Meloxicam tablets 15mg, No. 20

• Symptomatic treatment of osteoarthritis;

• symptomatic treatment of rheumatoid arthritis, symptomatic treatment of ankylosing spondylitis (ankylosing spondylitis).

The drug is taken orally with meals once a day. Recommended dosage regimen: - Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day. - Osteoarthritis: 7.5 mg per day. If ineffective, the dose can be increased to 15 mg per day. - Ankylosing spondylitis: 15 mg per day. The maximum daily dose should not exceed 15 mg. In patients with an increased risk of side effects, as well as in patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg per day.

Tablets 1 tab.

meloxicam 15 mg

• Hypersensitivity (including to other NSAIDs),

• contraindicated in the period after coronary artery bypass grafting,

• decompensated heart failure,

• complete or incomplete combination of bronchial asthma,

• recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs,

• peptic ulcer of the stomach and duodenum in the acute stage;

• gastrointestinal,

• cerebrovascular or other bleeding / hemorrhage,

• severe liver failure

• severe renal failure (unless hemodialysis is performed),

• pregnancy,

• lactation,

• age up to 15 years.

pharmachologic effect

Meloxicam is a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic effects. The anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the area of ??inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.

Side effect

From the hematopoietic system: infrequently - anemia; rarely - leukopenia, thrombocytopenia, changes in the number of blood cells, including changes in the leukocyte formula.

From the immune system: infrequently - other immediate-type hypersensitivity reactions; not established - anaphylactic shock, anaphylactoid reactions.

Mental disorders: rarely - mood changes; not established - confusion of consciousness, disorientation.

From the side of the nervous system: often - headache; infrequently - dizziness, drowsiness.

From the side of the senses: infrequently - vertigo; rarely - conjunctivitis, visual impairment, including blurred vision, tinnitus.

From the side of the cardiovascular system: infrequently - an increase in blood pressure, a feeling of 'rush' of blood to the face; rarely - palpitations.

On the part of the respiratory system: rarely - bronchial asthma in patients with allergies to acetylsalicylic acid and other NSAIDs.

From the digestive system: often - abdominal pain, dyspepsia, diarrhea, nausea, vomiting; infrequently - latent or overt gastrointestinal bleeding, gastritis, stomatitis, constipation, bloating, belching; rarely - gastroduodenal ulcers, colitis, esophagitis; very rarely - perforation of the gastrointestinal tract.

From the liver and biliary tract: infrequently - transient changes in liver function indicators (for example, an increase in transaminase activity or bilirubin concentration); very rarely - hepatitis.

From the side of the skin and subcutaneous tissues: infrequently - angioedema, itching, skin rash; rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria; very rarely - bullous dermatitis, erythema multiforme; frequency not established - photosensitivity.

From the urinary system: infrequently - changes in renal function indicators (increased concentration of creatinine and / or urea in the blood serum), urinary disorders, including acute urinary retention; very rarely - acute renal failure.

On the part of the genitals and mammary gland: infrequently - late ovulation; not established - infertility in women.

General disorders and disorders at the injection site: often - pain and swelling at the injection site; infrequently - edema.

Concomitant use with drugs that depress the bone marrow (for example, methotrexate) can provoke cytopenia.

Gastrointestinal bleeding, ulceration, or perforation can be fatal.

As with other NSAIDs, the possibility of the appearance of interstitial nephritis, glomerulonephritis, renal medullary necrosis, and nephrotic syndrome is not excluded.

Use in elderly patients

It should be used with caution in elderly patients.

special instructions

Patients with gastrointestinal diseases require regular monitoring. In the event of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, meloxicam should be canceled.

Gastrointestinal ulcers, perforation, or bleeding can occur with NSAIDs at any time, with or without a history of alarming symptoms or a history of serious gastrointestinal complications. The consequences of these complications are generally more serious for the elderly.

With the use of meloxicam, such serious skin reactions as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis can develop. Therefore, special attention should be paid to patients reporting the development of adverse events from the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during previous courses of treatment. The development of such reactions is observed, as a rule, during the first month of treatment. In the event of the first signs of a skin rash, changes in mucous membranes or other signs of hypersensitivity, consideration should be given to discontinuing the use of meloxicam.

There are cases when taking NSAIDs to increase the risk of developing serious cardiovascular thrombosis, myocardial infarction, angina pectoris attack, possibly fatal. This risk increases with prolonged use of the drug, as well as in patients with a history of the above diseases and those predisposed to such diseases.

NSAIDs inhibit the synthesis of prostaglandins in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced BCC can lead to decompensation of latent renal failure. After the withdrawal of NSAIDs, renal function is usually restored to its original level. The most at risk of developing this reaction are elderly patients, patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome or acute renal dysfunction, patients taking diuretics, ACE inhibitors, angiotensin II receptor antagonists, and also patients who have undergone major surgical interventions that lead to hypovolemia.In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy.

