Pediatric Ibudol 200mg 20 Sachets Oral Suspension

Pediatric Ibudol (200 Mg 20 Envelopes Oral Suspension 10 Ml)

ibuprofen

ACTION AND MECHANISM

- Analgesic, anti-inflammatory, antipyretic. Ibuprofen is a derivative of propionic acid, with anti-inflammatory, analgesic and antipyretic activity. Its mechanisms of action could be due to the inhibition of the peripheral synthesis of prostaglandins due to its competitive and reversible binding to the enzyme cyclooxygenase, an enzyme that transforms arachidonic acid into said prostaglandins.

PHARMACOKINETICS

Ibuprofen acid is a racemic compound, of which the S(+)-enantiomer possesses almost all of the pharmacological activity. In vivo, almost 70% of the R(-)-enantiomer of acidic ibuprofen is converted to the S(+)-enantiomer, pharmacologically active.

Linear pharmacokinetics in the dosage range of 200-800 mg

- Absorption:

* Oral administration: good and rapid oral absorption, with a bioavailability of 80% and a tmax of 1-3 h, depending on the pharmaceutical form (47 min in suspension, 120 min in tablets). The arginine and lysine salts favor the solubilization of ibuprofen, so it is absorbed even more rapidly, with a tmax of 20-30 min. After administration of a 200 mg dose, the cmax is 15-20 mcg/ml.

Antipyretic effects begin within an hour, are maximal at 2-4 hours, and can last for periods of 6-8 hours.

On the other hand, to achieve anti-inflammatory effects, up to 2 weeks of treatment may be required.

Effect of food : they delay absorption by around 30-60 min and cmax by 30-50%, although they do not affect the total amount absorbed.

- Distribution: high binding to plasma proteins (90-99%). Vd of 0.1-0.2 l/kg. Ibuprofen diffuses well, passes into synovial fluid and crosses the placental barrier. It has not been detected in the milk of lactating women (detection limit 0.5 mcg/ml).

- Metabolism: extensively metabolized in the liver by hydroxylation and carboxylation of the isobutyl group, generating several inactive metabolites, of which the main ones are 2-[4-(2-hydroxy-2-methyl-propyl)-phenyl]propionic acid and 2-[4-(carboxypropyl)-phenyl]propionic acid

- Elimination: in urine (90%; 50-60% major metabolites and their glucuronides and <10% unchanged), with minor amounts in faeces. The t1/2 is 2-4 hours, and its elimination is complete at 24 hours.

Pharmacokinetics in special situations :

- Children: although the distribution and t1/2 appear similar to those of adults, the CLt of ibuprofen could be affected by age.

- Renal insufficiency: in mild insufficiency (CLcr 60-90 ml/min) there is an increase in the free fraction (3%), an increase in the AUC and the ratio of the S/R enantiomers. The elimination of metabolites could be reduced in patients with more severe renal insufficiency.

- Hepatic insufficiency: in moderate insufficiency (Child-Pugh class B), t1/2 was doubled while the ratio of S/R enantiomers was reduced, which would indicate the difficulty of converting the R enantiomer into the active form.

INDICATIONS

- Treatment of mild to moderate [PAIN].

- Symptomatic treatment of [FEVER].

POSOLOGY

- Children (7 years -> 12 years):
The dose depends on the age and weight of the child. Recommended daily dose: in general it is 20 - 30 mg/kg of weight, distributed between three or four individual doses.
* Children of 25 - 40 kg (7 - 12 years approx.): 200 mg/6-8 h. Maximum dose 800 mg/24 h.
* Children > 40 kg (> 12 years): 200 mg/6 h or 400 mg/8 h. Maximum dose 1,200 mg/24 h.
- Children < 25 Kg (< 7 years approx.): The use of this medication is not recommended since the dose (200 mg of ibuprofen) does not adapt to the recommended dosage in these patients.
- Adolescents and adults: the use of other presentations with more adequate doses is recommended.
The interval between doses will depend on the evolution of the symptoms, but it will never be less than 4 hours.
Administration with food : Administer with food.
Duration of treatment : consult your doctor and/or pharmacist in case of worsening of symptoms or persistence for more than 5 days (pain) or 3 days (fever).
Missed dose : Administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN RENAL INSUFFICIENCY

- Mild to moderate renal insufficiency (CLcr 30-90 ml/min): use with caution at the lowest possible dose.

