Ibuprofen baby

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IBUPROFEN BABY (IBUPROFEN BABY)

Composition:

Active ingredient: ibuprofen;

5 ml of the preparation contains 100 mg of ibuprofen;

Excipients: sorbitol (E 420); polysorbate 80; sodium hydrogen phosphate anhydrous; citric acid monohydrate; xanthan gum; glycerol; sodium saccharin; methylparaben (E 218); propylparaben (E 216); "Red orange" flavor containing ethanol 96%, triacetin, orange essential oil, natural orange extract, natural aromatic compounds (aldehydes and esters), butylhydroxyanisole (E 320); purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: white or almost white suspension with a characteristic odor.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and antirheumatic agents. Propionic acid derivatives.

ATC code M01AE01.

Pharmacological Properties

Pharmacodynamics

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which has demonstrated efficacy by inhibiting the synthesis of prostaglandins. In humans, ibuprofen reduces pain associated with inflammation, swelling, and fever. Ibuprofen exerts analgesic, antipyretic, and anti-inflammatory effects. The onset of analgesic and antipyretic action of ibuprofen has been shown to occur within 30 minutes. In addition, ibuprofen reversibly inhibits platelet aggregation.

Experimental data indicate that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation when both agents are administered concomitantly. In one study, a single 400 mg dose of ibuprofen taken within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg) resulted in reduced effect of acetylsalicylic acid on thromboxane formation or platelet aggregation. However, the limited nature of these data and uncertainty regarding extrapolation of ex vivo findings to the clinical setting preclude definitive conclusions about the systematic use of ibuprofen. Therefore, with occasional use of ibuprofen, such clinically significant effects are considered unlikely.

Pharmacokinetics

Ibuprofen is rapidly absorbed after administration and quickly distributed throughout the body. Elimination is rapid and complete, occurring via the kidneys.

Maximum plasma concentration is reached within 45 minutes after oral administration on an empty stomach. When administered with food, peak levels are observed within 1–2 hours. This time may vary depending on the pharmaceutical formulation.

The elimination half-life is approximately 2 hours. In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

Clinical characteristics.

Indications.

Symptomatic treatment of fever and pain of various origin in children aged 3 months to 12 years with body weight of at least 5 kg (including fever after vaccination, acute respiratory viral infections, influenza, teething pain, post-dental extraction pain, toothache, headache, sore throat, ligament sprain pain, and other types of pain, including those of inflammatory origin).

Contraindications.

• Hypersensitivity to ibuprofen or to any of the excipients of the medicinal product.
• History of hypersensitivity reactions (e.g., bronchospasm, bronchial asthma, rhinitis, angioedema, or urticaria) following the intake of acetylsalicylic acid (aspirin) or other NSAIDs.
• Active peptic ulcer/gastrointestinal bleeding or history of recurrent episodes (two or more confirmed episodes of peptic ulcer or bleeding).
• History of gastrointestinal bleeding or perforation associated with previous use of NSAIDs.
• Severe heart failure, severe hepatic insufficiency, or severe renal insuff游戏副本

Special precautions for use.

Adverse effects associated with ibuprofen can be minimized by using the lowest effective dose required to treat symptoms for the shortest possible duration.

Elderly individuals have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal. Elderly patients are at increased risk of serious adverse effects. Prolonged use of NSAIDs is not recommended in elderly patients. If long-term therapy is necessary, patients should be monitored regularly.

Caution is required in patients with the following conditions:

• Systemic lupus erythematosus and mixed connective tissue disease – due to an increased risk of aseptic meningitis;
• Congenital porphyrin metabolism disorders, such as acute intermittent porphyria;
• Gastrointestinal disorders and chronic inflammatory bowel diseases (e.g., ulcerative colitis, Crohn’s disease);
• History of arterial hypertension and/or heart failure, as there have been reports of fluid retention and edema associated with NSAID therapy;
• Renal impairment – due to the potential for worsening kidney function;
• Hepatic dysfunction;
• Immediately after major surgical procedures;
• Hay fever, nasal polyps, or chronic obstructive respiratory diseases due to an increased risk of allergic reactions (including asthma attacks (so-called analgesic-induced asthma), Quincke’s edema, or urticaria);
• Patients with a history of allergic reactions to other substances, due to an increased risk of hypersensitivity reactions to ibuprofen.

Respiratory effects.

Bronchospasm may occur in patients suffering from bronchial asthma or allergic diseases, or with a history of such conditions.

Other NSAIDs.

Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided, as this increases the risk of adverse reactions.

Systemic lupus erythematosus and mixed connective tissue disease.

Ibuprofen should be used with caution in patients with systemic lupus erythematosus and mixed connective tissue disease due to an increased risk of aseptic meningitis.

Cardiovascular and cerebrovascular effects.

