Instructions for Loxidol film-coated tablets 15 mg No. 10
Composition
active ingredient: meloxicam;
1 tablet contains meloxicam 15 mg;
Excipients: microcrystalline cellulose; sodium citrate; lactose monohydrate; crospovidone; povidone K30; colloidal anhydrous silicon dioxide; magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round, flat tablets of light yellow color with engraving "LOX 15" on one side.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Oxycodone. ATX code M01A C06.
Pharmacological properties
Pharmacodynamics.
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) from the oxicam group with anti-inflammatory, analgesic, and antipyretic properties.
Meloxicam has shown high anti-inflammatory activity in all standard models of inflammation. As with other NSAIDs, its exact mechanism of action remains unknown. However, there is a common mechanism of action for all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, which are mediators of inflammation.
Pharmacokinetics.
When administered orally in therapeutic doses, meloxicam exhibits linear pharmacokinetics.
Absorption
Meloxicam is almost completely absorbed from the gastrointestinal tract. Absolute bioavailability after oral administration is 90%. Simultaneous food intake or the use of inorganic antacids does not affect its absorption.
After a single oral dose of meloxicam, peak plasma levels are reached within 5-6 hours. After repeated dosing, steady state is reached within 3-5 days of starting the drug.
When administered orally at a dose of 15 mg meloxicam once daily at steady state, plasma concentrations range from 0.8 to 2.0 mg/l (15 mg) (Cmin-Cmax). Mean steady-state plasma concentrations of meloxicam are achieved within 5 to 6 hours after oral administration.
Distribution
Meloxicam is highly bound to plasma proteins, mainly albumin (99%). Meloxicam penetrates into the synovial fluid, where its concentration is half that in plasma.
The volume of distribution after multiple oral doses averages 16 L and shows interindividual variation of 11-32%.
Metabolism
Meloxicam undergoes extensive biotransformation in the liver. Four different metabolites of meloxicam, which are pharmacodynamically inactive, have been identified in the urine. The main metabolite 5'-carboxymeloxicam (60% of the dose) is formed by oxidation of the intermediate metabolite 5'-hydroxymethylmeloxicam, which is also excreted to a lesser extent (9% of the dose). In vitro studies suggest that CYP 2C9 plays an important role in the metabolism process, while CYP 3A4 isoenzymes contribute to a lesser extent. Peroxidase activity in patients is probably responsible for the other two metabolites, which account for 16% and 4% of the administered dose, respectively.
Breeding
Meloxicam is excreted mainly as metabolites in equal parts with urine and feces. Less than 5% of the daily dose is excreted unchanged in the feces, a small amount is excreted in the urine. The half-life varies from 13 to 25 hours after oral, intramuscular and intravenous administration. Plasma clearance is approximately 7-12 ml/min after a single oral dose, intravenous or rectal administration.
Special patient groups
Elderly patients
In elderly male patients, mean pharmacokinetic parameters were similar to those in young male volunteers. In elderly female patients, the area under the pharmacokinetic curve (AUC) was higher and the elimination half-life was longer compared to those in young volunteers of both sexes. Mean steady-state plasma clearance in elderly patients was slightly lower than in young volunteers.
Patients with hepatic/renal insufficiency
Mild to moderate hepatic and renal impairment do not significantly affect the pharmacokinetics of meloxicam. Patients with moderate renal impairment had significantly higher total clearance. Reduced plasma protein binding was observed in patients with end-stage renal disease. In end-stage renal disease, an increase in the volume of distribution may lead to an increase in free meloxicam concentrations (see sections 4.3 and 4.4).
Indication
Short-term symptomatic treatment of exacerbations of osteoarthritis.
Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.
Contraindication
Hypersensitivity to the active substance, other components of the medicinal product or to active substances with a similar effect, such as NSAIDs, acetylsalicylic acid.
History of hypersensitivity symptoms (including asthma symptoms, nasal polyps, angioedema, urticaria) to acetylsalicylic acid and NSAIDs.
History of gastrointestinal bleeding or perforation associated with previous NSAID therapy.
Gastrointestinal bleeding, history of cerebrovascular bleeding or other blood clotting disorders.
Severe heart, liver, or kidney failure (without dialysis).
Treatment of perioperative pain in coronary artery bypass grafting (CABG).
Third trimester of pregnancy.
Children under 16 years of age.
