Ibufen 400 Mg 20 Coated Tablets

Ibufen (Ibuprofen 400 Mg 20 Coated Tablets) 

ACTION AND MECHANISM
- Analgesic, anti-inflammatory, antipyretic. Ibuprofen is a derivative of propionic acid, with anti-inflammatory, analgesic and antipyretic activity. Its action mechanisms 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 these prostaglandins.

PHARMACOKINETICS
Oral, parenteral use:

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

- 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 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 after 1 hour, peak at 2-4 hours, and can last for periods of 6-8 hours.

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

Effect of food: they delay absorption 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 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 majority are 2- [4- (2-hydroxy-2-methyl-propyl) -phenyl] propionic acid and 2- [4- (carboxypropyl) -phenyl] propionic acid

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

- Hepatic insufficiency: in moderate insufficiency (Child-Pugh class B) the 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.

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INDICATIONS
- Treatment of [PAIN] from mild to moderate.

- Treatment of situations that occur with [PAIN] or [INFLAMMATION], such as [HEADACHE], [MIGRAINE], [ODONTALGIA], [DYSMENORRHEA], [PHARINGITIS], [OTITIS], [TONSILITIS] or [OSTEOMUSCULAR PAIN] ([ MIALGIA], [CONTRACTURE], [LUMBALGIA]).

- Symptomatic treatment of [FEVER].

DOSAGE
- Adults: 200 mg / 4-6 h. If necessary, increase to 400 mg / 6-8 h. Maximum dose 1,200 mg / 24 h.
- Children and adolescents <18 years:
* Adolescents from 12 years: 200 mg / 4-6 h. Maximum dose 1,200 mg / 24 h.
* Children 8-12 years: 200 mg / 6-8 h. Maximum dose 800 mg / 24 h.
* Children <8 years: use presentations adapted to this age.
- Elderly: may require a decrease in dose.
Administration with food: administer together 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 LIVER INSUFFICIENCY
- 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 together with food.

- Tablets and capsules: swallow with a glass of water.

CONTRAINDICATIONS
- Hypersensitivity to ibuprofen or any component of the drug. Cases of cross-hypersensitivity reactions with other NSAIDs have been described, therefore 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 other NSAIDs or salicylates.

- Active or recurrent [PEPTIC ULCER], 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, so it could increase the risk of gastrointestinal bleeding and perforation.

- [DISORDERS OF COAGULATION]. Ibuprofen has antiplatelet effects, although less potent and long-lasting than acetylsalicylic acid. Therefore, it may increase the bleeding time and should therefore be used with caution in patients with active [BLEEDING DIATESIS] or [BLEEDING].

- Perioperative pain in the context 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 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 make these conditions worse.

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

PRECAUTIONS
- [KIDNEY INSUFFICIENCY]. Ibuprofen is eliminated in the urine, so in case of kidney failure, accumulation could occur, with the risk of poisoning. Furthermore, it could lead to a decrease in renal blood flow with reversible acute renal failure due to 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, accumulation and intoxication could occur in case of liver failure. In patients with mild to moderate impairment (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. Use in severe impairment (Child-Pugh class C) is contraindicated (See Contraindications).

- History of peptic ulcer. The use of an NSAID, including ibuprofen, has led to gastroduodenal ulcers, as well as bleeding and perforation that could be fatal. The risk of ulcer is increased in treatment 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. Furthermore, in risk groups it is advisable to start treatment with the lowest possible dose, and to associate whenever possible an antiulcer drug (h3 antihistamines or pump inhibitors).

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

In case of symptoms of active ulcer or gastrointestinal bleeding, treatment will be stopped. Similarly, ibuprofen treatment should not be started in people with active peptic ulcer (See Contraindications).

- [INFLAMMATORY INTESTINAL DISEASE]. NSAIDs could precipitate symptomatic crises of diseases such as Crohn's disease or ulcerative colitis, so it is advised to use with caution, and avoid their use in case 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 worsening of [ARTERIAL HYPERTENSION], especially in cases in the 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 (= /> 2,400 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 CARDIOPATIA], [PERIPHERAL ARTERIOPATIA], [STROKE] or [BRAIN ISCHEMIA].

Before starting a long-term treatment with ibuprofen, and especially if high doses are required, 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 control of symptoms and for the shortest period of time possible.

- Skin reactions. The use of NSAIDs has caused very rare but life-threatening serious adverse reactions, such as exfoliative dermatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome. These adverse reactions usually start early, in the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or cutaneous erythema are observed, the treatment will be suspended.

- [ASTHMA] chronic. In these patients, the appearance of hypersensitivity reactions with bronchospasm is especially frequent, so extreme precautions are recommended. If a 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 has been found between NSAIDs. It has been more frequent in patients with [SYSTEMIC LUPUS ERYTHEMATOSUS] and others [COLLAGENOSIS], 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 suspicion of it in preterm children.

PRECAUTIONS RELATING TO EXCIPIENTS
- This medicine contains lactose. Patients with hereditary [LACTOSE INTOLERANCE] or galactose, Lapp lactase deficiency, or glucose or galactose malabsorption, should not take this medicine.

ADVICE TO THE PATIENT
- The patient should inform their doctor in case 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 he has 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 for 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 for possible signs of hydrosaline retention (eg, edema formation), especially in patients with hypertension or heart failure.

