Meloxicam - Teva tablets 15mg, No. 20

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Expiration Date: 05/2027

Russian Pharmacy name:

Мелоксикам - Тева таблетки 15мг, №20

Meloxicam - Teva tablets 15mg, No. 20

Symptomatic treatment:

  • osteoarthritis (arthrosis, degenerative diseases of the joints), including with a pain component;

  • rheumatoid arthritis;

  • ankylosing spondylitis;

  • other inflammatory and degenerative diseases of the musculoskeletal system, such as arthropathies, dorsopathies (for example, sciatica, lower back pain, shoulder periarthritis, and others), accompanied by pain.

Osteoarthritis with pain: 7.5 mg per day. If necessary, this dose can be increased to 15 mg per day.

Rheumatoid arthritis: 15 mg daily. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg per day.

Ankylosing spondylitis: 15 mg daily. Depending on the therapeutic effect, this dose can be reduced to 7.5 mg per day.

In patients with an increased risk of adverse reactions (history of gastrointestinal tract disease, presence of risk factors for cardiovascular diseases), it is recommended to start treatment with a dose of 7.5 mg per day (see Special Instructions).

In patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg per day.

General recommendations

Since the potential risk of adverse reactions depends on the dose and duration of treatment, the lowest possible dose and duration of use should be used.

The maximum recommended daily dose is 15 mg.

Combined use

The drug should not be used concomitantly with other NSAIDs.

The total daily dose of Meloxicam-Teva used in different dosage forms should not exceed 15 mg.

Teenagers

The maximum dose for adolescents (12 - 18 years old) is 0.25 mg / kg and should not exceed 15 mg.

The use of tablets

The drug is contraindicated in children under 12 years of age due to the impossibility of selecting the appropriate dosage for this age group.

The total daily dose should be taken at one time, with meals, with water or other liquid.

The tablets are round, flat-cylindrical, yellow in color, with a bevel and slight marbling; with dividing line on one side and engraved 'MLX 7.5' on the other.

1 tab. meloxicam 7.5 mg

Excipients: lactose monohydrate - 77.2 mg, microcrystalline cellulose - 56 mg, sodium citrate dihydrate - 18 mg, povidone K30 - 6 mg, crospovidone - 12 mg, colloidal silicon dioxide - 1.5 mg, magnesium stearate - 1.8 mg.

Oval tablets, yellow with slight marbling; with dividing line on one side and engraved 'MLX 15' on the other.

1 tab.

meloxicam 15 mg

Excipients: lactose monohydrate - 69.7 mg, microcrystalline cellulose - 56 mg, sodium citrate dihydrate - 18 mg, povidone K30 - 6 mg, crospovidone - 12 mg, colloidal silicon dioxide - 1.5 mg, magnesium stearate - 1.8 mg.

  • Hypersensitivity to the active ingredient or auxiliary components of the drug.

  • Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, angioedema or urticaria caused by intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs due to the existing likelihood of cross-sensitivity (including a history).

  • Erosive and ulcerative lesions of the stomach and duodenum in the acute stage or recently transferred.

  • Inflammatory bowel disease - Crohn's disease or ulcerative colitis in the acute stage.

  • Severe liver failure.

  • Severe renal failure (if hemodialysis is not performed, creatinine clearance is less than 30 ml / min, as well as with confirmed hyperkalemia), progressive kidney disease.

  • Active gastrointestinal bleeding, recent cerebrovascular bleeding or an established diagnosis of diseases of the blood coagulation system.

  • Severe uncontrolled heart failure.

  • Pregnancy.

  • Breast-feeding.

  • Therapy of perioperative pain during coronary artery bypass grafting.

  • Children under 12 years of age.

  • Rare hereditary galactose intolerance (in the maximum daily dose of the drug with a dosage of 7.5 mg and 15 mg meloxicam, 47 mg and 20 mg of lactose are contained, respectively).

