Meloxicam Teva solution for injection 15 mg/1.5 ml in 1.5 ml ampoules 5 pcs.

Pharmacodynamics. Meloxicam-ratiopharm is an NSAID of the oxicam group with anti-inflammatory, analgesic and antipyretic properties, which are associated with selective inhibition of the COX-2 isoenzyme. The selectivity coefficient ic50 for meloxicam is 2.

Pharmacokinetics

Absorption: Meloxicam is almost completely absorbed from the gastrointestinal tract. Absolute bioavailability after oral administration is 89%. After a single oral dose, peak plasma levels are reached after 5-6 hours (tablets). After repeated administration, steady state is reached after 3-5 days from the start of meloxicam administration.

When taking 7.5 or 15 mg of meloxicam orally once a day in a stationary mode, the concentration in the blood plasma reaches 0.4-1.0 mg/l (7.5 mg) or 0.8-2.0 mg/l (15 mg) (C _min -C _max).

In case of long-term treatment, the plasma concentration under steady-state conditions does not change. Gastric absorption is not changed in case of simultaneous food intake.

Distribution: Meloxicam is highly bound to blood proteins, mainly albumin (99%). Meloxicam enters the synovial fluid, where its concentration is ½ of that in blood plasma.

The volume of distribution averages 11 L. Individual fluctuations are about 30-40%.

Biological transformation: Meloxicam is metabolized by liver enzymes. Four different pharmacologically inactive metabolites of meloxicam have been identified in the urine. The main metabolite, 5′-carboxymeloxicam (60%) is formed by oxidation of the intermediate metabolite 5′-hydroxymethylmeloxicam. The amount of 5′-hydroxymethylmeloxicam excreted unchanged is 9%. In vitro, it has been established that the initial stage of this transformation is carried out mainly by CYP 2C9 with a minor contribution from CYP 3A4. The formation of two other metabolites (respectively 16 and 4% of the dose) is associated with the action of peroxidase.

Elimination: Meloxicam is excreted mainly in the form of metabolites, in equal parts with urine and feces. Meloxicam is detected in urine in insignificant (trace) quantities. The average T½ _is about 20 hours. The total plasma clearance is on average 8 ml/min.

Linearity: When administered orally at therapeutic doses (7.5 and 15 mg), meloxicam exhibits linear pharmacokinetics.

Special patient groups

Hepatic/renal insufficiency. Neither mild nor moderate hepatic or renal insufficiency significantly affects the pharmacokinetics of meloxicam. In end-stage renal failure, an increase in the volume of distribution may lead to high concentrations of free meloxicam, so a daily dose of 7.5 mg should not be exceeded.

Elderly patients: The mean clearance value in the plateau phase in elderly patients was slightly lower than that reported in young patients.

Tablets. Short-term symptomatic treatment of exacerbations of osteoarthritis. Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.

R-r. Short-term symptomatic treatment of acute attacks of rheumatoid arthritis and ankylosing spondylitis, when oral and rectal routes of administration cannot be used.

Tablets. are administered orally. The total daily dose should be taken once, with a glass of water or other liquid, during meals.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see Precautions). The patient’s need for symptomatic treatment and response to treatment should be assessed periodically.

Exacerbation of osteoarthritis: 7.5 mg/day (1 tablet of 7.5 mg or half a tablet of 15 mg). If necessary, the dose can be increased to 15 mg/day (1 tablet of 15 mg or 2 tablets of 7.5 mg).

Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (1 tablet of 15 mg or 2 tablets of 7.5 mg). Depending on the therapeutic effect, the dose can be reduced to 7.5 mg/day (1 tablet of 7.5 mg or half a tablet of 15 mg).

The daily dose of meloxicam should not exceed 15 mg.

Solution for injection. Meloxicam should be administered by intramuscular injection.

One injection of 15 mg once daily.

Do not exceed the dose of 15 mg/day.

Treatment should be limited to a single injection at the beginning of therapy with a maximum duration of up to 2-3 days in justified exceptional cases (e.g. when oral and rectal routes of administration are not possible). Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see Precautions).

The patient’s need for symptomatic treatment and response to treatment should be assessed periodically.