Interaction with other medicinal products and other types of interactions
Risks associated with hyperkalemia
Some medicinal products or therapeutic classes may cause hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, NSAIDs, (low molecular weight or unfractionated) heparins, ciclosporin, tacrolimus and trimethoprim.
The onset of hyperkalemia may depend on whether there are associated factors. The risk of hyperkalemia is increased if the above-mentioned drugs are used concomitantly with meloxicam.
Pharmacodynamic interactions
Other non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid: Combination with other NSAIDs is not recommended (see section 4.4), including acetylsalicylic acid at doses ≥ 500 mg per dose or ≥ 3 g total daily dose.
Corticosteroids (e.g. glucocorticoids): Concomitant use with corticosteroids requires caution due to increased risk of gastrointestinal bleeding or ulceration.
Anticoagulants or heparin. The risk of bleeding is significantly increased due to inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs may enhance the effects of anticoagulants such as warfarin (see section "Special precautions for use"). The concomitant use of NSAIDs and anticoagulants or heparin is not recommended in geriatric practice or at therapeutic doses (see section "Special precautions for use").
In other cases (e.g. at prophylactic doses) the use of heparin requires caution due to the increased risk of bleeding. Careful monitoring of the international normalized ratio (INR) is necessary if the combination is proven to be unavoidable.
Thrombolytic and antiplatelet drugs: increased risk of bleeding due to inhibition of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and angiotensin II antagonists. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant use of ACE inhibitors or angiotensin II antagonists and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such a combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter (see section 4.4).
Other antihypertensive drugs (e.g. beta-blockers). As with the following drugs, the antihypertensive effect of beta-blockers may be reduced (due to inhibition of vasodilating prostaglandins).
Calcineurin inhibitors (e.g., cyclosporine, tacrolimus). The nephrotoxicity of calcineurin inhibitors may be potentiated by NSAIDs due to mediation of renal prostaglandin effects. Renal function should be monitored during treatment. Close monitoring of renal function is recommended, especially in elderly patients.
Deferasirox
Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal adverse reactions. Caution should be exercised when combining these drugs.
Pharmacokinetic interaction: effect of meloxicam on the pharmacokinetics of other drugs
Methotrexate. NSAIDs may reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, concomitant use of NSAIDs is not recommended in patients receiving high doses of methotrexate (more than 15 mg/week) (see section "Special warnings and precautions for use"). The risk of interaction between NSAIDs and methotrexate should also be considered in patients receiving low doses of methotrexate, in particular in patients with impaired renal function. If combined treatment is necessary, blood count and renal function should be monitored. Caution should be exercised when NSAIDs and methotrexate are taken for 3 consecutive days, as plasma levels of methotrexate may increase and toxicity may increase. Although the pharmacokinetics of methotrexate (15 mg/week) were not affected by concomitant treatment with meloxicam, it is believed that the hematological toxicity of methotrexate may be increased by treatment with NSAIDs (see information above) (see section "Adverse reactions").
Pemetrexed. When meloxicam is co-administered with pemetrexed in patients with creatinine clearance between 45 and 79 ml/min, meloxicam should be discontinued 5 days before, on the day of, and for 2 days after pemetrexed administration. If the combination of meloxicam and pemetrexed is necessary, patients should be closely monitored, especially for myelosuppression and gastrointestinal adverse reactions. In patients with severe renal impairment (creatinine clearance below 45 ml/min), the co-administration of meloxicam and pemetrexed is not recommended.
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), doses of 15 mg meloxicam may reduce the elimination of pemetrexed and, therefore, increase the incidence of adverse reactions associated with pemetrexed. Therefore, caution should be exercised when prescribing 15 mg meloxicam concomitantly with pemetrexed in patients with normal renal function (creatinine clearance ≥ 80 ml/min).
Pharmacokinetic interaction: effect of other drugs on the pharmacokinetics of meloxicam
Cholestyramine: Cholestyramine accelerates the elimination of meloxicam due to impaired intrahepatic circulation, so the clearance of meloxicam increases by 50% and the half-life decreases to 13 ± 3 hours. This interaction is clinically significant.