  • With care: Ischemic heart disease; cerebrovascular diseases; chronic heart failure; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease, smoking, renal failure (creatinine clearance 30-60 ml / min); anamnestic data on the development of ulcerative lesions of the gastrointestinal tract; presence of Helicobacter pylori infection; elderly age; long-term use of NSAIDs; frequent alcohol consumption, severe somatic diseases; concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticoids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, serlin).

pharmachologic effect

NSAIDs, a derivative of enolic acid, have anti-inflammatory, analgesic and antipyretic effects. The mechanism of the anti-inflammatory action of meloxicam is its ability to inhibit the synthesis of prostaglandins, known mediators of inflammation. Meloxicam in vivo inhibits the synthesis of prostaglandins at the site of inflammation to a greater extent than in the gastric mucosa or kidneys. These differences are associated with a more selective inhibition of COX-2 compared to COX-1. Inhibition of COX-2 is believed to mediate the therapeutic effects of NSAIDs, while inhibition of the persistent isoenzyme COX-1 may be responsible for gastric and renal side effects.

The selectivity of meloxicam in relation to COX-2 has been confirmed in various test systems, both in vitro and in vivo. The selective ability of meloxicam to inhibit COX-2 has been shown when using human whole blood in vitro as a test system. It was found that meloxicam (at doses of 7.5 mg and 15 mg) inhibited COX-2 more actively, exerting a greater inhibitory effect on the production of prostaglandin E2 stimulated by lipopolysaccharide (a reaction controlled by COX-2) than on the production of thromboxane involved in blood coagulation ( reaction controlled by COX-1). These effects were dose dependent.

Ex vivo studies have shown that meloxicam (at doses of 7.5 mg and 15 mg) has no effect on platelet aggregation and bleeding time. In clinical studies, side effects from the gastrointestinal tract in general occurred less frequently with meloxicam at doses of 7.5 and 15 mg than with other NSAIDs with which the comparison was made. This difference in the frequency of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam, such phenomena as dyspepsia, vomiting, nausea, and abdominal pain were less often observed. The incidence of upper GI perforations, ulcers, and bleeding associated with meloxicam was low and dose dependent.

Pharmacokinetics

Meloxicam is well absorbed from the gastrointestinal tract, as evidenced by the high absolute bioavailability (90%) after oral administration. After a single use of meloxicam, Cmax in plasma is achieved within 5-6 hours. Simultaneous intake of food and inorganic antacids does not change absorption. When administered orally (in doses of 7.5 and 15 mg), the concentration of meloxicam is proportional to the dose. The steady state of pharmacokinetics is achieved within 3-5 days. The range of differences between Cmax and Cmin of the drug after taking it 1 time / day is relatively small and amounts to 0.4-1.0 ?g / ml when using a dose of 7.5 mg, and when using a dose of 15 mg - 0.8-2.0 ?g / ml (the values ??of Cmin and Cmax during steady state pharmacokinetics), although values ??outside the specified range were also noted.Cmax in plasma during the period of steady state pharmacokinetics is achieved 5-6 hours after oral administration.

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.

Application during pregnancy and lactation

Use during pregnancy and breastfeeding is contraindicated.

Application for violations of liver function

Contraindicated for use in severe liver failure, active liver disease. No dose adjustment is required in patients with (compensated) cirrhosis of the liver.

Application for impaired renal function

It is contraindicated for use in severe renal failure (if hemodialysis is not performed, CC <30 ml / min, as well as with confirmed hyperkalemia). Use with caution in renal failure (CC 30-60 ml / min). In patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg / day.

Use in elderly patients

It should be used with caution in elderly patients.

special instructions

Patients with gastrointestinal diseases require regular monitoring. If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, 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, especiallyif similar 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 together with diuretics can lead to sodium retention,potassium and water, as well as to reduce the natriuretic effect of diuretics. As a result, predisposed patients may experience increased signs of heart failure or 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 monitor the identified laboratory changes. 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 to 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.in this connection, 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 to 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.in this connection, 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 to 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.and 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 to 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.and 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 to 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 the use 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 admission. 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 potential for pharmacokinetic interactions 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.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.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.

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