Algidrin 120 ml oral suspension - influenza treatment in children

Product Description

Algidrin is indicated for children over 3 months of age and adolescents: for the symptomatic treatment of fever for the symptomatic treatment of mild to moderate pain.

Indications

Non-steroidal anti-inflammatory drug.
Propionic acid derivatives; ibuprofen.

Composition

Active ingredients

Each ml of oral suspension contains: 20 mg of ibuprofen (provided by 34.17 mg of ibuprofen lysine). Excipients with known effect: Sorbitol (E-420) 25 mg, maltitol (E-965) 100 mg, Allura red AC colour (E129) 0.0786 mg, methyl parahydroxybenzoate (E-218) 1.45 mg, ethyl parahydroxybenzoate (E-214) 0.32 mg, propyl parahydroxybenzoate (E-216) 0.22 mg.

Excipients

Purified water, Microcrystalline cellulose, Sodium carboxymethylcellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin, Sucralose (E-955), Wild berry flavour, Allura red AC colour (E-129), Methyl parahydroxybenzoate (E-218) 1.45 mg, Ethyl parahydroxybenzoate (E-214) 0.32 mg, Prop ... methyl (E-218), Ethyl parahydroxybenzoate (E-214), Propyl parahydroxybenzoate (E-216).

How to use and Dosage

Dosage: The lowest effective dose should be taken, as quickly as possible, to control symptoms.
Paediatric population: The dose of ibuprofen to be administered depends on the age and weight of the child.
For children aged 3 months to 12 years, the recommended daily dose of ibuprofen is 20 to 30 mg/kg of body weight, divided into three or four individual doses (see the table below). The use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg.
The interval between doses depends on the course of symptoms, but should never be less than 4 hours.
The following dosage schedule is recommended as a guideline.
Doses may be repeated every 6-8 hours, without exceeding the daily doses indicated in the last column:

Adolescents (over 12 years of age): The recommended dose is 10-20 ml (equivalent to 200-400 mg of ibuprofen) every 4-6 hours, if necessary, without exceeding the daily dose of 1200 mg of ibuprofen in 24 hours.
Given the amount of ibuprofen in this medicinal product, the use of other pack sizes with more suitable doses is recommended for the treatment of adults and adolescents over 12 years of age.
Renal impairment: Caution should be taken when using nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with renal impairment, since ibuprofen is generally eliminated by the kidneys.
Lower doses are used for patients with mild to moderate renal dysfunction.
Ibuprofen should not be used in patients with severe renal impairment.
Hepatic impairment: Although no differences in the pharmacokinetic profile of ibuprofen have been observed in patients with hepatic impairment, it is advisable to take precautions when using NSAIDs in these types of patients.
Patients with mild to moderate hepatic impairment should start treatment at lower doses and be carefully monitored. monitored.
Ibuprofen should not be used in patients with severe liver failure.
Method of administration: This medicine is administered orally.
It can be administered directly or diluted with water.
Shake the bottle before use.
The packs contain a 5 ml graduated syringe for oral use, for accurate dosing.
The syringe should be detached from the bottle, disassembled, washed and dried well after each use.
Patients with gastric problems should take the medicine during meals.

