Ibuprofen oral suspension for children 100mg/5ml Strawberry, 100g

Composition

Active ingredient:

ibuprofen– 100,00 mg

Auxiliary substances:

syrup maltitol – 2111,25 mg; Glycerol – 600,00 mg;

gum xanthan – 37,50 mg; sodium citrate – 25,45 mg; citric acid – 20,00 mg; flavouring (orange/strawberry) – 12,50 mg; sodium saccharin – 10.00 mg; sodium chloride – 5,50 mg; domiphen bromide – 0,50 mg; Polysorbate 80 – 0,50 mg; purified water to 5.0 ml of

Pharmacological properties

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID)

ATX code: M 01 AE 01

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 (With_max) of ibuprofen in blood plasma is reached after 60 minutes. Taking the drug with food can increase the time to reach the maximum concentration (TC_max) 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

Ibuprofen 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.

Use during pregnancy and lactation

The use of the drug in the third trimester of pregnancy is contraindicated. Before using the drug in the first-second trimesters of pregnancy or during breastfeeding, you should consult your doctor. There is evidence that ibuprofen in small amounts can enter breast milk without any negative consequences for the health of the infant.

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.

With caution

If you have any of the conditions listed in this section, you should consult your doctor before using the drug.

The simultaneous intake of other NSAIDs, a history of a single episode of peptic ulcer or bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, infection with Helicobacter pylori, ulcerative colitis, bronchial asthma or allergic disease in the acute stage or in history – perhaps the development of bronchospasm, severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (sharp’s syndrome) – increased risk of aseptic meningitis; chickenpox; renal insufficiency, including dehydration (creatinine clearance 30-60 ml/min), fluid retention and edema, hepatic failure, hypertension and/or heart failure, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, blood disease of unknown etiology (leukopenia, anemia); simultaneous reception of other drugs that may increase the risk of ulceration or bleeding, in particular, oral corticosteroids (including prednisone), anticoagulants (including warfarin), selective inhibitors of serotonin reuptake (including citalopram, fluoxetine, paroxetine, and sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), lactation, old 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 (

Blood and lymphatic system disorders

are 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.

Violations of the immune system

-Infrequent: hypersensitivity reactions are non – specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Lyell’s syndrome, and Stevens-Johnson syndrome, erythema multiforme), 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).

Gastrointestinal disorders

-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 are very rare: liver function disorders.

Renal and urinary tract

disorders are 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

-The frequency is 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.

Others

are very rare: edema, including peripheral edema.

Laboratory parameters

-hematocrit or hemoglobin (may decrease)

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.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

100 ml in a dark glass bottle, sealed with a polymer lid or a polymer lid with autopsy control and protection against opening by children. Under the lid is a plastic adapter for the syringe. The measuring spoon package does not include an adapter.

200 ml in a dark glass bottle, sealed with a polymer lid or a polymer lid with autopsy control and protection against opening by children. Complete set with measuring spoon.

A self-adhesive label is applied to the bottle.

1 bottle with instructions for use is placed in a pack of cardboard

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Ibuprofen

Dosage form

Oral suspension