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ACTION AND MECHANISM A non-steroidal anti-inflammatory drug (NSAID) belonging to the arylpropionic group, which acts by preventing the synthesis of prostaglandins, through the competitive and reversible inhibition of cyclooxygenase activity, an enzyme that converts arachidonic acid into prostaglandins. CONTRAINDICATIONS - Known hypersensitivity to flurbiprofen or [NSAID ALLERGY]. - Patients with a history of hypersensitivity to acetylsalicylic acid or other NSAIDs, which includes patients who have experienced asthma attacks, acute rhinitis, urticaria or angioneurotic edema after using acetylsalicylic acid or other NSAIDs. - [GASTROINTESTINAL BLEEDING], [PEPTIC ULCER] active. - Severe renal insufficiency (CrCl < 30 ml/min). - Severe liver failure (Child-Pugh class C). - Severe [HEART FAILURE]. - Third trimester of pregnancy. ADVANCED AGE Elderly patients experience a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation. There is no recommendation for their use in these patients due to insufficient data. PREGNANCY Animal safety: In rats exposed to doses of 0.4 mg/kg/day or more, during pregnancy, an increased risk of adverse effects was observed. incidence of pregnancy termination. Safety in humans: Epidemiological studies have shown an increased risk of miscarriage, heart defects, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk appears to increase with the dose and duration of treatment. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to the following conditions: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension), and renal dysfunction, which can progress to renal failure with oligohydramnios. Furthermore, they can expose the mother and child at the end of pregnancy to the following conditions: possible prolongation of bleeding time due to an antiplatelet effect that can occur even at very low doses, and inhibition of uterine contractions, which can lead to delayed or prolonged labor. Therefore, this medication is contraindicated during the last trimester of pregnancy. During the first and second trimesters, it is only acceptable if there are no safer therapeutic alternatives, and the benefits outweigh the potential risks. Effects on fertility: there is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may It decreases female fertility by affecting ovulation. This is reversible after discontinuing treatment. INDICATIONS - Short-term symptomatic relief of [SORE THROAT]. INTERACTIONS - NSAIDs, including antiplatelet doses of acetylsalicylic acid. Increases the risk of peptic ulcer and gastric bleeding. -Aliskiren. Possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with impaired 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. - SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram). There is an increased risk of bleeding in general, and gastrointestinal bleeding in particular, especially in the elderly and patients with a history of gastrointestinal bleeding. - Diuretics. Flurbiprofen may counteract the diuretic and antihypertensive effects. Periodic blood pressure monitoring is recommended. - Glitazones (pioglitazone, rosiglitazone). Theoretical risk of potentiating edema, which both glitazones and NSAIDs can cause. Caution and monitor for possible signs of fluid retention and heart failure (swollen ankles, dyspnea). - Antiplatelet agents, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal bleeding in particular. Administer with caution. - Potassium supplements: possible increase in potassium levels, with risk of hyperkalemia. LACTATION Animal safety: no data available. Safety in humans: Flurbiprofen concentrations in breast milk have been detected at levels below 0.7% of maternal serum levels. It is highly unlikely that the amount excreted will have adverse effects on the infant. However, caution is advised when using this medication in breastfeeding mothers. CHILDREN Tablets and pills are contraindicated in children < 12 years. GUIDELINES FOR PROPER ADMINISTRATION - Lozenges: suck slowly in your mouth. To avoid local irritation, keep moving while dissolving. POSOLOGY DOSAGE FOR LOZENGES - Adults and adolescents from 12 years: 1 pill/3-6 h, up to a maximum of 5 pills/24 h. - Children < 12 years: not recommended or contraindicated. - Elderly: clinical experience is very limited, and does not allow for the establishment of specific dosage recommendations. Treatment duration : maximum 3 days. DOSAGE IN HEPATIC INSUFFICIENCY - Mild to moderate hepatic impairment (Child-Pugh classes A and B): no dosage adjustment required. - Severe hepatic impairment (Child-Pugh class C): contraindicated. DOSAGE IN RENAL INSUFFICIENCY - Mild to moderate renal insufficiency (ClCr 30-90 ml/min): no dosage adjustment required. - Severe renal insufficiency (ClCr < 30 ml/min): contraindicated. PRECAUTIONS - [RENAL INSUFFICIENCY]. Use is contraindicated in severe renal insufficiency. NSAIDs may lead to decreased renal blood flow with reversible acute renal failure due to inhibition of vasodilatory prostaglandin synthesis, and cases of nephrotic syndrome and acute interstitial nephritis have even been reported with prolonged treatment. Patients at higher risk of renal insufficiency are those with pre-existing renal insufficiency, the elderly, or those in conditions that may reduce renal blood flow, such as [HYPOVOLEMIA], [DEHYDRATION], low-sodium diets, [HEART FAILURE], hepatic insufficiency, [HEPATIC CIRRHOSIS], or treatment with diuretics, ACE inhibitors, or ARBs. In high-risk patients, during prolonged treatment, it is recommended to determine renal function (serum creatinine, creatinine clearance, CLcr) before initiating treatment and periodically thereafter. If renal function worsens, a dose reduction may be necessary. - [HEPATIC INSUFFICIENCY]. Use in severe insufficiency is contraindicated. - Gastrointestinal toxicity. Treatment with NSAIDs has resulted in gastroduodenal ulcers, as well as life-threatening bleeding and perforation. The risk of ulcers is higher with high-dose treatments or treatments lasting long periods, in patients with a history of peptic ulcers, especially if they have previously experienced gastrointestinal bleeding or perforation due to NSAIDs, as well