Meloxicam 7.5mg Table 20 pcs Medisorb


Meloxicam 7.5mg Table 20 pcs Medisorb



Active substance:
1 tablet contains: meloxicam 7.5 mg or 15.0 mg ;.
Lactose monohydrate (milk sugar) 80.5 mg or 161 mg; povidone (polyvinylpyrrolidone) 4.0 mg or 8.0 mg; potato starch, 7.0 mg or 14.0 mg; magnesium stearate 1.0 mg or 2.0 mg.
Round Valium tablets of light yellow color with beveled.
Product form:
Tablets of 7.5 mg and 15 mg.
10 tablets in blisters.
20, 30, 50 or 100 tablets per polymeric jars.
Each bank or 1, 2, 3, 5, 10 contour cell packages together with instructions for use placed in a pile of cardboard boxed.
– hypersensitivity to the active ingredient or auxiliary ingredients. There is a possibility of cross-sensitivity to aspirin and other NSAIDs; – full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history); – erosive and ulcerative lesions of the stomach and duodenum (KDP) in the acute stage or recently transferred; – inflammatory bowel disease – Crohn’s disease or ulcerative colitis in the acute stage; – severe hepatic impairment; – severe renal failure (if left hemodialysis, creatinine clearance less than 30 mL / min, and when confirmed hyperkalemia), progressive kidney disease; – active gastrointestinal bleeding, cerebrovascular bleeding recently transferred or established diagnosis of diseases of the blood coagulation system; – severe uncontrolled heart failure; – treatment of perioperative pain during coronary artery bypass surgery; – Children up to age 12 years; – lactose intolerance, lactase deficiency and glucose-galactose malabsorption.
Gastrointestinal diseases in history (gastric ulcer and duodenum, liver disease); congestive heart failure; renal failure (creatinine clearance of 30-60 ml / min); coronary artery disease; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; concomitant therapy following preparations: oral steroids, anticoagulants (including warfarin), antiplatelet agents, selective serotonin reuptake inhibitor (including citalopram, fluoxetine, paroxetine, sertraline); peripheral artery disease; elderly age; long-term use of NSAIDs; smoking; Frequent use of alcohol.
7.5 mg
Symptomatic treatment of: – osteoarthritis (arthrosis, degenerative joint disease), including those with painful component; – rheumatoid arthritis; – ankylosing spondylitis.
Interaction with other drugs
Other PG synthesis inhibitors, including corticosteroids and salicylates: simultaneous with meloxicam increases the risk of formation of ulcers in the gastrointestinal tract and gastrointestinal bleeding (due to synergistic actions). Simultaneous treatment with other NSAIDs is not recommended.
Oral anticoagulants, heparin for systemic use, thrombolytic agents: concomitant use of meloxicam with an increased risk of bleeding. In the case of simultaneous application of careful monitoring of the blood coagulation system.
Antiplatelet drugs, selective serotonin reuptake inhibitors: concomitant use of meloxicam with an increased risk of bleeding due to inhibition of platelet function. In the case of simultaneous application of careful monitoring of the blood coagulation system.
lithium Formulations: NSAIDs increase the level of lithium in the blood plasma, by reducing its excretion by the kidneys. The simultaneous use of meloxicam with lithium therapy is not recommended. If necessary, the simultaneous use recommended careful control of the concentration of lithium in the blood plasma during the course of application of drugs lithium.
Methotrexate: Methotrexate NSAIDs reduce the secretion by the kidneys, thereby increasing its concentration in blood plasma. The simultaneous use of meloxicam and methotrexate (in a dose of 15 mg per week) did not recommended. In the case of simultaneous use of careful monitoring of renal function and blood formula. Meloxicam may enhance methotrexate hematologic toxicity, particularly in patients with impaired renal function.
When the joint application of meloxicam and methotrexate within 3 days increases the risk of increasing the toxicity of the latter.
Contraception: there is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices, but this is not proven.
Diuretics: NSAIDs in the case of dehydration of patients with a risk of developing acute renal failure.
Antihypertensive agents (beta-blockers, angiotensin converting enzyme (ACE) inhibitors, vasodilators, diuretics): NSAIDs reduce the effect of antihypertensive agents due to inhibition of PG having vasodilating properties.
Antagonists of angiotensin II receptor when coadministered with NSAIDs decreased glomerular filtration increase, thereby, may lead to the development of acute renal failure, especially in patients with impaired renal function.
Cholestyramine: linking meloxicam in the gastrointestinal tract, leading to its more rapid removal.
NSAIDs, exerting effects on renal PG can enhance cyclosporine nephrotoxicity.
Mifepristone: NSAIDs should not be used, including acetylsalicylic acid for 8-12 days after administration of mifepristone, as NSAIDs may affect the efficacy of treatment with mifepristone.
When used in conjunction with meloxicam drugs which have a certain ability to inhibit CYP2C9, and / or CYP3A4 (or metabolized with the participation of these enzymes) should take into account the possibility of a pharmacokinetic interaction.