Special patient groups

Elderly patients and patients at increased risk of adverse reactions. The recommended dose for elderly patients is 7.5 mg/day. Patients at increased risk of adverse reactions should start treatment with 7.5 mg/day (half a 1.5 ml ampoule) (see Precautions).

Renal failure: In patients with severe renal failure on dialysis, the dose should not exceed 7.5 mg/day (half a 1.5 ml ampoule).

No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with creatinine clearance <25 ml/min). For patients with severe renal impairment not requiring dialysis, see Adverse Reactions.

Hepatic impairment: No dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, see Adverse Reactions section.

Method of administration. The drug should be administered slowly, by deep intramuscular injection into the upper outer quadrant of the buttock, observing strict aseptic technique. In case of repeated administration, it is recommended to change the injection site (alternating the left and right buttock). Before injection, it is important to check that the needle tip is not in a vessel.

The injection should be stopped immediately if there is severe pain during the injection.

In the case of a hip prosthesis, the injection should be given in the other buttock.

Hypersensitivity to meloxicam or other components of the drug or to drugs with a similar effect, such as other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid. Contraindicated in patients who have experienced symptoms of BA, nasal polyps, angioedema or urticaria after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; 3rd trimester of pregnancy(See Use during pregnancy and breastfeeding);

patient’s age up to 18 years (for solution), up to 16 years – for tablets;

history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;

history of active or recurrent ulcer/bleeding (two or more separate confirmed cases of ulceration or bleeding);

severe liver failure;

severe renal failure without dialysis;

gastrointestinal bleeding, history of cerebrovascular bleeding, or other blood clotting disorders;

impaired hemostasis or simultaneous use of anticoagulants (contraindications related to the route of administration);

severe heart failure;

Treatment of perioperative pain in coronary artery bypass grafting.

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 (e.g. myocardial infarction or stroke) (see Special instructions).

Edema, hypertension, and heart failure have been observed with NSAID treatment.

Most of the side effects occurred from the gastrointestinal tract. Ulceration, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see Special warnings and precautions for use). After use, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease were observed (see Special warnings and precautions for use). Gastritis was observed less frequently.

Blood and lymphatic system disorders: Anemia, abnormal blood count (including changes in leukocyte count), leukopenia, thrombocytopenia. Very rare cases of agranulocytosis have been reported (see Description of selected serious and/or common adverse reactions).

Immune system disorders: allergic reactions, including anaphylactic shock, anaphylactoid reactions, anaphylactic reactions.

Mental disorders: confusion, mood swings, nightmares, insomnia, disorientation.

From the nervous system: dizziness, headache, drowsiness.

On the part of the organ of vision: visual impairment, including blurred vision, conjunctivitis.

From the side of the organs of hearing and vestibular apparatus: dizziness, ringing in the ears.

Cardiac: palpitations, heart failure.

From the vascular system: increased blood pressure, hot flashes.

Respiratory system: patients with a history of allergic reactions to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs may experience asthma attacks, upper respiratory tract infections, and cough.

Gastrointestinal: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, occult or macroscopic gastrointestinal bleeding, gastroduodenal ulcer, esophagitis, stomatitis, constipation, flatulence, belching, gastrointestinal perforation, gastritis, colitis. Ulcer disease, perforation or gastrointestinal bleeding may be severe and potentially fatal, especially in elderly patients.

Hepatobiliary system: abnormal liver function tests (e.g. increased transaminases or bilirubin), hepatitis, jaundice, liver failure.

Skin and subcutaneous tissue disorders: pruritus, rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, bullous dermatitis, erythema multiforme, photosensitivity, exfoliative dermatitis.

From the urinary system: sodium and water retention, hyperkalemia, impaired renal function (increased creatinine and/or urea levels in blood plasma), acute renal failure, particularly in patients at high risk, urinary tract infections, urination disorders, including acute urinary retention.

Musculoskeletal: arthralgia, back pain, joint-related signs and symptoms.

General disorders and administration site conditions: injection site induration, injection site pain; swelling, including swelling of the lower extremities, flu-like symptoms.

Description of selected serious and/or common adverse reactions: Cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic drugs (see Interactions with other drugs).