as in smokers, chronic alcoholics, or elderly or debilitated patients. However, short-term treatment is not without risks either. As a general rule to reduce gastric damage, it is advisable to take any NSAID with food. Furthermore, in at-risk groups, it is recommended to start treatment with the lowest possible dose and, whenever possible, to combine it with an anti-ulcer drug (H2 blocker or PPI). High-risk patients, as well as those receiving medications that may promote or worsen gastrointestinal bleeding, such as oral anticoagulants, antiplatelet agents, corticosteroids, or SSRIs, should be closely monitored. If a peptic ulcer or gastrointestinal bleeding occurs, treatment should be discontinued. Furthermore, it should be used with caution in individuals with inflammatory bowel disease (IBD), in whom NSAIDs could trigger an attack. - Cardiovascular diseases. NSAIDs may cause fluid retention and edema, which could increase blood pressure and worsen symptoms in patients with cardiovascular diseases. Individual assessment of the benefit/risk ratio is recommended in patients with hypertension, heart failure, ischemic heart disease, cerebral ischemia, stroke, or peripheral artery disease, as well as in patients with cardiovascular risk factors such as dyslipidemia, diabetes, or smoking. NSAIDs should always be used at the lowest effective dose and for the shortest possible duration. - Hepatic effects. Patients with [HEPATIC INSUFFICIENCY] may experience increased plasma levels. Furthermore, due to its high plasma protein binding, free plasma levels may also be increased, as has been observed in cases of [HEPATIC CIRRHOSIS]. On the other hand, the use of NSAIDs has occasionally been associated with the development of liver problems, such as elevated transaminases, jaundice, and hepatitis, which can become serious and even fatal. Due to the risk of toxicity, it is advised that patients with liver disease use this medication at the lowest effective dose and have their liver function (transaminases, bilirubin) monitored periodically for any signs of liver damage. Its use is contraindicated in severe hepatic impairment (Child-Pugh class C) due to a lack of safety data. - 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 begin early, within the first month of treatment. If symptoms of hypersensitivity, mucosal lesions, or skin erythema are observed, treatment should be discontinued. - [HYPERSENSITIVITY REACTIONS]. Administration of any NSAID has been associated with the occurrence of allergic reactions. Cases of cross-hypersensitivity between different NSAIDs, as well as between NSAIDs and salicylates, have been reported; therefore, patients with a history of [NSAID ALLERGY] to other than this active ingredient or [SALICYLATE ALLERGY] should use this active ingredient with extreme caution. It is recommended to avoid its use in patients in whom a salicylate or an NSAID has previously caused severe allergic reactions, including [ASTHMA], [NASAL POLYPS], [ANGIOEDEMA] or [RHINITIS], because there is an increased risk of life-threatening anaphylaxis. [ASTHMA]. Asthmatic patients are more susceptible to experiencing bronchospasm when an NSAID is administered. They may also be more susceptible to anaphylactic reactions after NSAID administration. - [COAGULATION DISORDERS]. NSAIDs have antiplatelet activity, although less than that of acetylsalicylic acid. - [ASEPTIC MENINGITIS]. Rare cases of aseptic meningitis have been reported in patients taking NSAIDs, with fever and coma, probably due to a hypersensitivity reaction, although no cross-allergy between NSAIDs has been found. This meningitis appears to be more frequent in patients with collagen vascular diseases such as systemic lupus erythematosus, although it has also been reported in some patients without these conditions. In patients treated with NSAIDs who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered. - Ophthalmological conditions. NSAIDs have been associated with the appearance of ocular reactions, such as blurred vision, loss of vision, alteration in color vision, scotoma or retinal alterations. - [FEMALE INFERTILITY]: Like other NSAIDs, it may decrease female fertility and is not recommended for use in women who wish to become pregnant. In women who have difficulty conceiving or are being evaluated for infertility, discontinuation of the NSAID should be considered. PRECAUTIONS RELATING TO EXCIPIENTS This medicine contains isomalt. Patients with hereditary fructose intolerance should not take this medicine. ADVERSE REACTIONS The following adverse reactions are related to the short-term use of flurbiprofen at over-the-counter doses. - Blood: (<0.1%): [ANEMIA]. (<0.01%): hematopoietic disorders, ([HEMOLYTIC ANEMIA], [APLASTIC ANEMIA], [NEUTROPENIA], [THROMBOCYTOPENIA], [AGRANULOCYTOSIS]). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bruising and bleeding. - Nervous system: (<1%): [HEADACHE] and [DIZZINESS]. (0.1-0.01%): [INSOMNIA] - Respiratory: (0.1-0.01%): [DYSPNEA]. Exacerbation of [ASTHMA] and [BRONCHOSPASM]. - Gastrointestinal: (>10%): Oral discomfort (burning or tingling sensation in the mouth). (1-10%): Abdominal pain, diarrhea, dry mouth, oral ulcer, nausea, and oral paresthesia. (<1%): Dyspepsia, flatulence, and vomiting. (0.1-0.01%): Gastric perforation and gastric ulcer or duodenal ulcer. - Renal and urinary: (<0.1%): [INTERSTITIAL NEPHRITIS], [NEPHROTIC SYNDROME] and renal failure. ADVERSE REACTIONS RELATED TO EXCIPIENTS This medicine contains isomalt. Daily doses above 10 g may produce a mild laxative effect and lead to diarrhea. OVERDOSE - Symptoms : the symptoms of overdose are unknown; similar drugs have produced gastrointestinal disturbances (vomiting, anorexia, abdominal pain), neurological disturbances (drowsiness, vertigo, disorientation, headache). - Measures to be taken : Gastric aspiration and lavage, administration of adsorbent charcoal, urine alkalinization, monitoring and maintenance of vital signs, symptomatic treatment of gastrointestinal irritation, hypotension, respiratory depression and seizures, with monitoring of renal and hepatic functions and detection in feces of possible gastrointestinal bleeding.
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