- Severe renal insufficiency (CLcr < 30 ml/min): contraindicated.

DOSAGE IN HEPATIC INSUFFICIENCY

- Mild to moderate hepatic insufficiency (Child-Pugh classes A and B): use with caution at the lowest possible dose.

- Severe liver failure (Child-Pugh class C): contraindicated.

RULES FOR CORRECT ADMINISTRATION

Administration with food : Administer with food.

- Oral suspension sachets: press the sachet with your fingers to homogenize its content, and then drink directly or dilute the suspension in water.

CONTRAINDICATIONS

- Hypersensitivity to ibuprofen or any component of the drug. Cases of cross-hypersensitivity reactions with other NSAIDs have been described, so it should not be used in the case of [ALLERGY TO SALICYLATES] or [ALLERGY TO NSAIDs]. These allergic reactions are especially common in patients with asthma, nasal polyps, or who have experienced rhinitis, angioedema, or urticaria while receiving another NSAID or salicylates.

- [PEPTIC ULCER] active or recurrent, active inflammatory bowel disease or any other process that increases the risk of [GASTROINTESTINAL HEMORRHAGE]. Ibuprofen has ulcerogenic effects due to the inhibition of prostaglandin synthesis, which could increase the risk of gastrointestinal bleeding and perforation.

- [COAGULATION ALTERATIONS]. Ibuprofen has antiplatelet effects, although less powerful and long-lasting than those of acetylsalicylic acid. Therefore, it can increase the bleeding time, so it should be used with caution in patients with [HEMORRHAGIC DIATHESIS] or active [HEMORRHAGE], as well as in patients with [THROMBOCYTOPENIA].

- Perioperative pain in the setting of a coronary bypass.

- Severe renal insufficiency (CLcr < 30 ml/min). Safety and efficacy have not been evaluated, so it is advised not to use.

- Severe liver failure (Child-Pugh class C). Safety and efficacy have not been evaluated, so it is advised not to use.

- Severe heart failure (NYHA class III-IV) or uncontrolled high blood pressure. Fluid retention could worsen these pathologies.

- Pregnancy. Its use is contraindicated during the third trimester of pregnancy, and its use is not recommended for prolonged periods of time in the first two trimesters.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Ibuprofen is eliminated in the urine, so in case of kidney failure accumulation could occur, with the risk of intoxication. In addition, it could lead to a decrease in renal blood flow with reversible acute renal failure due to the inhibition of vasodilator prostaglandin synthesis, and cases of nephrotic syndrome and acute interstitial nephritis have even been described with prolonged treatment. In patients with mild to moderate insufficiency (CLcr between 30-90 ml/min), it is recommended to start treatment with a lower dose than in patients with normal renal function, carefully monitoring the patient. Use in severe insufficiency (CLcr < 30 ml/min) is contraindicated (See Contraindications).

- [LIVER FAILURE]. Due to its hepatic metabolism, accumulation and intoxication could occur in case of hepatic insufficiency. In patients with mild to moderate insufficiency (Child-Pugh class A or B), it is recommended to start treatment with a lower dose than in patients with normal liver function, carefully monitoring the patient. The use in severe insufficiency (Child-Pugh class C) is contraindicated (See Contraindications).

- History of peptic ulcer. The use of an NSAID, including ibuprofen, has given rise to cases of gastroduodenal ulcers, as well as hemorrhage and cases of perforation that could be fatal. The risk of ulcer is increased in treatments at high doses or for long periods of time, patients with a history of peptic ulcer, especially if they have already had gastrointestinal bleeding or perforation, as well as in the elderly.

As a general rule, it is advisable to administer any NSAID with food, to reduce gastric damage. In addition, in risk groups, it is advisable to start treatment with the lowest possible dose, and always associate an antiulcer drug (h3 antihistamines or pump inhibitors) whenever possible.

These patients should be closely monitored, as well as those receiving drugs that may promote bleeding, such as oral anticoagulants or platelet antiaggregants.

If symptoms of active ulcer or gastrointestinal bleeding appear, treatment will be discontinued. Similarly, ibuprofen should not be started in people with active peptic ulcer disease (see Contraindications).

