Ibudol Rapid 400 Mg 20 Envelopes Granules For Oral Solution

Ibudol Rapid (400 Mg 20 Envelopes Granules For Oral Solution)

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 ibuprofen acid is converted to the pharmacologically active S(+)-enantiomer.

Linear pharmacokinetics in the 200-800 mg dosage range

- 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, which is why it is absorbed even more quickly, with a tmax of 20-30 min. After administration of a 200 mg dose, the Cmax is 15-20 mcg/ml.

The antipyretic effects begin after 1 hour, are maximal at 2-4 hours, and can be prolonged for periods of 6-8 hours.

For its part, up to 2 weeks of treatment may be required to achieve anti-inflammatory effects.

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 major 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 feces. The t1/2 is 2-4 h, and its elimination is complete after 24 h.

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

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

INDICATIONS

- Treatment of [PAIN] mild to moderate.

- Treatment of situations that occur with [PAIN] or [INFLAMATION], such as [HEADACHE], [MIGRAINE], [TOOTHINAL GIA], [DYSMENORRHEA], [PHARYNGITIS], [OTITIS], [TONSILLITIS] or [OSTEOMUSCULAR PAIN] ([MYALGIA], [MUSCLE CONTRACTURE], [LUMBALGIA]).

- Symptomatic treatment of [FEVER].

- Treatment of [JUVENILE RHEUMATOID ARTHRITIS].

- Treatment of acute or chronic rheumatic processes, such as [RHEUMATOID ARTHRITIS], [ANKYLOSING SPONDILITIS], [ARTHROSIS], [BURSITIS], [SINOVITIS] or [CAPSULITIS].

- Treatment of soft tissue injuries, such as sprains or [SPRAINS].

POSOLOGY

- Adults: 400 mg/6-8 h. Maximum dose 2,400 mg/24 h.
* Inflammatory processes: 1,200-1,800 mg/24 h, divided into 3-4 doses, although on occasions it could be maintained with 800-1,200 mg/24 h. Maximum dose 2,400 mg/24 h.
* Pain and fever: 800-1,600 mg/24 h, divided into 3-4 doses.
* Dysmenorrhea: 400 mg. Maximum dose 1,200 mg/24 h.
* Rheumatoid arthritis: higher doses may be required. Maximum dose 2,400 mg/24 h.
- Children and adolescents < 18 years:
* Adolescents > 12 years (> 40 kg): 400 mg/6-8 h. Maximum dose 1,600 mg/24 h. For patients with juvenile rheumatoid arthritis, higher doses may be needed, but 40 mg/kg/24 h should not be exceeded.
* Children < 12 years (< 40 kg): use presentations adapted to this age.
- Elderly: may require a dose reduction.
Administration with food : administer with food.
Duration of treatment : consult your doctor and/or pharmacist if symptoms worsen or persist for more than 5 days (pain) or 3 days (fever).
Forgotten dose : administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN RENAL FAILURE

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

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

DOSAGE IN LIVER FAILURE

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

- Severe hepatic impairment (Child-Pugh class C): contraindicated.

RULES FOR CORRECT ADMINISTRATION

Administration with food : administer with food.

- Granulated sachets: dissolve the contents of the sachet in half a glass of water, immediately drinking the suspension formed.

CONTRAINDICATIONS

- Hypersensitivity to ibuprofen or any component of the drug. Cases of cross hypersensitivity reactions have been described with other NSAIDs, 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 when receiving another NSAID or salicylates.

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

- [ALTERATIONS OF COAGULATION]. Ibuprofen has antiplatelet effects, although less potent and 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 [HEMORRHAGE] active, as well as in patients with [THROMBOCYTOPENIA].

- Perioperative pain in the setting of a coronary bypass.

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

- Severe hepatic impairment (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 long periods of time in the first two trimesters.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Ibuprofen is excreted in the urine, so in the case of renal failure, accumulation could occur, with the risk of poisoning. In addition, it could lead to a decrease in renal blood flow with reversible acute renal failure due to the inhibition of the synthesis of vasodilator prostaglandins, and cases of nephrotic syndrome and acute interstitial nephritis have even been described with prolonged treatments. 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. The use in severe insufficiency (CLcr < 30 ml/min) is contraindicated (See Contraindications).