Adverse reactions that have not previously been observed with this drug, but are characteristic of other drugs of this pharmacotherapeutic group. Renal dysfunction up to renal failure: cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see Uses and information on gastrointestinal and cardiovascular risks below).

The recommended maximum daily dose may be exceeded in case of insufficient therapeutic effect, and additional NSAIDs should not be used, as this may increase toxicity, while the therapeutic benefit has not been proven. The concomitant use of meloxicam with NSAIDs, including selective COX-2 inhibitors, should be avoided.

Meloxicam is not used to treat patients requiring relief of acute pain.

If there is no improvement after several days, the clinical benefits of treatment should be reassessed.

Attention should be paid to a history of esophagitis, gastritis and/or ulcer in order to ensure that they have fully resolved before starting therapy with meloxicam. Patients treated with meloxicam and patients with a history of such cases should be regularly monitored for possible recurrence.

Gastrointestinal disorders: As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment with or without previous symptoms or a history of serious gastrointestinal disease.

The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated by bleeding or perforation (see Adverse Reactions), and in elderly patients. These patients should be started on the lowest effective dose. Combination therapy with protective agents (such as misoprostol or proton pump inhibitors) should be considered for these patients, as well as for patients who require concomitant low-dose aspirin or other drugs that increase gastrointestinal risks (see information below and section Interactions).

Patients with a history of gastrointestinal toxicity, especially elderly patients, should be advised to report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.

Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, in particular heparin, as radical therapy or in geriatric practice, anticoagulants such as warfarin or other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid at anti-inflammatory doses (≥1 g single dose or ≥3 g total daily dose) (see Interactions with other medicinal products).

If gastrointestinal bleeding or ulceration occurs in patients taking meloxicam, treatment should be discontinued.

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 Side Effects).

Hepatic: In patients taking NSAIDs (including meloxicam), elevations of one or more liver function tests may occur. These laboratory abnormalities may progress, remain stable, or be transient with continued treatment. Elevations of ALT or AST (approximately 3 or more times the upper limit of normal) may occur. Isolated 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 and/or signs of hepatic dysfunction or who have had abnormal liver function tests should be evaluated for the development of symptoms of more severe hepatic insufficiency during meloxicam therapy. If clinical signs and symptoms are associated with the development of liver disease or if systemic manifestations of the disease (e.g. eosinophilia, rash, etc.) are observed, then meloxicam should be discontinued.

Cardiovascular disorders: Close observation 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 treatment with meloxicam.

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.

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. Such consideration is necessary at the beginning of long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes mellitus, smoking).

NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which may be fatal. The increased risk is related to the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.

Skin. Serious skin reactions, some of which were fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with NSAIDs (see Adverse Reactions). The risk of such reactions is highest at the beginning of treatment, with most occurring within the first month of treatment. Meloxicam should be discontinued at the first appearance of skin rash, mucosal lesions or other signs of hypersensitivity.

Anaphylactic reactions. As with other NSAIDs, anaphylactic reactions may occur in patients with no known history of reaction to meloxicam. The drug should not be used in patients with the aspirin triad. This symptom complex has been observed in patients with asthma who have reported rhinitis with or without nasal polyps or who have experienced severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency care should be sought if an anaphylactoid reaction occurs.

Liver and kidney function: As with most NSAIDs, isolated cases of increased plasma transaminases, plasma bilirubin or other liver function tests, as well as increases in plasma creatinine, blood urea nitrogen and other laboratory abnormalities have been reported. In most cases, these abnormalities were minor and transient. If significant or persistent abnormalities occur, meloxicam should be discontinued and follow-up tests should be performed.

Functional renal failure. NSAIDs, by inhibiting the vasodilatory effects of renal prostaglandins, may induce functional renal failure due to a decrease in glomerular filtration. This side effect is dose-dependent. At the beginning of treatment or after increasing the dose, careful monitoring of diuresis and renal function is recommended in patients with the following risk factors:

advanced age;

simultaneous use with ACE inhibitors, angiotensin II antagonists, sartans, diuretics (see Interaction with other drugs);

hypovolemia (of any origin);

congestive heart failure;

renal failure;

nephrotic syndrome;

lupus nephropathy;

severe hepatic dysfunction (plasma albumin <25 g/l or ≥10 according to the Child-Pugh classification).