Warnings

Masking of symptoms of underlying infections: Algidrin may mask the symptoms of infection, which may lead to a delay in starting appropriate treatment and therefore worsen the outcome of the infection.
This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox.
When Algidrin is administered to relieve fever or pain related to infection, monitoring for infection is recommended.
In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Adverse reactions caused by the combination of the active ingredient and concomitant alcohol consumption, particularly reactions related to the gastrointestinal tract or the central nervous system, may be increased by the use of NSAIDs.
Gastrointestinal risks: Gastrointestinal bleeding, ulcers and perforations: Reports of gastrointestinal bleeding, ulcers and perforations (which can be fatal) have been received during treatment with NSAIDs, including ibuprofen, at any time, with or without preceding warning symptoms and with or without a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing doses of NSAIDs, in patients with a history of ulcers, especially if the ulcers are complicated by haemorrhage or perforation, and in elderly patients.
These patients should start treatment on the lowest possible dose and be prescribed concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors); Combination treatment should also be considered for patients requiring low-dose aspirin or other medications that may increase gastrointestinal risk factors.
Patients with a history of gastrointestinal toxicity, and particularly elderly patients, should be advised to seek immediate medical attention if infrequent abdominal symptoms (especially gastrointestinal bleeding) occur during treatment, especially in the initial stages.
Special caution is recommended for patients receiving concomitant medications that may increase the risk of gastrointestinal ulceration or bleeding, such as dicoumarin-based oral anticoagulants or antiplatelet agents such as acetylsalicylic acid.
Furthermore, certain precautions should be taken when administering oral corticosteroids concomitantly with selective serotonin reuptake inhibitor (SSRI) antidepressants.
Treatment should be discontinued immediately in the event of gastrointestinal bleeding or ulceration in patients receiving this medicine.
NSAIDs should be administered with caution to patients with a history of ulcerative colitis or Crohn's disease, as they may aggravate these conditions.
Cardiovascular and cerebrovascular risks: Particular caution should be exercised in patients with a history of hypertension and/or heart failure, as fluid retention and edema have been associated with NSAID treatment.
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg daily), may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g. 1,200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischemic heart disease, peripheral artery disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2,400 mg/day) should be avoided.
Careful consideration should also be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if they require high doses of ibuprofen (2,400 mg/day).
Risk of serious skin reactions: Very rare reports of serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs.
Patients appear to be at greatest risk of these reactions at the beginning of treatment: in most cases these adverse effects appear during the first month of treatment.
Acute generalized exanthematous pustulosis (AGEP) has been reported in relation to products containing ibuprofen.
Administration of the medicinal product should be discontinued immediately at the first symptoms of skin erythema, mucosal lesions or other signs of hypersensitivity.
On exceptional occasions, chickenpox may cause infectious complications of the skin and soft tissue. To date, the role of NSAIDs in exacerbating these infections cannot be excluded.
Therefore, ibuprofen should be avoided in case of chickenpox.
Allergic reactions: On very rare occasions, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
Treatment should be discontinued when the first signs of a hypersensitivity reaction appear after taking/administering ibuprofen.
Depending on the symptoms, the necessary medical measures should be initiated by specialist personnel.
Caution is required in patients who have suffered from hypersensitivity or allergic reactions to other substances, as this may increase the risk of hypersensitivity reactions to ibuprofen.