- [INFLAMMATORY BOWEL DISEASE]. NSAIDs could precipitate symptomatic crises of diseases such as Crohn's disease or ulcerative colitis, so it is advisable to use them with caution, and avoid their use in active diseases (See Contraindications).

- Cardiovascular effects. NSAIDs could lead to fluid retention (especially with prolonged use), due to the inhibition of the synthesis of vasodilator prostaglandins, which could lead to the appearance or aggravation of [ARTERIAL HYPERTENSION], especially in cases in which that there is no previous treatment, or in which it has not been able to control the disease.

On the other hand, the administration of high doses of ibuprofen (=/> 2400 mg/24 h) has been associated with an increased risk of arterial thrombosis, similar to that of specific COX-2 inhibitors at therapeutic doses. Therefore, it is recommended to avoid the use of these doses in patients with moderate to severe [HEART FAILURE] (NYHA classes II-IV), [ISCHEMIC HEART DISEASE], [PERIPHERAL ARTERY DISEASE], [STROKE] or [CEREBRAL ISCHEMIA].

Before starting long-term treatment with ibuprofen, and especially if high doses are needed, it would be advisable to evaluate other cardiovascular risk factors such as [DYSLIPEMIA], [DIABETES] or [SMOKING].

The use of reduced doses of ibuprofen (1,200 mg/24 h) and for a limited period of time does not seem to present the same cardiovascular risks. Therefore, as with other NSAIDs, the general recommendation would be to use it at the lowest dose that allows symptoms to be controlled and for the shortest period of time possible.

- Skin reactions. The use of NSAIDs has caused very rare but potentially fatal serious adverse reactions such as exfoliative dermatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome. These adverse reactions are usually early onset, within the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or skin erythema are observed, treatment will be discontinued.

- Chronic [ASTHMA]. In these patients, the appearance of hypersensitivity reactions with bronchospasm is especially frequent, so extreme precautions are recommended. If worsening of respiratory function is observed, treatment will be discontinued.

- [ASEPTIC MENINGITIS]. Rare cases of aseptic meningitis have been reported in patients treated with NSAIDs, probably due to a hypersensitivity reaction, although no cross-allergy between NSAIDs has been found. It has been more frequent in patients with [SYSTEMIC LUPUS ERYTHEMATOSUS] and other [COLAGENOSIS], although it has also been reported in some patients who did not suffer from these pathologies. In patients treated with NSAIDs who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered.

- Ibuprofen lysine is contraindicated in case of infection or suspected infection in preterm infants.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains sodium salts. To know the exact sodium content, it is recommended to review the composition. Oral and parenteral pharmaceutical forms with amounts of sodium greater than 1 mmol (23 mg)/maximum daily dose should be used with caution in patients with [ARTERIAL HYPERTENSION], [KIDNEY INSUFFICIENCY] or with low-sodium diets.

- This medicine contains maltitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVICE TO THE PATIENT

- The patient should inform their doctor if they experience skin rashes, symptoms that could be related to a gastroduodenal ulcer (such as epigastric pain or dark stools), visual disturbances, weight gain, edema or prolonged headache.

- The patient should notify the doctor if they have had an asthmatic reaction while taking this medicine.

SPECIAL WARNINGS

- Gastrointestinal risk: NSAIDs are associated with an increased risk of gastrointestinal irritation, ulceration, bleeding or gastrointestinal perforation. Lesions can appear at any time during treatment. The elderly are at increased risk of serious gastrointestinal events. During prolonged treatment, possible signs and symptoms of ulceration or bleeding should be monitored. A history of oesophagitis, gastritis and/or peptic ulcer disease should also be sought to ensure complete cure before starting treatment with an NSAID.

- Cardiovascular risk: NSAIDs are associated with an increased risk of cardiovascular events, including myocardial infarction and new cases of hypertension or worsening of existing ones. The risk may increase with the duration of treatment, especially in patients with cardiovascular disease or with risk factors for cardiovascular disease. Monitor possible signs of hydrosaline retention (eg, edema formation), especially in patients with hypertension or heart failure.

- Risk of serious skin reactions: severe cases, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported on rare occasions in association with the use of NSAIDs. Patients may be at increased risk of these reactions early in treatment: the onset of such an adverse reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) associated with ibuprofen-containing products has been reported. Ibuprofen administration should be discontinued at the first signs or symptoms of serious skin reactions, such as rash, mucosal lesions, or any other sign of hypersensitivity.