We can not exclude the possibility of interaction with antidiabetic drugs for oral administration.
At the same time taking antacids, cimetidine, digoxin and furosemide significant pharmacokinetic interactions have been identified.
Data on cases of drug overdose, it has accumulated enough. Likely to present symptoms characteristic of an overdose of NSAIDs, in severe cases, drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole.
Treatment: an antidote is not known, in the case of overdose should be carried out: the evacuation of the stomach contents and general supportive therapy. Cholestyramine accelerates the elimination of meloxicam.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug.
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) refers to a derivative enolovoy acid and has anti-inflammatory, analgesic and antipyretic action. Pronounced antiinflammatory action of meloxicam is set on all standard models of inflammation. The mechanism of action of meloxicam is its ability to inhibit the synthesis of prostaglandins (PG) – known inflammatory mediators.
Meloxicam in vivo inhibits PG synthesis to the site of inflammation to a greater extent than in the gastric mucosa and kidney.
These differences are associated with a selective inhibition of cyclooxygenase-2 (COX-2) over cyclooxygenase-1 (COX-1). It is believed that inhibition of COX-2 provides therapeutic effects of NSAIDs, while the inhibition constant present isoenzyme COX-1 may be responsible for side effects in the stomach and kidney. Meloxicam selectivity for COX-2 was confirmed in various test systems as in vitro, and in vivo. Selective meloxicam ability to inhibit COX-2 is shown when used as a test system in vitro human whole blood. It has been established that meloxicam (at doses of 7.5 and 15 mg) actively inhibited COX-2 by providing a greater inhibitory effect on PG E2 production stimulated by lipopolysaccharide (reaction controlled by COX-2) than for the products of a thromboxane involved in blood clotting (reaction controlled by COX-1). These effects depend on the dose. In Ex vivo studies demonstrated that meloxicam at recommended doses had no effect on platelet aggregation, and bleeding time.
In clinical studies, side effects from the gastrointestinal tract (GIT) is generally less likely to arise when receiving meloxicam 7.5 mg and 15 than the reception of other NSAIDs, which were compared. This difference in the incidence of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam rarely observed phenomena such as dyspepsia, vomiting, nausea, abdominal pain. The frequency of the perforations in the upper gastrointestinal tract ulceration and bleeding, are contacted with meloxicam, it was low and was dependent on the dose of the drug.
Meloxicam is well absorbed from the gastrointestinal tract, as evidenced by high availability absolute (90%) after ingestion of the drug. After a single application of meloxicam maximum plasma concentration of the drug attained within 5-6 hours. Simultaneous food intake and inorganic antacids does not alter absorption. When using the drug administration (at doses of 7.5 and 15 mg) doses are proportional to its concentration. Steady state pharmacokinetics is achieved within 3-5 days. The range differences between the maximum and basal concentrations of the drug after administration once a day is relatively small and is at a dose of 7.5 mg 0.4-1.0 g / ml, and at a dose of 15 mg – 0.8-2, 0 g / ml (shown respectively the maximum and minimum values ​​of the plasma concentrations (Cmax and Cmin) during the steady state pharmacokinetics), but were also observed values ​​outside the specified range. Cmax meloxicam in plasma during steady-state pharmacokinetics is achieved 5-6 hours after ingestion.
Meloxicam very well bound to plasma proteins, mainly albumin (99%). Penetrates into the synovial fluid, synovial fluid concentration of 50% in blood plasma concentration. The volume of distribution following multiple dose meloxicam inward (in doses from 7.5 to 15 mg) is about 16 liters, with a coefficient of variation from 11 to 32%.
Meloxicam is almost completely metabolized in the liver to form 4 pharmacologically inactive metabolites. The main metabolite, 5-karboksimeloksikam (60% of the dose), formed by oxidation of an intermediate metabolite of 5- gidroksimetilmeloksikama which is also excreted, but to a lesser extent (9% of the dose). This metabolic conversion plays an important role isoenzyme CYP2C9, additional value is CYP3A4 isoenzyme. The formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase activity which probably varies individually.
Displayed equally through the intestine and the kidney, mainly in the form of metabolites. In an unmodified form with the faeces derived at least 5% of the daily dose in the urine as unchanged drug is detected only in trace amounts. The average half-life (T1 / 2) of meloxicam ranging from 13 to 25 hours. Plasma clearance averages 12.7 ml / min after a single dose of meloxicam.
Lack of liver and / or kidney
Liver failure, and kidney failure weakly expressed significant effect on the pharmacokinetics of meloxicam has not. The rate of excretion from the body of meloxicam significantly higher in patients with moderate renal insufficiency. Meloxicam is worse is bound to plasma proteins in patients with end-stage renal failure. When ESRD increase in the volume of distribution can result in higher concentrations of free meloxicam, so these patients the daily dose should not exceed 7.5 mg.
elderly patients
Elderly patients compared to younger patients have similar pharmacokinetic parameters. In elderly patients, the mean plasma clearance between the equilibrium state pharmacokinetics is slightly lower than in younger patients. In women older higher values ​​of area under the curve “concentration – time» (AUC) and a long T1 / 2, compared to young patients of both sexes.