Pharmacokinetic interaction: effect of the combination of meloxicam and other drugs on pharmacokinetics
Oral antidiabetic agents (sulfonylureas, nateglinide)
Meloxicam is almost completely eliminated by hepatic metabolism, approximately two-thirds of which is mediated by cytochrome (CYP) P450 enzymes (primary CYP 2C9 and minor CYP 3A4) and one-third by other pathways, such as peroxidase oxidation. The possibility of pharmacokinetic interactions should be considered when meloxicam is co-administered with medicinal products that are known to inhibit or are metabolised by CYP 2C9 and/or CYP 3A4. Interactions mediated by CYP 2C9 may be expected in combination with medicinal products such as oral antidiabetic agents (sulfonylureas, nateglinide); this interaction may lead to increased plasma levels of these medicinal products and meloxicam. Patients taking meloxicam and sulphonylureas or nateglinide should be closely monitored for hypoglycaemia.
No clinically significant pharmacokinetic interaction was found when co-administered with antacids, cimetidine, and digoxin.
Children
Interaction studies were conducted only in adults.
Application features
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control the disease.
The recommended maximum daily dose should not be exceeded. In case of insufficient therapeutic effect, additional NSAIDs should also not be used, as this may increase toxicity, while the therapeutic benefit has not been proven. The simultaneous use of meloxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Meloxicam should not be used to treat patients who require relief of acute pain.
If there is no improvement after several days of use of the medicinal product, the clinical benefits of treatment should be re-evaluated.
Meloxicam cannot be a likely substitute for corticosteroids in the treatment of corticosteroid insufficiency.
Attention should be paid to a history of esophagitis, gastritis and/or peptic ulcer in order to ensure that they are completely cured before starting therapy with meloxicam. Regular attention should be paid to the possible manifestation of relapse in patients treated with meloxicam and patients with a history of such cases.
Meloxicam, like any other NSAID, may mask the symptoms of infectious diseases.
The pharmacological action of meloxicam to reduce fever and inflammation may complicate the diagnosis of suspected non-infectious pain conditions.
Effects on the digestive tract
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be started at the lowest effective dose. Combination therapy with protective agents (such as misoprostol or proton pump inhibitors) should be considered for such patients, as well as for patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that increase gastrointestinal risks (see information below and section "Interaction with other medicinal products and other forms of interaction").
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be informed of any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section "Adverse reactions").
The use of meloxicam is not recommended in patients taking concomitant medications that may increase the risk of ulceration or bleeding, including heparin as a radical therapy or in geriatric practice, anticoagulants such as warfarin or other NSAIDs, including acetylsalicylic acid at doses ≥ 500 mg per dose or ≥ 3 g total daily dose.
If gastrointestinal bleeding or ulceration occurs, the drug should be discontinued.
Effect on the liver
Up to 15% of patients taking NSAIDs (including meloxicam) may have elevations in one or more liver function tests. These laboratory abnormalities may progress, remain stable, or be transient with continued treatment. Marked elevations of ALT or AST (approximately 3 times the upper limit of normal) have been observed in 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fulminant hepatitis, hepatic necrosis, and hepatic failure, some of which were fatal, have been reported.
Patients with symptoms or suspected liver dysfunction or who have had abnormal liver tests should be evaluated for the development of symptoms of more severe liver failure during drug therapy. If clinical signs and symptoms are consistent with the development of liver disease or if systemic manifestations of the disease (e.g., eosinophilia, rash, etc.) are observed, the drug should be discontinued.
Effects on the cardiovascular system
Close monitoring is recommended in patients with hypertension and/or a history of mild to moderate congestive heart failure, as fluid retention and edema have been reported with NSAID therapy.
Clinical monitoring of blood pressure is recommended in patients with risk factors at the beginning of therapy, especially at the beginning of a course of meloxicam treatment.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with meloxicam only after careful consideration. Similar consideration is necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking).
Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a small increased risk of vascular thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for meloxicam.
Use of the drug Loxidol may increase the risk of serious cardiovascular thrombotic complications, myocardial infarction and stroke, which can be fatal. The increase in risk is associated with the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.
Effects on the skin
Patients should be informed of the signs and symptoms of severe skin reactions and should be closely monitored for skin reactions. If a patient develops symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (e.g., skin rash often progressing to blisters or mucosal lesions), treatment should be discontinued. It is important to promptly diagnose and discontinue any drugs that may cause severe skin reactions: Stevens-Johnson syndrome or toxic epidermal necrolysis. This is associated with a better prognosis for severe skin reactions. If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam, its use should not be resumed at any time in the future.
Cases of fixed drug eruption have been reported with the use of meloxicam.
Loxidol should not be re-administered to patients who have had a history of fixed drug eruption associated with the use of meloxicam.
Potential cross-reactivity may occur with other oxicams.