INTERACTIONS

"INTERACTIONS RELATED TO IBUPROFEN"

- NSAIDs, including low doses of acetylsalicylic acid: the simultaneous use of more than one NSAID should be avoided due to the risk of adverse effects appearing without increasing therapeutic efficacy. In addition, ibuprofen could reduce the antiplatelet efficacy of aspirin when co-administered. If the administration of both drugs is needed, it is advisable to space the intakes (administer ibuprofen 8 hours before or 30 minutes after ASA).

- Alcohol: toxicity can be enhanced.

- Aliskiren: possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with compromised renal function (dehydrated or elderly) deterioration of renal function may be precipitated (possible acute renal failure, usually reversible). Caution, especially in the elderly, monitoring the antihypertensive effect and renal function.

- Food: food delays Tmax (from ± 2 h fasting to ± 3 h after eating), although this has no effect on the amount absorbed.

- Quinolone antibacterials: there are isolated reports of seizures that may have been due to the concomitant use of quinolones and some non-steroidal anti-inflammatory drugs.

- Oral anticoagulants, heparin: possible increase in anticoagulant effect, with risk of bleeding. Periodic controls of coagulation indices are recommended.

- Antidiabetic sulfonylureas (chlorpropamide, glibenclamide, tolbutamide): possible increase in hypoglycemic effects, by reducing renal excretion.

- SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram): possible increased risk of bleeding in general, and gastrointestinal bleeding in particular, especially in the elderly and patients with a history of gastrointestinal bleeding.

- Antihypertensives (ACE inhibitors, Beta-blockers): possible reduction of the antihypertensive effect.

- Oral bisphosphonates (alendronic acid): possible increased risk of esophagitis and gastric ulcer. Cases described with naproxen and alendronate.

- Cyclosporine: the effect of NSAIDs on renal prostaglandins can increase the nephrotoxicity of cyclosporine.

- Platelet antiaggregants, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal bleeding in particular. Administer with caution.

- Corticosteroids: possible increase in the incidence of gastric discomfort. However, concurrent use with glucocorticoids in the treatment of osteoarthritis may provide additional therapeutic benefit and allow the glucocorticoid dosage to be reduced.

- Digitalis (digoxin): possible increase in plasma concentrations of digitalis (in neonates). There is also a risk of worsening heart failure and reduced kidney function.

- Diuretics (thiazides, high ceiling diuretics): risk of reduction of the natriuretic and diuretic effect. May reduce antihypertensive action of thiazide diuretics.

- Potassium-sparing diuretics and aldosterone antagonists: possible increased risk of hyperkalaemia. Frequent monitoring of serum potassium levels is advised.

- Glitazones (pioglitazone, rosiglitazone): theoretical risk of increased edema that both glitazones and NSAIDs can cause. Caution and monitor for signs of fluid retention and heart failure (swollen ankles, dyspnea).

- Hydralazine: possible decrease in hypotensive effect.

- Iloprost: possible increased risk of bleeding.

- Lithium, salts: possible increased toxicity of lithium due to a reduction in its elimination.

- Methotrexate (administered at doses of 15 mg/week or higher): possible increase in plasma levels of methotrexate, with the risk of toxicity, sometimes very serious. The severity depends largely on the doses of methotrexate used. The risk of interaction is reduced with low doses of methotrexate such as those used in psoriasis and rheumatoid arthritis.

- Mifepristone: Non-steroidal anti-inflammatory drugs should not be administered within 8-12 days of mifepristone administration as these may reduce its effects.

- Paracetamol: the simultaneous and prolonged use of paracetamol and NSAIDs may cause an increased risk of adverse renal effects.

- Pentoxifylline: In patients receiving treatment with ibuprofen in combination with pentoxifylline, the risk of bleeding may increase, so it is recommended to monitor the bleeding time.

- Potassium supplements: possible increase in potassium levels, with risk of hyperkalaemia.

- Ticlopidine: possible increased risk of bleeding.

- Zidovudine: Possible alteration of the reticulocytes, with severe anemia appearing one week after the start of the NSAID administration. Hematic values ​​should be monitored, especially at the beginning of treatment.

