low doses of acetylsalicylic acid (no more than 75

iu), as co-use may increase the risk of side effects. When used concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

* Other NSAIDs, including selective COX-2 inhibitors: concomitant use of two or more NSAID drugs should be avoided because of the possible increased risk of side effects.

Use with caution at the same time as the following medications::

* Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, particularly warfarin and thrombolytics.

* Antihypertensive agents (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.

* Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

* Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

* Cardiac glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma.

* Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma with the use of NSAIDs.

* Methotrexate: There is evidence of increased plasma concentrations of methotrexate associated with NSAID use.

* Cyclosporine: increased risk of nephrotoxicity with concomitant NSAIDs and cyclosporine.

* Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

* Tacrolimus: concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

* Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated with zidovudine and ibuprofen.

* Quinolone antibiotics: patients receiving concomitant treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.

How to take, course of use and dosage

Nurofen® for children is a suspension specially developed for children. For oral use. Patients with hypersensitivity of the stomach are recommended to take the drug with meals.

Only for short-term use. Please read the instructions carefully before taking the drug.

Shake the bottle thoroughly before use. 5 ml of the drug contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.

Using a measuring syringe:

Insert the measuring syringe firmly into the neck of the bottle. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark. Return the vial to its original position and remove the syringe by gently turning it. Place the syringe in your mouth and slowly depress the plunger, releasing the suspension smoothly.

After use, rinse the syringe in warm water and dry it out of the reach of the child.

Fever (fever) and pain:

Dosage for children depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg / kg of body weight of the child with intervals between doses of the drug 6-8 hours.

Children aged 3-6 months (child weight from 5 to 7.6 kg): 2.5 ml (50 mg) up to 3 times within 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): 5.0 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.

Duration of treatment-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.

Post-immunization fever:

Children under 6 months of age: 2.5 ml (50 mg) of the drug. If necessary, add 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 of body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life 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, there are manifestations of the central nervous system: drowsiness, rarely-agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis can develop. Patients with bronchial asthma may have an exacerbation of this disease.

Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic vital signs until the patient’s condition normalizes. Oral use of activated charcoal or gastric lavage within 1 hour of taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam. In case of worsening of bronchial asthma, the use of bronchodilators is recommended.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.

During long-term treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, it is not recommended to take ethanol. The drug is contraindicated in patients with fructose intolerance, as it contains maltitol.

Nurofen ® for children can be used in children with diabetes, as the drug does not contain sugar. It does not contain any colorants.

Patients with renal insufficiency should consult a doctor before using the drug, as there is a risk of deterioration of the functional state of the kidneys.

Patients with hypertension, including in the anamnesis and / or chronic heart failure, should consult a doctor before using the drug, since the drug can cause fluid retention, increased blood pressure and edema.

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid using the drug for chickenpox.

Impact on the ability to drive vehicles and other potentially dangerous mechanisms

Patients who experience dizziness, drowsiness, lethargy, or visual disturbances while taking ibuprofen should avoid driving vehicles or operating machinery.

Form of production

Suspension for oral use.

Storage conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Use within 6 months after opening the bottle.

Do not use an expired product.

Active ingredient

Ibuprofen

Dosage form

suspension for oral use

Purpose

Children over 6 months of age

Indications

Sore Throat, Migraine, Cold, Flu, Infectious diseases, Otitis media