Anaphylactic reactions
As with other NSAIDs, anaphylactic reactions may occur in patients with no known reaction to meloxicam. The drug should not be used in patients with the aspirin triad. This symptom complex occurs in patients with asthma who have reported rhinitis with or without nasal polyps or who have experienced severe, potentially fatal bronchospasm after taking acetylsalicylic acid or other NSAIDs. Emergency care should be taken if an anaphylactoid reaction occurs.
Effects on liver and kidney function parameters
As with most NSAIDs, isolated cases of increased levels of transaminases and bilirubin in the blood plasma or other parameters of liver function, as well as increases in plasma creatinine and blood urea nitrogen, and other laboratory abnormalities have been described. In most cases, these abnormalities were minor and transient. If significant or persistent confirmation of such abnormalities occurs, the drug should be discontinued and control tests should be performed.
Effects on the kidneys
NSAIDs, by inhibiting the vasodilatory effects of renal prostaglandins, can induce functional renal failure due to decreased glomerular filtration. This side effect is dose-dependent.
In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome.
At the beginning of treatment or after increasing the dose, careful monitoring of diuresis and renal function is recommended for patients with the following risk factors: elderly age; concomitant use with ACE inhibitors, ARBs, sartans, diuretics; hypovolemia (of any origin); congestive heart failure; renal failure; nephrotic syndrome; lupus nephropathy; severe hepatic dysfunction (plasma albumin < 25 g/l or ≥ 10 g/l according to the Child-Pugh classification).
The dose of meloxicam for patients with end-stage renal disease on dialysis should not exceed 7.5 mg (use other dosage forms of meloxicam with appropriate dosage). For patients with mild to moderate renal failure (creatinine clearance greater than 25 ml/min), the dose may not be reduced.
Effect on water and electrolyte balance
NSAIDs may increase sodium, potassium and water retention and may interfere with the natriuretic effects of diuretics. In addition, the antihypertensive effect of antihypertensive drugs may be reduced. In this regard, edema, heart failure or hypertension may be precipitated or aggravated in susceptible patients. Therefore, clinical monitoring is recommended in patients at risk.
Hyperkalemia
Hyperkalemia may also develop, which may be caused by diabetes mellitus or concomitant use of drugs that increase potassium levels. In such cases, regular monitoring of potassium levels in the blood plasma is necessary.
Hematological reactions
Anemia may occur in patients receiving NSAIDs, including meloxicam. This may be due to fluid retention, gastrointestinal (latent or gross), or incompletely described effects on erythropoiesis. With long-term use of the drug, hemoglobin or hematocrit should be monitored if symptoms and signs of anemia are present.
NSAIDs inhibit platelet aggregation and may prolong bleeding time in some patients. In contrast to acetylsalicylic acid, their effect on platelet function is quantitatively smaller, short-lived and reversible. Meloxicam should be used with caution in patients who may have adverse effects related to changes in platelet function, in particular coagulation disorders, or in patients receiving anticoagulants.
Combination with pemetrexed
In patients with mild to moderate renal impairment receiving pemetrexed, meloxicam treatment should be suspended for at least 5 days prior to, on the day of, and for at least 2 days following pemetrexed administration (see section 4.5).
Adverse reactions are often worse tolerated by elderly, frail or debilitated patients who require close monitoring. As with other NSAIDs, Loxidol should be used with caution in elderly patients, who are more likely to have decreased renal, hepatic and cardiac function. Elderly patients have a higher incidence of adverse reactions to meloxicam, especially gastrointestinal bleeding and perforation, which can be fatal.
Patients with existing asthma
Patients with asthma may have aspirin-sensitive asthma. The use of acetylsalicylic acid (aspirin) in such patients has been associated with severe bronchospasm, which may be fatal. Because of cross-reactivity, including bronchospasm, between acetylsalicylic acid and other NSAIDs, the drug should not be used in patients sensitive to acetylsalicylic acid and should be used with caution in patients with pre-existing asthma.
Excipients
The drug Loxidol contains lactose, therefore it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
This medicine also contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
Impact on fertility
Meloxicam may have an adverse effect on reproductive function and is therefore not recommended in women attempting to conceive. Women planning pregnancy or undergoing investigation of infertility should consider discontinuing the medicinal product (see section "Use during pregnancy and lactation").
Use during pregnancy or breastfeeding
Pregnancy period
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal development. Epidemiological data suggest an increased risk of miscarriage and of cardiac malformations and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiac malformations has increased from less than 1% to approximately 1.5%. This risk is thought to increase with increasing dose and duration of treatment.