The use of NSAIDs in conjunction with diuretics can lead to sodium, potassium and water retention, as well as to a decrease in the natriuretic effect of diuretics. As a result, predisposed patients may experience increased signs of heart failure or arterial hypertension. Therefore, careful monitoring of the condition of such patients is necessary, as well as the maintenance of adequate hydration.

Before starting treatment, a study of renal function is necessary. In the case of combination therapy, renal function should also be monitored.

When using meloxicam (as well as most other NSAIDs), an episodic increase in serum transaminase activity or other indicators of liver function is possible. In most cases, this increase was small and transient. If the identified changes are significant or do not decrease over time, meloxicam should be canceled, and the identified laboratory changes should be monitored.

Weakened or emaciated patients may be less tolerant of adverse events, and therefore, such patients should be carefully monitored.

Like other NSAIDs, meloxicam can mask the symptoms of an underlying infectious disease.

As an inhibitor of COX / prostaglandin synthesis, meloxicam may interfere with fertility and is therefore not recommended for women who have difficulty conceiving. In women undergoing examination for this reason, it is recommended to cancel meloxicam.

In patients with mild and moderate renal insufficiency (CC> 25 ml / min), dose adjustment is not required.

No dose adjustment is required in patients with (compensated) cirrhosis of the liver.

Influence on the ability to drive vehicles mechanisms

When driving and working with mechanisms, the possibility of dizziness, drowsiness, visual impairment or other disorders of the central nervous system should be taken into account. During the period of treatment, patients must be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Other inhibitors of prostaglandin synthesis, including glucocorticoids and salicylates - concomitant use with meloxicam increases the risk of gastrointestinal ulcers and gastrointestinal bleeding (due to synergistic action). Concomitant use with other NSAIDs is not recommended.

Anticoagulants for oral administration, heparin for systemic use, thrombolytic agents - simultaneous administration with meloxicam increases the risk of bleeding. In the case of simultaneous use, careful monitoring of the blood coagulation system is necessary.

Antiplatelet drugs, serotonin reuptake inhibitors - simultaneous administration with meloxicam increases the risk of bleeding due to inhibition of platelet function. In the case of simultaneous use, careful monitoring of the blood coagulation system is necessary.

Lithium preparations - NSAIDs increase the plasma level of lithium by decreasing its excretion by the kidneys. The simultaneous use of meloxicam with lithium preparations is not recommended. If necessary, simultaneous use is recommended to carefully monitor the concentration of lithium in the plasma during the entire course of lithium preparations.

Methotrexate - NSAIDs reduce the secretion of methotrexate by the kidneys, thereby increasing its concentration in plasma. The simultaneous use of meloxicam and methotrexate (at a dose of more than 15 mg per week) is not recommended. In the case of simultaneous use, careful monitoring of renal function and blood counts is necessary. Meloxicam may increase the hematological toxicity of methotrexate, especially in patients with impaired renal function.

Diuretics - the use of NSAIDs while taking diuretics in case of dehydration of patients is accompanied by the risk of developing acute renal failure.

Antihypertensive drugs (beta-blockers, ACE inhibitors, vasodilators, diuretics). NSAIDs reduce the effect of antihypertensive drugs by inhibiting prostaglandins, which have vasodilating properties.

Angiotensin II receptor antagonists, as well as ACE inhibitors, when used together with NSAIDs, increase the decrease in glomerular filtration, which, thereby, can lead to the development of acute renal failure, especially in patients with impaired renal function.

Cholestyramine, binding meloxicam in the gastrointestinal tract, leads to its faster excretion.

Pemetrexed - with the simultaneous use of meloxicam and pemetrexed in patients with CC from 45 to 79 ml / min, meloxicam should be discontinued 5 days before starting pemetrexed and may be resumed 2 days after the end of the intake. If there is a need for the combined use of meloxicam and pemetrexed, then patients should be carefully monitored, especially with regard to myelosuppression and the occurrence of side effects from the gastrointestinal tract. In patients with CC <45 ml / min, the use of meloxicam in conjunction with pemetrexed is not recommended.

NSAIDs, acting on renal prostaglandins, can increase the nephrotoxicity of cyclosporine.

With the simultaneous use of drugs with meloxicam that have a known ability to inhibit CYP2C9 and / or CYP3A4 (or are metabolized with the participation of these enzymes), such as sulfonylurea derivatives or probenecid, the possibility of pharmacokinetic interaction should be taken into account.

When used together with hypoglycemic agents for oral administration (for example, sulfonylurea derivatives, nateglinide), an interaction mediated by CYP2C9 is possible, which can lead to an increase in the concentration of both hypoglycemic agents and meloxicam in the blood. Patients who are simultaneously taking meloxicam with sulfonylureas or nateglinide should carefully monitor the blood glucose concentration due to the possibility of hypoglycemia.