Patients with a history of arterial hypertension and/or heart failure should begin treatment cautiously (medical consultation is required), as fluid retention, elevated blood pressure, and edema have been reported during ibuprofen therapy, as with other NSAIDs.

Clinical trial data and epidemiological evidence suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and for prolonged periods, may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Overall, epidemiological studies do not show that low doses of ibuprofen (e.g., ≤ 1200 mg per day) are associated with an increased risk of myocardial infarction.

Cases of Kounis syndrome have been reported in patients receiving ibuprofen therapy. Kounis syndrome manifests as cardiovascular symptoms due to coronary artery spasm caused by an allergic or hypersensitivity reaction, which may potentially lead to myocardial infarction.

Renal effects.

Generally, regular use of analgesics, especially combinations of different painkillers, may lead to chronic kidney damage with a risk of renal failure (analgesic nephropathy).

Caution is advised in patients with renal impairment due to the possibility of worsening kidney function.

There is a risk of renal failure in dehydrated children and adolescents.

Hepatic effects.

Hepatic function impairment.

Gastrointestinal effects.

NSAIDs should be used with caution in patients with a history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn’s disease), as their condition may worsen. Such patients should consult a physician.

Cases of gastrointestinal bleeding, perforation, and ulcers, which may be fatal, have been reported during NSAID therapy at any stage, regardless of prior warning symptoms or a history of severe gastrointestinal disorders.

The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, a history of peptic ulcer disease (especially complicated by bleeding or perforation), and in elderly patients. These patients should start treatment at the lowest dose. For such patients, as well as those requiring concomitant use of low-dose acetylsalicylic acid or other medications that may increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) is recommended.

Patients with a history of gastrointestinal toxicity, particularly elderly individuals, should be informed about any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.

Caution is required when treating patients who are concurrently using medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (e.g., acetylsalicylic acid).

If gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, treatment should be discontinued immediately.

Impairment of female fertility.

Limited data suggest that cyclooxygenase/prostaglandin synthesis inhibitors may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of therapy.

Severe cutaneous adverse reactions (SCARs).

Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis, which may be life-threatening or fatal, have been reported with ibuprofen use (see section "Adverse reactions"). Most such reactions occur within the first month of treatment.

If signs or symptoms suggestive of these reactions occur, ibuprofen should be discontinued immediately, and alternative treatment should be considered (if necessary).

In rare cases, chickenpox may lead to severe skin and soft tissue infections. The potential influence of NSAIDs in worsening such infections cannot currently be excluded; therefore, the use of ibuprofen in cases of chickenpox is not recommended.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If the first signs of a hypersensitivity reaction occur after taking ibuprofen, therapy should be discontinued immediately and medical attention should be sought.

Ibuprofen may temporarily inhibit platelet aggregation. Therefore, careful monitoring is recommended in patients with coagulation disorders.

During prolonged use of ibuprofen, liver function, kidney function, and hematological parameters/blood counts should be monitored regularly.

Prolonged use of any analgesic for headache treatment may worsen the condition. In such cases, medical consultation is required and treatment should be discontinued. Medication-overuse headache should be considered in patients with frequent or daily headaches despite (or because of) regular use of headache medications.

Concomitant use of alcohol and NSAIDs may enhance adverse reactions related to the active substance, particularly those affecting the gastrointestinal tract or central nervous system.

Masking symptoms of underlying infections.

NSAIDs may mask symptoms of infectious diseases and fever, potentially delaying appropriate treatment and thereby complicating the course of illness. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When NSAIDs are used for fever or pain relief during infection, monitoring for infection is recommended. In outpatient settings, patients should consult a physician if symptoms persist or worsen.

Excipients.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medication.

The presence of methylparaben (E 218) and propylparaben (E 216) in the formulation may cause allergic reactions (possibly delayed).

This medicinal product contains 1.446 mmol (or 33.252 mg) of sodium per 300 mg ibuprofen dose. Caution is advised in patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

The medication is intended for use in children under 12 years of age.

Pregnancy.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data indicate an increased risk of miscarriage, congenital heart defects, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is considered to increase with higher doses and longer duration of treatment. The absolute risk of cardiovascular malformations increases from less than 1% to approximately 1.5%.

From the 20th week of pregnancy, ibuprofen use may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after starting treatment and is usually reversible upon discontinuation. Additionally, there have been reports of arterial duct constriction after treatment in the second trimester, most of which resolved after stopping treatment. Therefore, ibuprofen should not be used during the first two trimesters of pregnancy unless the expected benefit to the patient outweighs the potential risk to the fetus. If ibuprofen is used by a woman trying to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible duration. Fetal monitoring for oligohydramnios and arterial duct constriction should be considered after several days of ibuprofen exposure starting from the 20th gestational week. Treatment should be discontinued if oligohydramnios or arterial duct constriction is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose the following risks:

To the fetus: cardiopulmonary toxicity (characterized by premature constriction/closure of the arterial duct and pulmonary hypertension); renal dysfunction, which may progress to renal failure accompanied by oligohydramnios (see above);

To the mother and newborn (towards the end of pregnancy): prolonged bleeding time, antiplatelet effect (which may occur even at very low doses); inhibition of uterine contractions, leading to delayed or prolonged labor. Increased risk of maternal edema is possible. Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding.