Pregnancy and breast-feeding
Use of the drug is contraindicated during pregnancy. It is known that NSAIDs penetrate into breast milk, however, use during breast feeding is contraindicated.
Use of the drug can affect fertility, so it is not recommended for women planning pregnancy.
Meloxicam may lead to delay ovulation. Therefore, in women who have difficulty conceiving and passing examination about such problems, it is recommended the abolition of the drug.
Conditions of supply of pharmacies
side effects
The frequency of side effects was evaluated as follows: very often (> 1/10); common (> 1/100,
special instructions
Patients suffering from gastrointestinal diseases, should be monitored regularly. In the event of gastrointestinal ulceration or gastrointestinal bleeding medication should be abolished. Ulcers in the gastrointestinal tract, perforation or bleeding may occur during the treatment at any time, as in the presence of warning signs or information about serious gastrointestinal complications in history, and in the absence of these signs. The consequences of these complications are generally more severe in elderly patients.
In applying such NSAIDs may develop severe skin reactions as the exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Therefore, you should pay special attention to patients reporting of adverse events by the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during the previous courses of treatment. The development of such reactions occur usually within the first month of treatment. In the case of the first signs of skin rash, mucosal changes or other signs of hypersensitivity necessary to consider discontinuing use of the drug.
The drug can increase the risk of serious cardiovascular thrombosis, myocardial infarction, angina, possibly fatal. This risk increases with prolonged use of the drug, as well as in patients with the above diseases in history and predisposed to such diseases.
NSAIDs inhibit the renal synthesis of prostaglandins, which are involved in the maintenance of renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or a reduced amount of circulating blood can lead to hidden flowing decompensation of kidney failure. After the cancellation of NSAIDs renal function is usually restored to its original level. The greatest risk for this reaction is subject to elderly patients and patients who have marked dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome, or acute renal dysfunction, patients simultaneously receiving diuretic drugs, ACE inhibitors, antagonists of angiotensin II receptors, as well as patients undergoing major surgical procedures, which lead to gipovoliemii. In these patients, early treatment should be carefully monitored urine output and renal function.
The use of NSAIDs in conjunction with diuretics may lead to sodium retention, potassium and water, as well as to reduce the action of natriuretic diuretics. As a result, in predisposed patients may increase symptoms of heart failure or hypertension. Therefore, careful monitoring of the status of these patients, as well as their adequate hydration should be maintained. Prior to the beginning of treatment should be a study of kidney function.
In the case of combination therapy must also monitor renal function.
When using meloxicam (as well as most other NSAIDs) may episodic increased activity of “liver” transaminases in blood serum or other indicators of liver function. In most cases, this increase was slight and transient. If the identified changes are significant or not decrease with time, the drug you want to cancel and carry out further monitoring of identified laboratory changes.
Weakened or depleted patients can tolerate worse adverse events, and therefore, these patients should be monitored closely.
Like other NSAIDs Meloxicam may mask symptoms of primary infection.
As a drug that inhibits the synthesis of cyclooxygenase / prostaglandin, meloxicam may have an impact on fertility, so the drug is not recommended for women who have difficulty conceiving. Therefore, in women undergoing a survey on the subject recommended the abolition of the drug.
Patients with mild or moderate renal impairment (creatinine clearance greater than 25 mL / min) a dose adjustment is required.
In patients with cirrhosis (compensated) dose adjustment is required.
Effects on ability to drive and operate machinery
Specific clinical studies of the effect of the drug on the ability to operate vehicles and operating mechanisms are not performed. When driving and operating machinery should take into account the possibility of dizziness, drowsiness, visual disturbances or other disorders of the central nervous system. Patients should be careful when driving vehicles and management mechanisms.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, during a meal time, a daily dose of 7.5 – 15 mg.
The maximum recommended daily dose – 15 mg.
In osteoarthritis administered 7.5 mg a day, if necessary, this dose may be increased to 15 mg per day.
In rheumatoid arthritis of 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg daily.
In ankylosing spondylitis 15 mg per day. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в сутки. У пациентов с повышенным риском побочных реакций рекомендуется начинать лечение с дозы 7,5 мг в день.
У пациентов с выраженной почечной недостаточностью, находящихся на гемодиализе, доза не должна превышать 7,5 мг в сутки.
Общие рекомендации
Так как потенциальный риск побочных реакций зависит от дозы и продолжительностилечения следует использовать максимально возможные низкие дозы и длительность применения.
Комбинированное применение
You should not use the drug in conjunction with other NSAIDs.
Максимальная доза у подростков составляет 0,25 мг/кг. Препарат должен применяться у подростков старше 12 лет.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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