In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome.

The dose of meloxicam for patients with end-stage renal disease on dialysis should not exceed 7.5 mg. In patients with mild to moderate renal impairment, the dose may not be reduced (creatinine clearance 25 ml/min).

Sodium, potassium and water retention. NSAIDs may increase sodium, potassium and water retention and affect the natriuretic effect of diuretics. In addition, a decrease in the antihypertensive effect of antihypertensive drugs may be observed (see Interaction with other drugs). In this regard, edema, heart failure or hypertension may accelerate or worsen in susceptible patients. Therefore, clinical monitoring is recommended in patients at such risk (see Method of administration and contraindications).

Hyperkalemia: Hyperkalemia may be caused by diabetes mellitus or concomitant use of drugs that increase potassium levels (see Interactions with other drugs). In such cases, potassium levels should be monitored regularly.

Warnings and precautions. Adverse reactions are often worse tolerated by elderly, frail or debilitated patients who require close supervision. As with other NSAIDs, caution should be exercised in the elderly, who are more likely to have decreased renal, hepatic and cardiac function. Elderly patients have a higher incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see Dosage & Administration).

Meloxicam, like any other NSAID, may mask the symptoms of infectious diseases.

The use of meloxicam may adversely affect reproductive function and is not recommended in women attempting to conceive. Therefore, for women attempting to conceive or undergoing investigation of infertility, discontinuation of meloxicam should be considered (see Use during pregnancy and lactation).

Masking of inflammation and fever. The pharmacological action of meloxicam to reduce fever and inflammation may complicate the diagnosis of suspected non-infectious pain syndrome.

Corticosteroid treatment. Meloxicam cannot be a likely substitute for corticosteroids in the treatment of glucocorticosteroid insufficiency.

Hematological effects. Anemia may occur in patients receiving NSAIDs, including meloxicam. This may be due to fluid retention, gastrointestinal bleeding of unknown origin, or macroscopic or incompletely described effects on erythropoiesis. Patients receiving long-term treatment with NSAIDs, including meloxicam, should have their hemoglobin or hematocrit monitored if they have symptoms and signs of anemia.

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. Patients taking meloxicam who may have adverse effects related to changes in platelet function, in particular coagulation disorders, or patients receiving anticoagulants should be carefully monitored.

Use in patients with existing asthma. Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Given the cross-reactivity, including bronchospasm, between acetylsalicylic acid and other NSAIDs, meloxicam should not be used in patients sensitive to acetylsalicylic acid and should be prescribed with caution in patients with existing asthma.

Other: As with other injectable NSAIDs, abscess and necrosis may develop at the injection site.

The drug contains a very small amount of sodium, i.e. it is virtually sodium-free.

Use during pregnancy and lactation. Pregnancy. 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 about 1.5%. This risk is believed to increase with increasing dose and duration of treatment.

In the first and second trimesters of pregnancy, meloxicam should not be used unless clearly necessary. If a woman is planning a pregnancy or is using meloxicam during the first and second trimesters of pregnancy, the dosage and duration of treatment should be kept to a minimum.

In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose a risk to the fetus:

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

renal dysfunction, which may develop into renal failure with oligohydramnios;

possible risks in the last stages of pregnancy for the mother and newborn:

risk of prolonged bleeding time, antiplatelet effect even at very low doses;

suppression of uterine contractions, leading to delayed or prolonged labor.

Therefore, meloxicam is contraindicated in the third trimester of pregnancy.

Breastfeeding: Although there are no specific data for meloxicam, NSAIDs are known to pass into breast milk. Therefore, use is not recommended in women who are breastfeeding.

Fertility: Meloxicam, like other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may have an adverse effect on reproductive function and is not recommended in women attempting to conceive. Therefore, in women attempting to conceive or undergoing investigation of infertility, discontinuation of meloxicam should be considered.

Children. The drug in the form of a solution for injection is contraindicated in children under 18 years of age; in the form of tablets of 7.5 mg and 15 mg – is contraindicated in children under 16 years of age.