Caution is required in patients suffering from seasonal allergies, nasal polyps or chronic obstructive respiratory disorders, as there is a high risk of allergic reactions.
These reactions may present as asthma attacks, Quincke's edema or urticaria.
Renal and/or hepatic impairment: Ibuprofen should be used with caution in patients with liver or kidney disease, particularly during simultaneous treatment with diuretics, since prostaglandin inhibition may produce fluid retention and impair renal function.
If administered to these patients, the dose of ibuprofen should be kept as low as possible, and renal function should be monitored regularly.
There is a risk of renal impairment in children, adolescents, and elderly patients who are dehydrated.
In case of dehydration, ensure adequate fluid intake.
Special precautions should be taken in children with severe dehydration, for example due to diarrhea, as dehydration may act as a trigger for the development of renal failure.
In general, the habitual use of analgesics, especially the combination of several analgesic substances, can cause long-lasting renal damage, with a risk of renal failure (analgesic nephropathy).
Like other NSAIDs, long-term treatment with ibuprofen can cause renal papillary necrosis and other renal diseases.
Renal toxicity has also been observed in patients whose renal prostaglandins play a compensatory role in renal perfusion.
Elderly patients, patients with renal insufficiency, heart failure, hepatic dysfunction, and those treated with diuretics or antihypertensives (ACE inhibitors) are at high risk of experiencing this reaction. Discontinuation of NSAID therapy usually restores the pre-treatment state.
Like other NSAIDs, ibuprofen may produce mild, transient increases in some liver parameters and significant increases in AST and ALT levels.
Treatment should be discontinued in the event of a significant increase in these parameters.
Use in the elderly population: Elderly patients suffer from a higher incidence of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal. 
Others: As with other NSAIDs, anaphylactic/anaphylactoid reactions can occur without prior exposure to the drug.
It should also be used with caution in patients with a history of bronchial asthma, chronic rhinitis and allergic diseases, since cases of bronchospasm, urticaria and angioedema have been reported in these types of patients.
On rare occasions, cases of aseptic meningitis have been reported with the use of ibuprofen.
In the majority of cases, patients suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other connective tissue diseases), which represented a risk factor, although cases have also been reported in patients without chronic disease.
The observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever and disorientation.
Special medical supervision is required when administering to patients immediately after major surgery.
Like other NSAIDs, it should only be used after a rigorous risk/benefit assessment in patients with porphyria. acute intermittent.
Renal and hepatic function, haematological function and red blood cell count should be monitored as a precaution in patients on long-term treatment, since ibuprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time.
Undesirable effects can be minimised by using the lowest effective dose for as short a period as possible.
Warnings on excipients: This medicine may cause allergic reactions because it contains the red colouring Allura AC (E-129). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
This medicine contains maltitol (E-965) and each ml of suspension contains 25 mg of sorbitol (E-420).
Patients with hereditary fructose intolerance should not take this medicine.
This medicine contains methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214) and propyl parahydroxybenzoate (E-216) and may cause allergic reactions (possibly delayed).
Interference with analytical tests: Bleeding time (may be prolonged for 1 day after stopping treatment).
Blood sugar levels (may be reduced).
Creatinine clearance (may be reduced).
Haematocrit or haemoglobin levels (may be reduced).
Blood urea nitrogen concentrations and serum creatinine and potassium concentrations (may be increased).
Liver function tests: increased transaminase values.