- [LIVER FAILURE]. Due to its hepatic metabolism, in case of hepatic insufficiency, accumulation and intoxication could occur. 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. Its use in severe insufficiency (Child-Pugh class C) is contraindicated (see Contraindications).

- History of peptic ulcer. The use of an NSAID, including ibuprofen, has resulted in gastroduodenal ulcers, as well as bleeding and perforation, which 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 (H2 antihistamines or pump inhibitors) whenever possible.

These patients should be closely monitored, as well as those who are being treated with drugs that may promote bleeding, such as oral anticoagulants or antiplatelet agents.

If symptoms of active ulcer or gastrointestinal bleeding appear, treatment will be interrupted. Similarly, treatment with ibuprofen should not be started in people with active peptic ulcer (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 cases of 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 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 (=> 2,400 mg/24 h) has been associated with a greater 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 low 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 for symptom control 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 usually have an early onset, in the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or skin erythema are observed, treatment will be discontinued.

- [ASTHMA] chronic. In these patients, the appearance of hypersensitivity reactions with bronchospasm is especially frequent, so extreme precautions are recommended. If worsening 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 cross-allergy between NSAIDs has not been found. It has been more frequent in patients with [SYSTEMIC LUPUS ERYTHEMATOSO] and others [COLLAGENOSIS], although it has also been reported in some patients who did not suffer from these pathologies. In NSAID-treated patients who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered.

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

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains aspartame as an excipient. Aspartame contains a source of phenylalanine that may be harmful in the case of [PHENYLKETONURIA] (Phenylketonuria), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly. 10 mg of aspartame equivalent to 5.61 mg of phenylalanine.

- This medicine contains sucrose. Patients with hereditary [FRUCTOSE INTOLERANCE], glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

- This medicine contains sucrose. Its use in oral liquids and pharmaceutical forms that remain in contact with the mouth for some time can harm the teeth.

ADVICE TO THE PATIENT

- The patient must inform his doctor in case of experiencing 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 he has had any 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 treatments, possible signs and symptoms of ulceration or bleeding should be monitored. A history of esophagitis, gastritis and/or peptic ulcer should also be sought to ensure complete healing 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, formation of edema), 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 rarely 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) has been reported in association with ibuprofen-containing products. Ibuprofen should be discontinued at the first signs or symptoms of severe 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 without increasing therapeutic efficacy. In addition, ibuprofen could reduce the antiplatelet efficacy of aspirin when co-administered. If the administration of both drugs is required, it is advisable to separate the doses (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 nonsteroidal anti-inflammatory drugs.

- Oral anticoagulants, heparin: possible increased anticoagulant effect, with risk of bleeding. Periodic monitoring of coagulation indices is advised.

- Sulfonylurea antidiabetics (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 (ACEI, Beta-blockers): possible reduction of the antihypertensive effect.

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

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

- Antiplatelet agents, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal bleeding in particular. Manage with caution.

- Corticosteroids: possible increase in the incidence of gastric discomfort. However, the concurrent use with glucocorticoids in the treatment of osteoarthritis may provide additional therapeutic benefit and allows the dosage of glucocorticoid 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 reduced natriuretic and diuretic effect. May reduce the antihypertensive action of thiazide diuretics.

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

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

- Hydralazine: possible decrease in the hypotensive effect.

- Iloprost: possible increased risk of bleeding.

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

- Methotrexate (administered at doses of 15 mg/week or higher): possible increase in methotrexate plasma levels, with risk of toxicity, sometimes very serious. The severity largely depends 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 they may reduce its effects.

- Paracetamol: 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 bleeding time.

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

- Ticlopidine: possible increased risk of bleeding.

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

PREGNANCY

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

Safety in humans: * First and second trimester of pregnancy.

From the 20th week of pregnancy onwards, ibuprofen can cause oligohydramniosis as a consequence of fetal renal dysfunction. This can occur shortly after the start of treatment and is generally reversible upon discontinuation. In addition, cases of constriction of the ductus arteriosus have been reported after treatment in the second trimester, most of which were reversed after cessation of treatment. Therefore, during the first and second trimesters of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman trying to become pregnant, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be reduced as much as possible. Prenatal monitoring for oligohydramniosis and ductus arteriosus constriction should be considered after ibuprofen exposure for several days from gestational week 20 onwards. Ibuprofen should be discontinued if oligohydramniosis or constriction of the ductus arteriosus is found.