Ability to influence the reaction rate when driving vehicles or working with other mechanisms. There are no special studies of the effect of the drug on the ability to drive vehicles or work with complex mechanisms. However, based on the pharmacodynamic profile and the adverse reactions that have occurred, it can be assumed that meloxicam is likely to have no or negligible influence on the specified activity. However, patients who have experienced visual impairment, including blurred vision, dizziness, drowsiness, vertigo or other disorders from the central nervous system, are recommended to refrain from driving vehicles or working with mechanisms.

pharmacodynamic interactions

Other NSAIDs and acetylsalicylic acid ≥3 g/dose. Combination with other NSAIDs is not recommended (see Precautions), including acetylsalicylic acid at anti-inflammatory doses (≥1 g single dose or ≥3 g total daily dose).

Corticosteroids (e.g. glucocorticoids). Concomitant use with corticosteroids requires caution due to an increased risk of bleeding or ulceration in the gastrointestinal tract.

Anticoagulants or heparin used in geriatric practice or at therapeutic doses. 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 Precautions). The concomitant use of NSAIDs and anticoagulants or heparin in geriatric practice or at therapeutic doses is not recommended (see Precautions).

In other cases, heparin should be used with caution due to the increased risk of bleeding. Careful monitoring of the INR (international normalized ratio) 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 COX may lead to further deterioration of renal function, including possible AKI, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be monitored after initiation of combination therapy and periodically thereafter (see Precautions).

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 prostaglandins with vasodilatory effect).

Calcineurin inhibitors (e.g. cyclosporine, tacrolimus). The nephrotoxicity of calcineurin inhibitors may be potentiated by NSAIDs due to mediation of the effects of renal prostaglandins. Renal function should be monitored during treatment. Close monitoring of renal function is recommended, especially in elderly patients.

Intrauterine contraceptive devices. NSAIDs reduce the effectiveness of intrauterine contraceptive devices. It has been previously reported that the effectiveness of intrauterine contraceptive devices is reduced by NSAIDs, but this requires further confirmation.

Pharmacokinetic interaction: effect of meloxicam on the pharmacokinetics of other drugs

Lithium. There are reports of NSAIDs increasing plasma lithium concentrations (due to decreased renal lithium excretion), which may reach toxic levels. Concomitant use of lithium and NSAIDs is not recommended (see Precautions). If combination therapy is necessary, careful monitoring of plasma lithium levels is recommended at the start of treatment, during dose adjustment and upon discontinuation of meloxicam.

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 Precautions). The risk of interaction between NSAIDs and methotrexate should also be considered in patients receiving low doses of methotrexate, particularly in patients with impaired renal function. If combined treatment is necessary, blood counts and renal function should be monitored. Caution should be exercised if NSAIDs and methotrexate are administered for 3 consecutive days, as plasma levels of methotrexate may increase and toxicity may be increased. Although the pharmacokinetics of methotrexate (15 mg/week) were not affected by concomitant treatment with meloxicam, it should be considered that the hematological toxicity of methotrexate may be increased by treatment with NSAIDs (see Information above) (see Adverse Reactions).

Pharmacokinetic interaction: effect of other drugs on the pharmacokinetics of meloxicam

Cholestyramine. Accelerates the elimination of meloxicam due to impaired intrahepatic circulation, so the clearance of meloxicam increases by 50% and T _½ decreases to 13 ± 3 hours. This interaction is clinically significant.

No clinically significant pharmacokinetic interaction was found when co-administered with antacids, cimetidine, and digoxin.

Incompatibility. The solution for injection must not be mixed with other drugs in the same syringe.

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and stomach pain, which are usually reversible with symptomatic therapy. Gastrointestinal bleeding may also occur. Severe poisoning can lead to increased blood pressure, development of acute renal failure, impaired liver function, respiratory depression, coma, convulsions, collapse and cardiac arrest.

Anaphylactoid reactions have been reported with therapeutic doses of nonsteroidal anti-inflammatory drugs in case of overdose.

After an NSAID overdose, patients are given supportive and symptomatic therapy according to the severity of the overdose and intoxication. Clinical studies have shown that taking 4 g of cholestyramine orally 3 times a day accelerates the elimination of meloxicam.

At a temperature not exceeding 25 °C.