PREGNANCY

Safety in animals: no teratogenic effects have been recorded, but fetal damage has been reported on important occasions, as well as affectation of parturition.

Safety in humans: There are no adequate and well-controlled studies in humans. Inhibition of fetal prostaglandin synthesis during the first two gestational trimesters has been associated with an increased risk of miscarriage, cardiac malformations (up to 1.5% more than with placebo) and gastroschisis. The risk appears to increase with high doses and prolonged treatment.

On the other hand, chronic use during the third trimester could theoretically produce premature closure of the fetal ductus arteriosus and fetal renal dysfunction with risk of oligohydroamniosis. In addition, due to its platelet antiaggregating effects, the bleeding time could be prolonged, with possible fetal affectation and risks in childbirth. Another possible effect that could appear is the reduction and even cancellation of uterine contractility, causing an abnormal delay in childbirth and a non-physiological prolongation of pregnancy.

It is unknown whether timely administration of an NSAID could pose a fetal risk.

The use of ibuprofen during the first two trimesters of pregnancy is only accepted in the event that, in the absence of safer therapeutic alternatives, the benefits outweigh the possible risks. If it has to be used, it will be done at the lowest possible dose and for the shortest possible time. The use of an NSAID in the third trimester is contraindicated.

Effects on fertility: Ibuprofen can impair female fertility and is not recommended in women trying to conceive. In women with difficulties conceiving or who are undergoing fertility investigation, discontinuation of this drug should be considered.

LACTATION

Following ingestion of 400 mg ibuprofen, no detectable concentrations have been detected in breast milk, with a detection limit of 0.5-1 mcg/mL. However, the manufacturers advise against use during lactation, due to the risk of inhibiting cyclooxygenase in the infant.

CHILDREN

Safety and efficacy in children under 3 months have not been established, so its use is not recommended. Ibuprofen should not be self-medicated in children under 12 years of age.

ELDERLY

The elderly seem to be more susceptible to the adverse effects of NSAIDs. The risk of severe ulcer disease is increased in those over 65 years of age, and appears to be dose-dependent. They can also cause fluid retention, which can lead to cardiovascular complications and reduce the effectiveness of antihypertensive treatments. It is recommended to use with caution, using the lowest possible effective dose.

EFFECTS ON DRIVING

Patients who experience dizziness, vertigo, visual disturbances, or other central nervous system disorders while taking ibuprofen should refrain from driving or operating machinery. Generally short treatments do not require special precautions.

ADVERSE REACTIONS

Adverse reactions are more frequent with doses of 3200 mg/day.

- Gastrointestinal: (>10%): [DYSPEPSIA], [DIARRHEA]. (1-10%): [NAUSEA], [VOMITING], [ABDOMINAL PAIN]. (0.1-1%): [GASTROINTESTINAL HEMORRHAGE], [GASTRIC ULCER], [DUODENAL ULCER], [ORAL CANCER]. (<0.1%): [INTESTINAL PERFORATION], [FLATULENCE], [CONSTIPATION], [ESOPHAGITIS], [ESOPHAGEAL OBSTRUCTION], exacerbation of diverticular disease, nonspecific hemorrhagic colitis, [ULCEROUS COLITIS] or [CROHN'S DISEASE], [MELENA ]. If gastrointestinal bleeding occurs, it could be a cause of anemia and [HEMATHEMESIS].

- Dermatological/Hypersensitivity: (1-10%): [EXANTEMATIC ERUPTIONS]. (0.1-1%): [URTICARIA], [PRURITO], [PURPURA] (including allergic purpura), [ANGIOEDEMA], [RHINITIS], [BRONCHIAL SPASM]. (<0.1%): [ANAPHYLAXIS]. (<0.01%): [ERITEMA MULTIFORME], [TOXIC EPIDERMAL NECROLYSIS], systemic lupus erythematosus, [ALOPECIA], [PHOTOSENSITIVITY REACTIONS], serious skin reactions such as [STEVENS-JOHNSON SYNDROME], [TOXIC EPIDERMAL NECROLYSIS] (syndrome Lyell) and allergic [VASCULITIS]; frequency unknown [DRESS SYNDROME] (which may include skin rash, swollen lymph nodes and [EOSINOPHILIA]) and acute generalized exanthematous pustulosis (AGEP).  