Contraindications

Hypersensitivity to ibuprofen, to any other NSAID, or to any of the excipients.
Patients who have developed allergic reactions, asthma attacks, acute rhinitis, urticaria, or angioneurotic edema after taking substances with similar actions (e.g., acetylsalicylic acid or other anti-inflammatory drugs).
A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).
Peptic ulcer, active or recurrent gastrointestinal bleeding (two or more separate episodes of ulceration or hemorrhage).
Patients with diseases that tend to increase bleeding.
Severe heart failure (NYHA: class IV). - Severe renal insufficiency (glomerular filtration rate below 30 ml/min).
Severe hepatic insufficiency.
Patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
During the third trimester of pregnancy.

Interactions

In general, NSAIDs should be used with caution when used concomitantly with other drugs that may increase the risk of gastrointestinal ulceration, gastrointestinal bleeding, and renal dysfunction. Interactions have been reported with the following drugs:
Diuretics: may increase the nephrotoxicity of NSAIDs as a consequence of reduced renal blood flow. As with other NSAIDs, concomitant treatment with potassium-sparing diuretics may be associated with increased potassium levels, making it necessary to monitor plasma potassium levels.
Anticoagulants: NSAIDs may increase the effects of dicoumarin anticoagulants such as warfarin.
Antiplatelet agents: increase the risk of gastrointestinal bleeding.
NSAIDs should not be combined with ticlopidine, due to the risk of an additive effect in inhibiting platelet function.
Corticosteroids: may also increase the risk of gastrointestinal ulceration or bleeding.
Selective serotonin reuptake inhibitors (SSRIs): may also increase the risk of gastrointestinal bleeding.
Antihypertensive agents (including ACE inhibitors, beta-blockers and angiotensin II receptor antagonists): NSAIDs may reduce the effectiveness of antihypertensive agents, including ACE inhibitors or beta-blocking agents and angiotensin II receptor antagonists.
Simultaneous treatment with NSAIDs, ACE inhibitors, beta-blockers or angiotensin receptor blockers may be associated with risk of acute kidney disease, including acute renal failure, which is usually reversible.
Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be well hydrated and regular monitoring of renal function should be considered after initiation of concomitant treatment.
Acetylsalicylic acid and other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors: Simultaneous use should be avoided, as the administration of multiple NSAIDs may increase the risk of gastrointestinal ulceration and bleeding.
Acetylsalicylic acid: In general, concomitant administration of ibuprofen and acetylsalicylic acid is not recommended due to the potential for increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when administered concomitantly.
Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that long-term regular use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
It is likely that there is no clinically relevant effect with occasional use of ibuprofen.
Lithium: NSAIDs may increase plasma lithium levels, probably due to a decrease in its renal clearance.
Co-administration should be avoided unless lithium levels are monitored.
A reduction in the lithium dose should be considered.
Methotrexate administered at doses of 15 mg/week or greater: If NSAIDs and methotrexate are administered within a 24-hour interval, an increase in plasma methotrexate levels may occur (NSAIDs appear to reduce the tubular secretion and renal clearance of methotrexate), with an increased risk of methotrexate toxicity.
Therefore, the use of ibuprofen in patients receiving treatment with high doses of methotrexate should be avoided.
Methotrexate administered at low doses, below 15 mg/week: Ibuprofen increases methotrexate levels.
When used in combination with low-dose methotrexate, the patient's blood chemistry should be closely monitored, especially during the first weeks of simultaneous administration. Vigilance should also be increased in cases of even minimally impaired renal function and in elderly patients.
Renal function should be monitored to prevent any possible decrease in methotrexate clearance.
Sulfonylureas: NSAIDs may enhance the effect of sulfonylureas. Rare cases of hypoglycemia have been reported in patients treated with sulfonylureas and ibuprofen.
Mifepristone: Theoretically, the efficacy of this drug may be reduced due to the antiprostaglandin properties of NSAIDs.
Limited evidence suggests that concomitant administration of an NSAID on the same day as a prostaglandin does not negatively impact the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce clinical efficacy in inducing abortion. Cardiac glycosides (digoxin): NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate, and increase cardiac glycoside levels, thereby increasing the risk of digoxin toxicity.
Pentoxifylline: The risk of haemorrhage may be increased in patients receiving ibuprofen in combination with pentoxifylline. Therefore, monitoring of bleeding time is recommended. Probenecid and sulfinpyrazones: May cause increased plasma concentrations of ibuprofen; This interaction may be due to an inhibitory mechanism at the level of renal tubular secretion and glucuronidation, and the ibuprofen dose may need to be adjusted. Quinolones antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with the use of quinolone antibiotics.
Patients who have taken NSAIDs and quinolones may have a higher risk of experiencing convulsions. Hydantoins (phenytoin) and sulfonamides: The toxic effects of these substances may be increased. During simultaneous treatment with ibuprofen, plasma levels of phenytoin may increase. Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract, although the clinical relevance is unknown. Tacrine: Administering ibuprofen with tacrine increases tacrine toxicity, with episodes of delirium, due to possible inhibition of its binding to plasma proteins. Cyclosporine, tacrolimus: Simultaneous administration of NSAIDs may increase the risk of nephrotoxicity due to a reduction in renal prostaglandin synthesis.
If administered concomitantly, renal function should be closely monitored. Thrombolytics: The risk of bleeding may be increased.
Zidovudine: The risk of haematological toxicity may be increased when NSAIDs are administered with zidovudine.
There is an increased risk of joint bleeding and haematomas in HIV (+) patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen.
Aminoglycosides: NSAIDs may reduce the excretion of aminoglycosides.
Herbal extracts: Ginkgo biloba may increase the risk of haemorrhage with NSAIDs.
Alcohol: Concomitant use of alcohol may increase adverse effects related to the use of NSAIDs, especially those involving the gastrointestinal tract and the central nervous system.
Food: Administration of ibuprofen with food reduces the rate of absorption, although this has no effect on the extent of absorption.
CYP2C9 inhibitors: Administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (a CYP2C9 substrate).
A study with voriconazole and fluconazole (CYP2C9 inhibitors) showed an approximately 80% to 100% increase in exposure to S(+) ibuprofen. A lower dose of ibuprofen should be considered when co-administered with a potent CYP2C9 inhibitor, especially when ibuprofen is administered at high doses with voriconazole or fluconazole.