From the 20th week of pregnancy, the use of meloxicam may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment.
During the first and second trimesters of pregnancy, Loxidol should not be used unless clearly necessary. If a woman is trying to become pregnant or is using meloxicam during the first and second trimesters of pregnancy, the dosage and duration of treatment should be kept to a minimum.
Antenatal monitoring for oligohydramnios and ductus arteriosus should be considered after exposure to meloxicam for several days, starting from the 20th week of gestation. The drug should be discontinued if oligohydramnios or ductus arteriosus is detected.
In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose a risk to the fetus:
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction, which may develop into renal failure with oligohydramnios (see above);
possible risks in the last stages of pregnancy for the mother and newborn:
prolongation of bleeding time, antiaggregatory effect even at very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, the drug is contraindicated in the third trimester of pregnancy.
Breastfeeding period
Although there are no specific data for meloxicam, NSAIDs are known to pass into breast milk. Therefore, the use of the drug in women during breastfeeding is not recommended.
Fertility
Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may have a negative effect on reproductive function and is therefore not recommended in women attempting to conceive. For women planning pregnancy or undergoing investigation of infertility, discontinuation of the drug should be considered.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no specific studies on the effects of meloxicam on the ability to drive or use machines. However, based on the pharmacodynamic profile and the adverse reactions observed, it can be assumed that meloxicam has no or negligible influence on these activities. However, patients who have experienced visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other central nervous system disorders, are advised to refrain from driving or using machines.
Method of administration and doses
Dosage
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to treatment should be reassessed periodically.
Exacerbation of osteoarthritis:
7.5 mg per day (use other dosage forms of meloxicam with appropriate dosage). If necessary, the dose can be increased to 15 mg per day.
Rheumatoid arthritis, ankylosing spondylitis:
15 mg per day (1 tablet).
See also the section “Special patient categories” below.
According to the therapeutic effect, the dose can be reduced to 7.5 mg per day (use other dosage forms of meloxicam with the appropriate dosage).
DO NOT EXCEED THE DOSE OF 15 mg per day.
Special categories of patients
Elderly patients
The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day (use other dosage forms of meloxicam with appropriate dosage) (see also sections “Method of administration and dosage”, “Patients at increased risk of developing adverse reactions” and section “Special instructions for use”).
Patients at increased risk of adverse reactions (see section "Special warnings and precautions for use")
Patients with an increased risk of adverse reactions, such as those with a history of gastrointestinal diseases or risk factors for cardiovascular disease, should start treatment with a dose of 7.5 mg per day (use other dosage forms of meloxicam with appropriate dosage).
Kidney failure
This medicinal product is contraindicated in patients with severe renal impairment not undergoing haemodialysis (see section “Contraindications”).
For patients with end-stage renal disease on hemodialysis, the dose should not exceed 7.5 mg per day (use other dosage forms of meloxicam with appropriate dosage). For patients with mild to moderate renal impairment (i.e. patients with creatinine clearance above 25 ml/min), no dose reduction is required.
Liver failure
No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment, see section "Contraindications").
Method of application
For oral use.
The drug Loxidol, 15 mg tablets, should be taken with water or other liquid, during meals.
Children.
The drug Loxidol, 15 mg tablets, is contraindicated in children under 16 years of age (see the "Contraindications" section).
Overdose
Symptoms
Symptoms of acute NSAID overdose are usually limited to drowsiness, lethargy, nausea, vomiting and epigastric pain, which are generally reversible with supportive therapy. Gastrointestinal bleeding may occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular failure and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic use of NSAIDs and may also occur with overdose.
Treatment
In case of overdose, symptomatic and supportive therapy should be administered. Studies have shown that the elimination of meloxicam is accelerated by administration of 4 g of cholestyramine 3 times a day.
Side effects
Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment) may be associated with a small increased risk of vascular thrombotic events, such as myocardial infarction or stroke (see section "Special warnings and precautions for use").
Edema, hypertension, and heart failure have been observed with NSAID treatment.
Most of the adverse reactions observed are of gastrointestinal origin. Peptic ulceration, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients (see section "Special instructions"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section "Special instructions"). Gastritis has been observed less frequently after administration.
Severe skin reactions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis (see section "Special warnings and precautions for use").
Criteria for assessing the frequency of adverse reactions: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (<1/10000); frequency unknown