INTERACTIONS
- 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 the therapeutic efficacy. Furthermore, ibuprofen could reduce the antiplatelet efficacy of acetylsalicylic acid when co-administered. If the administration of both drugs is needed, it is advisable to distance 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 kidney function.

- Food: food delays Tmax (from ± 2 h fasting to ± 3 h after taking food), 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 the anticoagulant effect, with risk of bleeding. Periodic checks of coagulation indices are advised.

- Sulfonylureas antidiabetic drugs (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 in particular, especially in the elderly and patients with a history of digestive bleeding.

- Antihypertensive (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 can increase the nephrotoxicity of cyclosporine.

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

- Corticosteroids: possible increase in the incidence of gastric discomfort. However, the concomitant use of glucocorticoids in the treatment of osteoarthritis may provide additional therapeutic benefit and can reduce glucocorticoid dosage.

- 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 hyperkalaemia. 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 for 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 increasing the 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 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 in the 8-12 days after the administration of mifepristone since these can reduce the effects of it.

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

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

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

- Ticlopidine: possible increased risk of bleeding.

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

PREGNANCY
FDA Category C (quarters 1 and 2); FDA Category D (Quarter 3).

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

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 treatments.

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 antiplatelet effects, the bleeding time could be prolonged, with possible fetal involvement and risks in childbirth. Another possible effect that could appear is the reduction and even cancellation of uterine contractility, causing an abnormal delay in delivery and a non-physiological prolongation of pregnancy.

It is unknown whether the timely administration of an NSAID could pose a risk to the fetus.

The use of ibuprofen during the first two trimesters of pregnancy is only accepted if, 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.

LACTATION
After 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, manufacturers advise not to use during lactation, due to the risk of inhibiting cyclooxygenase in the infant.

The American Academy of Pediatrics considers the use of ibuprofen compatible with breastfeeding.

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 appear 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 a reduction in the effectiveness of antihypertensive treatments. It is recommended to use with caution, using the lowest effective dose possible.

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 AFTAS]. (<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 be the cause of anemia and [HEMATEMESIS].

- Dermatological / Hypersensitivity: (1-10%): [EXANTEMATIC ERUPTIONS]. (0.1-1%): [URTICARIA], [ITCHING], [PURPLE] (including allergic purpura), [ANGIOEDEMA], [RHINITIS], [BRONCHIAL SPASM]. (<0.1%): [ANAPHYLAXY]. (<0.01%): [ERYTHEMA MULTIFORME], [TOXIC EPIDERMAL NECROLYSIS], systemic lupus erythematosus, [ALOPECIA], [PHOTOSENSITIVITY REACTIONS], severe skin reactions such as [STEVENS-JOHNSON SYNDROME], [NECROLYSIS EPIDERMICA TOX syndrome] Lyell) and [VASCULITIS] allergic; frequency not known [DRESS SYNDROME] (which may include rash, swollen lymph nodes and [EOSINOPHILIA]).

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 the intrathecal synthesis of IgG has been observed, with the presence of immune complexes in the cerebrospinal fluid.

Anaphylactic or anaphylactoid reactions normally occur in patients with a history of hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. This could also happen in patients who have not previously shown hypersensitivity to these drugs.

In the event of a 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], [HEADACHE], [DIZZINESS], [VERTIGO]. (0.1-1%): [INSOMNIA], [ANXIETY]. (<0.1%): reaction of [PSYCHOSIS], [NERVIOSISM], [IRRITABILITY], [DEPRESSION], [CONFUSION] or disorientation.

- Hematological: The bleeding time may be prolonged. The rare cases of haematological disorders observed correspond to [THROMBOCYTOPENIA], [LEUCOPENIA], [GRANULOCITOPENIA], [PANCITOPENIA], [AGRANULOCYTOSIS], [APLASIC ANEMIA], [HEMOLITIC 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 SERIAL CREATININE]. In exceptional cases, NSAIDs may be responsible for [ACUTE KIDNEY FAILURE], [INTERSTICIAL NEPHRITIS], [GLOMERULONEFRITIS], [RENAL MEDULAR NECROSIS] or [NEPHROTIC SYNDROME], [PROTEINURIA], [HYPERPOTASEMIA], [HYPOPOTASEMIA], [HYPOPOTASEMIA], and [HYPOPOTASEMIA]. It has been observed in susceptible patients taking high doses of NSAIDs for long periods of time. Risk patients 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, [TRANSAMINASE INCREASE], [HEPATITIS] and [JAUNDICE] have been observed.

- Otological: Rarely, [TINNITUS].

- Ophthalmic: Very rarely, optical reactions such as [BLURRED VISION], decreased visual acuity or changes in color perception ([DYSCHROMATOPSIA]) have been observed after ibuprofen administration, which resolve spontaneously. Isolated cases of reversible toxic [AMBLIOPIA].

- In very rare cases inflammation associated with infections may 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 severe symptoms rarely appear, although gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, kidney failure, coma, adult respiratory distress, and transient apnea in children may occur after ingesting large amounts.

Treatment: There is no specific antidote.

In the event of mild overdoses, for doses of up to 50 mg / kg, which are not expected to lead to symptomatic intoxication, water will be administered to mitigate possible gastrointestinal reactions.

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

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

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

Ibufen 400 Mg Leaflet 20 Coated Tablets