2) Third trimester of pregnancy

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:

- Cardiopulmonary toxicity (constriction/premature closure of the ductus arteriosus and pulmonary hypertension)

- Renal dysfunction, which can progress to renal failure with oligo-hydroamniosis.

- Possible prolongation of bleeding time, due to an antiplatelet effect that can occur even at very low doses.

- Inhibition of uterine contractions, which can cause delay or prolongation of labor (with a greater tendency to bleeding in the mother and in the child).

Effects on fertility: Ibuprofen may impair female fertility and is not recommended in women trying to conceive. In women having difficulty conceiving or undergoing fertility investigation, discontinuation of this drug should be considered.

LACTATION

Safety in animals: no data available.

Safety in humans: Ibuprofen and its metabolites are excreted in low concentrations in breast milk. It does not produce serious adverse reactions in children, therefore it can be used during the lactation period to treat pain and fever.

CHILDREN

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

ADVANCED AGE

No specific problems have been described in the elderly that require a dose readjustment. Elderly patients have a higher incidence of gastrointestinal adverse reactions to NSAIDs, especially bleeding and perforation. Therefore, it should be used with caution.

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 BLEEDING], [GASTRIC ULCER], [DUODENAL ULCER], [ORAL THRUES]. (<0.1%): [INTESTINAL PERFORATION], [FLATULENCE], [CONSTIPATION], [ESOPHAGITIS], [ESOPHAGIC OBSTRUCTION], exacerbation of diverticular disease, nonspecific hemorrhagic colitis, [ULCEROUS COLITIS] or [CROHN'S DISEASE], [MELENA]. If gastrointestinal bleeding occurs, it could cause anemia and [HEMATEMESIS].

- Dermatological/Hypersensitivity: (1-10%): [EXANTEMATIC ERUPTIONS]. (0.1-1%): [URTICARIA], [PRURITUS], [PURPURA] (including allergic purpura), [ANGIOEDEMA], [RHINITIS], [BRONCHIAL SPASM]. (<0.1%): [ANAPHYLAXIS]. (<0.01%): [ERYTHEMA MULTIFORME], [TOXIC EPIDERMAL NECROLYSIS], systemic lupus erythematosus, [ALOPECIA], [PHOTOSENSITIVITY REACTIONS], severe skin reactions such as [STEVENS-JOHNSON SYNDROME], [TOXIC EPIDERMAL NECROLYSIS] (Lyell syndrome) and allergic [VASCULITIS] ; unknown frequency [DRESS SYNDROME] (which may include rash, swollen lymph nodes, and [OESINOPHILIA]) 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 some drowsiness, possibly due to a hypersensitivity reaction. An increase in intrathecal IgG synthesis 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 severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock may appear.

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

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

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

- Renal: [INCREASE IN UREIC NITROGEN] and [INCREASE IN SERUM CREATININE]. In exceptional cases, NSAIDs may be responsible for [ACUTE RENAL FAILURE], [INTERSTITIAL NEPHRITIS], [GLOMERULONEPHRITIS], [RENAL MEDULLAR NECROSIS] or [NEPHROTIC SYNDROME], [PROTEINURIA], [HYPERKALEMIA], [HYPOKALEMIA] 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 [INCREASED TRANSAMINASES], [HEPATITIS] and [JAUNDICE] have been observed.

- Otological: rarely, [TINNITUS].

- Ophthalmic: Very rarely have been observed optical reactions, such as [BLURRY VISION], decreased visual acuity or changes in color perception ([DYSCROMATOPSIA]) 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 cause 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 serious symptoms rarely appear, although gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, renal failure, coma, respiratory distress in adults, and transient apnea in children may occur after ingesting large amounts.

Treatment: There is no specific antidote.

In light overdoses, for doses of up to 50 mg/kg, which are not expected to give rise to symptomatic poisoning, water will be administered to mitigate possible gastrointestinal reactions.

In case of major overdose, and if less than an hour has elapsed, the elimination of unabsorbed ibuprofen will be favored by administering 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 those overdoses that could be potentially fatal.

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

Due to its high binding to plasma proteins, it is not expected that ibuprofen can be removed by hemodialysis.

Leaflet Ibudol Rapid 400 Mg 20 Envelopes Granules For Oral Solution