Ibuprofen and its metabolites are excreted in breast milk in low concentrations. No adverse effects on the infant have been reported to date; therefore, interruption of breastfeeding is usually not required during short-term treatment of pain and fever at recommended doses.

Fertility.

There is some evidence that drugs inhibiting cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment. Therefore, the use of ibuprofen is not recommended in women experiencing difficulty conceiving.

Ability to affect reaction speed when driving or operating machinery. The medication is intended for use in children under 12 years of age. When used according to recommended doses and for the appropriate duration, no effect on the ability to drive or operate machinery is expected.

Dosage and administration.

Adverse effects can be minimized by using the lowest effective dose necessary to control symptoms for the shortest duration of time.

For oral use. The recommended daily dose of the medicinal product is 20–30 mg/kg body weight, divided into equal doses according to age and body weight, administered at intervals of 6–8 hours. To ensure accurate dosing, the package contains a dosing device. The recommended dose should not be exceeded. For short-term use only.

Do not use the medicinal product in children under 3 months of age unless recommended by a physician; also do not use it in children with body weight less than 5 kg.

For children aged 3 to 6 months: if symptoms persist for longer than 24 hours from the start of treatment or worsen (after 3 doses), seek immediate medical advice.

If in children aged 6 months to 12 years symptoms persist for more than 3 days from the start of treatment or worsen, medical advice should be sought.

For fever after vaccination (children aged 3–6 months), the recommended daily dose is 2.5 ml of suspension (50 mg); if necessary, an additional 2.5 ml of suspension (50 mg) may be given after 6 hours, but not more than 5 ml of suspension (100 mg) within 24 hours. If symptoms persist, medical advice must be sought.

For patients with sensitive stomach, the medicine should be taken during meals.

Shake well before use.

Special patient categories:

Renal impairment: dose reduction is not required in patients with mild to moderate renal dysfunction (for patients with severe renal impairment, see section "Contraindications").

Hepatic impairment: dose reduction is not required in patients with mild to moderate hepatic dysfunction (for patients with severe hepatic impairment, see section "Contraindications").

In case of overdose, seek immediate medical advice.

Children. The medicine should be used in children aged 3 months to 12 years with body weight of at least 5 kg.

Overdose.

In pediatric patients, symptoms of overdose may occur after ingestion of an ibuprofen dose exceeding 400 mg/kg. In adults, reactions to overdose are generally less pronounced. The elimination half-life in overdose is 1.5–3 hours.

Symptoms. In most patients, ingestion of a clinically significant amount of NSAIDs causes only nausea, vomiting, epigastric pain, and less frequently diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. In more severe poisoning, toxic effects on the central nervous system may develop, such as vertigo, dizziness, drowsiness, sometimes excitement, disorientation, or coma. Seizures may occasionally develop in patients. Severe poisoning may lead to hyperkalemia and metabolic acidosis, as well as prolonged prothrombin time/INR (likely due to interaction with circulating blood coagulation factors). Acute renal failure, liver damage, hypotension, respiratory depression, and cyanosis may occur. In patients with bronchial asthma, asthma exacerbation is possible. Nystagmus, visual blurring, and loss of consciousness may also occur.

Treatment. There is no specific antidote. Treatment should be symptomatic and supportive, including maintenance of airway patency and monitoring of cardiac function and vital signs until the patient's condition normalizes. Consideration should be given to administering oral activated charcoal or gastric lavage if less than 1 hour has passed since ingestion of a potentially toxic dose. If ibuprofen has already been absorbed, alkalizing agents may be used to enhance urinary excretion of the acidic ibuprofen. In cases of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered. In case of bronchial asthma exacerbation, bronchodilators should be administered. Seek immediate medical assistance.

Side effects.

The following list of side effects includes all adverse reactions reported during treatment with ibuprofen, including those observed with high doses and long-term therapy in patients with rheumatism. The frequencies stated beyond very rare reports refer to short-term use of doses (maximum 1200 mg ibuprofen per day) for oral dosage forms.

It should be noted that the side effects mentioned are predominantly dose-dependent and may vary individually for each patient.