In most cases where [ASEPTIC MENINGITIS] has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor. It is manifested by severe headache, nausea, vomiting, fever, neck stiffness and a certain lightheadedness, possibly due to a hypersensitivity reaction. An increase in the intrathecal synthesis of IgG has been observed, with the presence of immune complexes in the cerebrospinal fluid.

Anaphylactic or anaphylactoid reactions usually occur in patients with a history of hypersensitivity to aspirin and other nonsteroidal anti-inflammatory drugs. This could also happen in patients who have not previously shown hypersensitivity to these drugs.

In case of a severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock may occur.

- Central nervous system: (1-10%): [ASTHENIA], [SOMNOLENCE], [CEFALEA], [DIZZINESS], [VERTIGO]. (0.1-1%): [INSOMNIA], [ANXIETY]. (<0.1%): reaction of [PSYCHOSIS], [NERVIOSISM], [IRRITABILITY], [DEPRESSION], [CONFUSION] or disorientation.

- Hematological: Bleeding time may be prolonged. The rare cases of hematological disorders observed correspond to [THROMBOCYTOPENIA], [LEUKOPENIA], [GRANULOCYTOPENIA], [PANCITOPENIA], [AGRANULOCITOSIS], [APLASTIC ANEMIA], [HEMOLITIC ANEMIA].

- Cardiovascular: There seems to be a greater predisposition on the part of patients with hypertension or renal disorders to suffer from [EDEMA]. It could appear [ARTERIAL HYPERTENSION] or [HEART FAILURE] (especially in elderly patients).

- Renal: [INCREASE IN UREIC NITROGEN] and [INCREASE IN SERUM CREATININE]. In exceptional cases, NSAIDs may be responsible for [ACUTE RENAL INSUFFICIENCY], [INTERSTITIAL NEPHRITIS], [GLOMEULONEPHRITIS], [RENAL MEDULLARY NECROSIS] or [NEPHROTIC SYNDROME], [PROTEINURIA], [HYPERPOTASEMIA], [HYPOPOTASEMIA] and edema. It has been observed in susceptible patients taking high doses of NSAIDs for prolonged periods of time. Patients at risk are those with heart, kidney, or liver failure, ascites, hyperreninemia, hyperaldosteronemia, shock, sepsis, systemic lupus erythematosus, dehydration, those treated with ACE inhibitors or diuretics, and the elderly.

- Hepatic: In rare cases [INCREASE OF TRANSAMINAS], [HEPATITIS] and [JAUNDICE] have been observed.

- Otological: Rarely, [TINNITUS].

- Ophthalmic: Optical reactions such as [BLURRED VISION], decreased visual acuity or changes in color perception ([DISCROMATOPSIA]) have been observed very rarely after the administration of ibuprofen, which remit spontaneously. Isolated cases of reversible toxic [AMBLYOPIA].

- In very rare cases, inflammations associated with infections could be aggravated.

OVERDOSE

Symptoms: Ibuprofen can give rise to toxic effects from doses of 80-100 mg/kg, with symptoms appearing after about 4 hours. In case of mild overdose, symptoms such as abdominal pain, nausea and vomiting, headache, drowsiness, lethargy, nystagmus, tinnitus and ataxia may appear. More severe symptoms rarely occur, although gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, renal failure, coma, adult respiratory distress, and transient apnea may occur in children after ingestion of large amounts.

Treatment: There is no specific antidote.

In case of mild overdose, for doses of up to 50 mg/kg, which are not expected to give rise to symptomatic intoxication, water will be administered to mitigate possible gastrointestinal reactions.

In case of larger overdoses, and if less than one hour has elapsed, the elimination of unabsorbed ibuprofen will be promoted through the administration of activated charcoal and forced emesis. Forced emesis is contraindicated in children who have ingested more than 400 mg/kg due to the risk of seizures and aspiration pneumonia. Gastric lavage is only recommended for potentially fatal overdoses.

If more than one hour has elapsed since the overdose, symptomatic treatment will be instituted, especially for hypotension, gastrointestinal bleeding and metabolic acidosis. Forced diuresis with urine alkalinization can be attempted.

Due to its high plasma protein binding, ibuprofen is not expected to be removed by haemodialysis.