Adverse reactions reported during the use of ibuprofen are listed below by organ systems and frequency of occurrence. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), and frequency not known (cannot be estimated based on available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

The most commonly observed adverse reactions were gastrointestinal. Adverse reactions are mostly dose-dependent; in particular, the risk of gastrointestinal bleeding depends on dose and duration of treatment. Gastrointestinal ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. Nausea, vomiting, diarrhea, abdominal distension, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after ibuprofen use; gastritis is less common.

Edema, arterial hypertension, and heart failure have been reported in association with NSAID therapy.

Clinical trial data and epidemiological evidence suggest that the use of ibuprofen, particularly at high doses (up to 2400 mg per day) and during prolonged treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke).

Cases of worsening inflammation associated with infection, such as the development of necrotizing fasciitis, have been reported temporally related to NSAID use. This may be related to the mechanism of action of NSAIDs.

If signs of infection appear or worsen during ibuprofen treatment, patients should seek immediate medical advice. The need for antimicrobial/antibiotic therapy should be evaluated.

Regular blood tests are recommended during long-term therapy.

Patients should seek immediate medical attention and discontinue ibuprofen if any symptoms of hypersensitivity reactions occur, which may develop even after the first dose. Immediate medical assistance is required in such cases.

If severe epigastric pain, melena, or hematemesis occurs, the drug should be discontinued and immediate medical attention sought.

Infections and infestations.

Very rare: worsening of infection-related inflammation (e.g., development of necrotizing fasciitis; in exceptional cases, chickenpox may lead to severe skin and soft tissue infections).

Blood and lymphatic system disorders.

Very rare: blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include fever, sore throat, oral mucosal ulcers, flu-like symptoms, severe exhaustion, epistaxis, skin bleeding, and bruising.

Immune system disorders.

Hypersensitivity reactions¹; uncommon: urticaria and pruritus.

Very rare: severe hypersensitivity reactions, symptoms of which may include facial, tongue, and laryngeal swelling, dyspnea, tachycardia, hypotension (anaphylactic reaction, angioneurotic edema, or severe shock); asthma exacerbation.

Nervous system disorders.

Uncommon: headache, dizziness, insomnia, restlessness, irritability, or fatigue.

Very rare: aseptic meningitis².

Cardiac disorders.

Very rare: heart failure, tachycardia, edema, myocardial infarction.

Frequency not known: Kounis syndrome.

Vascular disorders.

Very rare: arterial hypertension, vasculitis.

Gastrointestinal disorders.

Common: abdominal pain, nausea, dyspepsia, diarrhea, meteorism, constipation, heartburn, vomiting, and minor gastrointestinal blood loss, which in exceptional cases may lead to anemia.

Uncommon: gastric and duodenal ulceration, perforation, or gastrointestinal bleeding, melena, hematemesis, sometimes fatal (particularly in elderly patients), ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn's disease.

Very rare: esophagitis, formation of diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders.

Very rare: liver function abnormalities, liver damage, particularly during long-term therapy, liver failure, acute hepatitis.

Skin and subcutaneous tissue disorders.

Uncommon: various skin rashes¹.

Very rare: severe skin reactions (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)¹, alopecia.

Frequency not known: drug-induced eosinophilia with systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis¹, photosensitivity reactions.

Respiratory, thoracic and mediastinal disorders.

Frequency not known: respiratory tract reactivity, including asthma, bronchospasm, or dyspnea¹.

Renal and urinary disorders.

Rare: acute renal function impairment, particularly with prolonged use of NSAIDs, associated with increased serum urea levels; papillary necrosis.

Very rare: edema formation, especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure.

Investigations.

Rare: decreased hemoglobin levels.

Psychiatric disorders.

Very rare: psychotic reactions, depression; with prolonged use: hallucinations, confusion.

Eye disorders.

Frequency not known: visual disturbances, optic neuritis may occur with prolonged treatment.

Ear and labyrinth disorders.

Frequency not known: dizziness may occur with prolonged treatment.

Rare: tinnitus.

General disorders.

Frequency not known: malaise and fatigue.

Description of selected adverse reactions

¹ Reports exist of hypersensitivity reactions following treatment with ibuprofen. These include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactions, including bronchial asthma, asthma exacerbation, bronchospasm, or dyspnea, or (c) various skin disorders, including rashes of different types, pruritus, urticaria, purpura, angioedema; less frequently, exfoliative and bullous dermatoses (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalized exanthematous pustulosis).

² The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAID use suggest a hypersensitivity reaction (based on temporal relationship to drug intake and resolution of symptoms after discontinuation). In particular, isolated cases of aseptic meningitis symptoms (such as nuchal rigidity, headache, nausea, vomiting, fever, or disorientation) have been observed during ibuprofen treatment in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 100 ml or 200 ml in a bottle with a dosing device in a carton.

Pharmaceutical category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and location of business activity.

22 Shevchenka Street, Kharkiv, Kharkiv Region, 61013, Ukraine.